acronym: RA-BEYOND

title: A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis

ReferenceCitation: Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.

ReferenceCitation: Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.

ReferenceCitation: Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.

ReferenceCitation: Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.

ReferenceCitation: Winthrop KL, Bingham CO 3rd, Komocsar WJ, Bradley J, Issa M, Klar R, Kartman CE. Evaluation of pneumococcal and tetanus vaccine responses in patients with rheumatoid arthritis receiving baricitinib: results from a long-term extension trial substudy. Arthritis Res Ther. 2019 Apr 18;21(1):102. doi: 10.1186/s13075-019-1883-1.

ReferenceCitation: Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum in: J Rheumatol. 2019 Dec;46(12):1648-1649.

ReferenceCitation: Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.

ReferenceCitation: Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20. Review.

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Slovenia
Austria
Australia
Russian Federation
Argentina
Puerto Rico
India
Israel
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Latvia
Korea, Republic of
France
Netherlands

location_facility: Consultorios Asociados de Endocrinologia

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Catholic University of Korea Yeouido St. Mary's Hospital

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Clinical Emergency Hospital N.V.Solovyov

location_facility: 1st Hospital affiliated to Medical College of Shantou Univer

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet

location_facility: Szabolcs-Szatmar-Bereg M-i Korhazak es Egyetemi Oktatokorhaz

location_facility: Kondo Clinic for Rheumatism and Orthopaedics

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: Arthritis and Osteoporosis Consultants of the Carolinas

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Yoshida Orthopaedic and Rheumatic Clinic

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: V.A. Nasonova Research Institute of Rheumatology

location_facility: West Broward Rheumatology Associates, Inc

location_facility: Spital Clinic Judetean de Urgenta Tg.Mures

location_facility: Centro de Alta Especialidad Reumatologia e Inv Potosi, S.C.

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier

location_facility: Xiangya Hospital, Central South University

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

location_facility: Rheumatology Associates of Central Florida

location_facility: Afflilated Hospital of Bengbu Medical College

location_facility: Basingstoke and North Hampshire Hospital

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Manipal Centre for Clinical Research (MCCR)

location_facility: Mexico Centre for Clinical Research SA de CV

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Instituto Medico de Alta Complejidad San Isidro

location_facility: Allergy and Rheumatology Medical Clinic Inc

location_facility: Arizona Arthritis & Rheumatology Associates, P. C.

location_facility: Organizacion Medica de Investigacion - OMI

location_facility: Centro de Enfermedades del Higado y Aparato Digestivo

location_facility: Pauls Stradins Kliniska Universitates Slimnica

location_facility: Immunologisches Zentrum Vogelsang-Gommern GmbH

location_facility: Kyunghee University Hospital at Gangdong

location_facility: Shizuoka Rheumatism orthopedic Rehabilitation Hospital

location_facility: CENIT Centro de Neurociencias, Investigación y Tratamiento

location_facility: Reumatologiska Kliniken Skånes universitetssjukhus Malmö

location_facility: Clinica de Investigacion en Reumatologia y Obesidad S. C.

location_facility: Hospital Privado Centro Medico de Cordoba SA

location_facility: KLES Prabhakar Kore Hospital and Medical Research Centre

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Carolina Rheumatology and Neurology Associates

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Centrum Badan Klinicznych PI-House sp. z o.o.

location_facility: Asheville Rheumatology & Osteoporosis Research Assoc, PA

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: Arthritis and Osteporosis Treatment and Research Center

location_facility: JA-Shizuoka Shizuoka-Kosei General Hospital

location_facility: Centro de Medicina Familiar Mindout Research

location_facility: University of Occupational and Enviromental Health

location_facility: City Clinical Hospital 1 named after N.I. Pirogov

location_facility: CIR Centro de Investigacions Reumatologicas

location_facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

location_facility: Tsuzuki Azuma Clinic: Primary care and Rheumatology

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta

location_facility: The First Affiliate Hospital of AnHui Medical University

location_facility: Comite Mexicano para la Prevencion de la Osteoporosis A.C.

location_facility: Krishna Institute of Medical Sciences Ltd.

location_facility: Yoshitama Clinic Rheumatology & Internal Medicine

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerative

location_facility: Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej

location_facility: University General Hospital of Heraklion

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: St Marianna University School of Medicine Hospital

location_facility: Hokkaido Medical Center for Rheumatic Diseases

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: Rheumatology Practice in Jaunliepaja Primary Health Care Cen

location_facility: Centro de Estudios de Investigacion Basica y Clinica, S.C.

location_facility: (AOA) Arthritis & Osteoporosis Associates

location_facility: Associacao de Assistencia a Crianca Deficiente (AACD)

location_facility: CEPIC - Centro Paulista de Investigação Clínica

location_facility: Center for Arthritis and Rheumatic Diseases, PC

location_facility: Daegu Catholic University Medical Center

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: CHUV Centre Hospitalier Universitaire Vaudois

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: Tokyo Women's Medical University East Medical Center

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: ELIMATES BRNO s.r.o. Revmatologicka ambulance

location_facility: Shri Nidan Hospital & Hope Fertility Centre

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Allergy Asthma Immunology of Rochester, AAIR Research Ctr

location_facility: Komagamine Orthopedic and Rheumatology Clinic

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Niagara Peninsula Arthritis Centre, Inc.

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu

location_facility: The Second Xiangya Hospital of Central South University

summary:
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study.

The study provides 7 years of additional treatment with baricitinib.


status: Completed

primary_purpose: Treatment

acronym: METEOR

intervention_type: Drug

title: A Phase 3, Randomized, Controlled Study of Cabozantinib (XL184) vs Everolimus in Subjects With Metastatic Renal Cell Carcinoma That Has Progressed After Prior VEGFR Tyrosine Kinase Inhibitor Therapy

study_completion_date_type: Actual

lead_sponsor: Exelixis

source: euctr

design_allocation: Randomized

study_type: Interventional

ReferenceType: derived

ReferenceCitation: Denize T, Farah S, Cimadamore A, Flaifel A, Walton E, Sticco-Ivins MA, Labaki C, Braun DA, Sun M, Wang E, Xie W, Choueiri TK, Signoretti S. Biomarkers of Angiogenesis and Clinical Outcomes to Cabozantinib and Everolimus in Patients with Metastatic Renal Cell Carcinoma from the Phase III METEOR Trial. Clin Cancer Res. 2022 Feb 15;28(4):748-755. doi: 10.1158/1078-0432.CCR-21-3088.

ReferenceCitation: Powles T, Choueiri TK, Motzer RJ, Jonasch E, Pal S, Tannir NM, Signoretti S, Kaldate R, Scheffold C, Wang E, Aftab DT, Escudier B, George DJ. Outcomes based on plasma biomarkers in METEOR, a randomized phase 3 trial of cabozantinib vs everolimus in advanced renal cell carcinoma. BMC Cancer. 2021 Aug 7;21(1):904. doi: 10.1186/s12885-021-08630-w. Erratum in: BMC Cancer. 2021 Sep 15;21(1):1023.

ReferenceCitation: Donskov F, Motzer RJ, Voog E, Hovey E, Grüllich C, Nott LM, Cuff K, Gil T, Jensen NV, Chevreau C, Negrier S, Depenbusch R, Bergmann L, Cornelio I, Champsaur A, Escudier B, Pal S, Powles T, Choueiri TK. Outcomes based on age in the phase III METEOR trial of cabozantinib versus everolimus in patients with advanced renal cell carcinoma. Eur J Cancer. 2020 Feb;126:1-10. doi: 10.1016/j.ejca.2019.10.032. Epub 2019 Dec 27.

ReferenceCitation: Flaifel A, Xie W, Braun DA, Ficial M, Bakouny Z, Nassar AH, Jennings RB, Escudier B, George DJ, Motzer RJ, Morris MJ, Powles T, Wang E, Huang Y, Freeman GJ, Choueiri TK, Signoretti S. PD-L1 Expression and Clinical Outcomes to Cabozantinib, Everolimus, and Sunitinib in Patients with Metastatic Renal Cell Carcinoma: Analysis of the Randomized Clinical Trials METEOR and CABOSUN. Clin Cancer Res. 2019 Oct 15;25(20):6080-6088. doi: 10.1158/1078-0432.CCR-19-1135. Epub 2019 Aug 1.

ReferenceCitation: Cella D, Escudier B, Tannir NM, Powles T, Donskov F, Peltola K, Schmidinger M, Heng DYC, Mainwaring PN, Hammers HJ, Lee JL, Roth BJ, Marteau F, Williams P, Baer J, Mangeshkar M, Scheffold C, Hutson TE, Pal S, Motzer RJ, Choueiri TK. Quality of Life Outcomes for Cabozantinib Versus Everolimus in Patients With Metastatic Renal Cell Carcinoma: METEOR Phase III Randomized Trial. J Clin Oncol. 2018 Mar 10;36(8):757-764. doi: 10.1200/JCO.2017.75.2170. Epub 2018 Jan 29.

ReferenceCitation: Escudier B, Powles T, Motzer RJ, Olencki T, Arén Frontera O, Oudard S, Rolland F, Tomczak P, Castellano D, Appleman LJ, Drabkin H, Vaena D, Milwee S, Youkstetter J, Lougheed JC, Bracarda S, Choueiri TK. Cabozantinib, a New Standard of Care for Patients With Advanced Renal Cell Carcinoma and Bone Metastases? Subgroup Analysis of the METEOR Trial. J Clin Oncol. 2018 Mar 10;36(8):765-772. doi: 10.1200/JCO.2017.74.7352. Epub 2018 Jan 8.

ReferenceCitation: Choueiri TK, Escudier B, Powles T, Tannir NM, Mainwaring PN, Rini BI, Hammers HJ, Donskov F, Roth BJ, Peltola K, Lee JL, Heng DYC, Schmidinger M, Agarwal N, Sternberg CN, McDermott DF, Aftab DT, Hessel C, Scheffold C, Schwab G, Hutson TE, Pal S, Motzer RJ; METEOR investigators. Cabozantinib versus everolimus in advanced renal cell carcinoma (METEOR): final results from a randomised, open-label, phase 3 trial. Lancet Oncol. 2016 Jul;17(7):917-927. doi: 10.1016/S1470-2045(16)30107-3. Epub 2016 Jun 5.

ReferenceCitation: Choueiri TK, Escudier B, Powles T, Mainwaring PN, Rini BI, Donskov F, Hammers H, Hutson TE, Lee JL, Peltola K, Roth BJ, Bjarnason GA, Géczi L, Keam B, Maroto P, Heng DY, Schmidinger M, Kantoff PW, Borgman-Hagey A, Hessel C, Scheffold C, Schwab GM, Tannir NM, Motzer RJ; METEOR Investigators. Cabozantinib versus Everolimus in Advanced Renal-Cell Carcinoma. N Engl J Med. 2015 Nov 5;373(19):1814-23. doi: 10.1056/NEJMoa1510016. Epub 2015 Sep 25.

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Sweden
Slovakia
Canada
Hungary
Germany
Denmark
Taiwan
Ireland
Finland
Korea, Republic of
France
Chile
Netherlands

summary: The purpose of this study is to evaluate the effect of Cabozantinib (XL184) compared with Everolimus (Afinitor) on progression-free survival (PFS) and overall survival (OS) in subjects with advanced renal cell cancer that has progressed after prior VEGFR tyrosine kinase inhibitor therapy.

lead_sponsor_type: industriel

status_simplified: Completed


type: EudraCT Number

title: A Double-Blind, Placebo-Controlled, Randomised, Phase II Study Evaluating the Efficacy and Safety of Addition of Continuous Multiple Line Bevacizumab Treatment to Lomustine in Second (2nd)-Line Followed by Standard of Care (SOC) in Third (3rd)-Line and Beyond Compared to Addition of Placebo, Following First Progression of Disease (PD1) in Patients With Glioblastoma (GBM) After First (1st)-Line Treatment With Radiotherapy, Temozolomide and Bevacizumab

summary: This multicenter, double-blind, placebo-controlled, randomized study will evaluate the efficacy and safety of the addition of bevacizumab treatment to lomustine (in 2nd-line [2L] treatment) and SOC (in 3rd-line [3L] and subsequent lines of treatment) following first-line disease progression (PD1) in participants with newly diagnosed glioblastoma. All enrolled participants will receive 1L treatment with radiotherapy, temozolomide, and bevacizumab. At PD1, eligible participants will be randomized (1:1) to receive 2L treatment with either bevacizumab plus lomustine or placebo plus lomustine. After second-line disease progression (PD2), participants will receive 3L treatment and will continue blinded bevacizumab or placebo with the addition of an SOC agent. Following third-line disease progression (PD3), participants will receive subsequent lines of treatment and will either continue blinded bevacizumab or placebo (at the discretion of the investigator), or switch to open-label bevacizumab (at the choice of the participant).

study_start_date_type: Actual

ReferenceCitation: Brandes AA, Gil-Gil M, Saran F, Carpentier AF, Nowak AK, Mason W, Zagonel V, Dubois F, Finocchiaro G, Fountzilas G, Cernea DM, Chinot O, Anghel R, Ghiringhelli F, Beauchesne P, Lombardi G, Franceschi E, Makrutzki M, Mpofu C, Urban HJ, Pichler J. A Randomized Phase II Trial (TAMIGA) Evaluating the Efficacy and Safety of Continuous Bevacizumab Through Multiple Lines of Treatment for Recurrent Glioblastoma. Oncologist. 2019 Apr;24(4):521-528. doi: 10.1634/theoncologist.2018-0290. Epub 2018 Sep 28.

ReferenceCitation: Brandes AA, Mason W, Pichler J, Nowak AK, Gil M, Saran F, Revil C, Lutiger B, Carpentier AF. Can bevacizumab prolong survival for glioblastoma patients through multiple lines of therapy? Future Oncol. 2014 May;10(7):1137-45. doi: 10.2217/fon.14.75.

lead_sponsor: Hoffmann-La Roche

location_country:
Croatia
Portugal
Spain
Greece
Austria
Estonia
Italy
Canada
Latvia
United Kingdom
France
Turkey
Romania
Sweden
Bulgaria

location_facility: Riga East Clinical University hospital, Clinic Gailezers, Dept of Neurosurgery

location_facility: Azienda Ospedaliera Le Molintte di Torino; Dipartimento Di Neurologia - Oncologia

location_facility: Institutul Oncologic Prof. Dr. Al. Trestioreanu Bucuresti

location_facility: Medizinische Universität Wien; Univ.Klinik für Innere Medizin I - Abt. für Onkologie

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Seconda

location_facility: IInstituto Oncologico de San Sebastian, Oncologikoa; Servicio de Oncologia

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

location_facility: Hôpital Central; Departement de Neuro-Oncologie

location_facility: Papageorgiou General Hospital; Medical Oncology

location_facility: Baskent Universitesi Tıp Fakultesi; Ic Hastalıkları Anabilim Dalı Tıbbi Onkoloji Bilim Dalı

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

location_facility: Norrlands Universitetssjukhus; Cancer Centrum

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Kepler Universitätsklinikum GmbH - Neuromed Campus; Innere Medizin mit Neuroonkologie

location_facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital de Cruces; Servicio de Oncologia

location_facility: Hopital de La Timone - CHU de Marseille; Service de neuro-oncologie - Hôpital Adultes - 12ème étage

location_facility: Fondazione IRCCS Istituto Neurologico C. Besta; Neuro-oncologia Sperimentale e Terapia Genica

location_facility: HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio de Oncologia

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Hopital Roger Salengro; Service de Neurologie

location_facility: University College Hospital; Department of Oncology

location_facility: Hopital Pitié Salpétrière - CHU; Service de neurologie 2 - Mazarin

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Centre Georges Francois Leclerc; Oncologie 3

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Hospital de Sao Joao; Servico de Oncologia

location_facility: Lkh Salzburg - Univ. Klinikum Salzburg; Iii. Medizinische Abt.

location_facility: Hopital Saint Andre; Département de Radiothérapie Et D'Oncologie Médicale

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: IPO de Coimbra; Servico de Oncologia Medica

intervention_type: Radiation


type: Other Identifier

title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate Dupilumab in Patients With Moderate to Severe Uncontrolled Asthma

summary:
Primary Objective:

To evaluate the efficacy of different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma.

Secondary Objective:

To evaluate different doses and regimens of dupilumab in participants with moderate to severe uncontrolled asthma, with regard to:

Safety and tolerability
Dupilumab systemic exposure and anti-drug antibodies

ReferenceType: result

ReferenceCitation: Wenzel S, Castro M, Corren J, Maspero J, Wang L, Zhang B, Pirozzi G, Sutherland ER, Evans RR, Joish VN, Eckert L, Graham NM, Stahl N, Yancopoulos GD, Louis-Tisserand M, Teper A. Dupilumab efficacy and safety in adults with uncontrolled persistent asthma despite use of medium-to-high-dose inhaled corticosteroids plus a long-acting β2 agonist: a randomised double-blind placebo-controlled pivotal phase 2b dose-ranging trial. Lancet. 2016 Jul 2;388(10039):31-44. doi: 10.1016/S0140-6736(16)30307-5. Epub 2016 Apr 27.

ReferenceCitation: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

ReferenceCitation: Bourdin A, Papi AA, Corren J, Virchow JC, Rice MS, Deniz Y, Djandji M, Rowe P, Pavord ID. Dupilumab is effective in type 2-high asthma patients receiving high-dose inhaled corticosteroids at baseline. Allergy. 2021 Jan;76(1):269-280. doi: 10.1111/all.14611. Epub 2020 Oct 21.

ReferenceCitation: Maspero JF, Katelaris CH, Busse WW, Castro M, Corren J, Chipps BE, Peters AT, Pavord ID, Ford LB, Sher L, Rabe KF, Rice MS, Rowe P, Lu Y, Harel S, Jagerschmidt A, Khan AH, Kamat S, Pirozzi G, Amin N, Ruddy M, Graham NMH, Mannent LP, Teper A. Dupilumab Efficacy in Uncontrolled, Moderate-to-Severe Asthma with Self-Reported Chronic Rhinosinusitis. J Allergy Clin Immunol Pract. 2020 Feb;8(2):527-539.e9. doi: 10.1016/j.jaip.2019.07.016. Epub 2019 Jul 24.

ReferenceCitation: Corren J, Castro M, Ford LB, Bernstein JA, Jayawardena S, Maroni J, Rowe P, Amin N, Pirozzi G, Graham NMH, Khan A, Eckert L, Teper A. Dupilumab improves asthma outcomes irrespective of frequency of previous asthma exacerbation history. Ann Allergy Asthma Immunol. 2019 Aug;123(2):222-224.e1. doi: 10.1016/j.anai.2019.04.028. Epub 2019 May 8.

ReferenceCitation: Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbé A, Taniou C, Mahajan P, Teper A, Pirozzi G, Eckert L. Dupilumab improves symptoms, quality of life, and productivity in uncontrolled persistent asthma. Ann Allergy Asthma Immunol. 2019 Jan;122(1):41-49.e2. doi: 10.1016/j.anai.2018.08.005. Epub 2018 Aug 21.

ReferenceCitation: Weinstein SF, Katial R, Jayawardena S, Pirozzi G, Staudinger H, Eckert L, Joish VN, Amin N, Maroni J, Rowe P, Graham NMH, Teper A. Efficacy and safety of dupilumab in perennial allergic rhinitis and comorbid asthma. J Allergy Clin Immunol. 2018 Jul;142(1):171-177.e1. doi: 10.1016/j.jaci.2017.11.051. Epub 2018 Jan 31.

lead_sponsor: Sanofi

location_country:
Poland
Spain
Italy
Russian Federation
Australia
New Zealand
Argentina
Ukraine
Korea, Republic of
United States
Chile
France
South Africa
Mexico
Japan
Turkey

location_facility:
Investigational Site Number 616008
Investigational Site Number 804019
Investigational Site Number 392014
Investigational Site Number 840027
Investigational Site Number 152008
Investigational Site Number 392006
Investigational Site Number 840006
Investigational Site Number 643006
Investigational Site Number 032001
Investigational Site Number 792007
Investigational Site Number 840022
Investigational Site Number 392038
Investigational Site Number 152012
Investigational Site Number 840028
Investigational Site Number 392003
Investigational Site Number 840040
Investigational Site Number 392037
Investigational Site Number 032003
Investigational Site Number 392008
Investigational Site Number 380003
Investigational Site Number 792008
Investigational Site Number 152005
Investigational Site Number 840044
Investigational Site Number 840030
Investigational Site Number 840051
Investigational Site Number 554001
Investigational Site Number 380010
Investigational Site Number 643012
Investigational Site Number 643010
Investigational Site Number 840053
Investigational Site Number 643007
Investigational Site Number 840013
Investigational Site Number 616005
Investigational Site Number 792003
Investigational Site Number 392040
Investigational Site Number 724005
Investigational Site Number 392004
Investigational Site Number 392029
Investigational Site Number 840024
Investigational Site Number 724003
Investigational Site Number 840018
Investigational Site Number 643009
Investigational Site Number 380007
Investigational Site Number 840045
Investigational Site Number 804020
Investigational Site Number 152011
Investigational Site Number 804015
Investigational Site Number 724004
Investigational Site Number 250007
Investigational Site Number 392035
Investigational Site Number 250004
Investigational Site Number 392032
Investigational Site Number 250001
Investigational Site Number 250005
Investigational Site Number 792001
Investigational Site Number 392041
Investigational Site Number 250003
Investigational Site Number 643002
Investigational Site Number 392017
Investigational Site Number 032008
Investigational Site Number 484003
Investigational Site Number 410005
Investigational Site Number 036009
Investigational Site Number 032004
Investigational Site Number 036008
Investigational Site Number 840004
Investigational Site Number 392042
Investigational Site Number 840025
Investigational Site Number 840033
Investigational Site Number 840032
Investigational Site Number 484001
Investigational Site Number 616007
Investigational Site Number 392012
Investigational Site Number 840046
Investigational Site Number 840026
Investigational Site Number 792002
Investigational Site Number 840002
Investigational Site Number 484006
Investigational Site Number 840003
Investigational Site Number 804006
Investigational Site Number 840014
Investigational Site Number 152003
Investigational Site Number 392036
Investigational Site Number 392026
Investigational Site Number 840037
Investigational Site Number 840041
Investigational Site Number 032006
Investigational Site Number 032010
Investigational Site Number 484005
Investigational Site Number 840001
Investigational Site Number 840048
Investigational Site Number 643011
Investigational Site Number 380009
Investigational Site Number 840029
Investigational Site Number 643003
Investigational Site Number 392005
Investigational Site Number 840020
Investigational Site Number 392018
Investigational Site Number 032002
Investigational Site Number 152001
Investigational Site Number 250008
Investigational Site Number 380006
Investigational Site Number 616001
Investigational Site Number 840031
Investigational Site Number 410001
Investigational Site Number 392019
Investigational Site Number 804002
Investigational Site Number 392020
Investigational Site Number 392001
Investigational Site Number 152014
Investigational Site Number 484004
Investigational Site Number 392022
Investigational Site Number 392034
Investigational Site Number 792004
Investigational Site Number 616004
Investigational Site Number 840042
Investigational Site Number 840007
Investigational Site Number 616003
Investigational Site Number 250011
Investigational Site Number 840011
Investigational Site Number 410004
Investigational Site Number 724006
Investigational Site Number 380004
Investigational Site Number 392010
Investigational Site Number 036003
Investigational Site Number 840015
Investigational Site Number 392045
Investigational Site Number 792006
Investigational Site Number 152006
Investigational Site Number 036006
Investigational Site Number 554002
Investigational Site Number 804004
Investigational Site Number 032007
Investigational Site Number 380008
Investigational Site Number 392021
Investigational Site Number 250009
Investigational Site Number 032005
Investigational Site Number 840017
Investigational Site Number 392023
Investigational Site Number 643008
Investigational Site Number 250010
Investigational Site Number 840016
Investigational Site Number 392030
Investigational Site Number 392013
Investigational Site Number 724007
Investigational Site Number 792005
Investigational Site Number 380002
Investigational Site Number 152002
Investigational Site Number 840036
Investigational Site Number 032009
Investigational Site Number 804018
Investigational Site Number 392028
Investigational Site Number 840019
Investigational Site Number 710001
Investigational Site Number 840035
Investigational Site Number 840008
Investigational Site Number 410002
Investigational Site Number 804012
Investigational Site Number 804008
Investigational Site Number 380001
Investigational Site Number 392044
Investigational Site Number 840054
Investigational Site Number 840021
Investigational Site Number 250002
Investigational Site Number 840039
Investigational Site Number 840034
Investigational Site Number 152007
Investigational Site Number 792011
Investigational Site Number 804001
Investigational Site Number 392002
Investigational Site Number 152013
Investigational Site Number 724002
Investigational Site Number 804016
Investigational Site Number 250006
Investigational Site Number 036001
Investigational Site Number 840043
Investigational Site Number 840009
Investigational Site Number 840023
Investigational Site Number 804003
Investigational Site Number 616006
Investigational Site Number 724001
Investigational Site Number 840010
Investigational Site Number 036005
Investigational Site Number 392009
Investigational Site Number 392011
Investigational Site Number 643001
Investigational Site Number 840050
Investigational Site Number 392024
Investigational Site Number 710002
Investigational Site Number 792013
Investigational Site Number 840052
Investigational Site Number 392015
Investigational Site Number 410003
Investigational Site Number 032012
Investigational Site Number 840005
Investigational Site Number 036004
Investigational Site Number 392043
Investigational Site Number 392007
Investigational Site Number 380005
Investigational Site Number 036002
Investigational Site Number 392025


title: Evaluation of the Benefits and Risks in Maintenance Renal Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based Immunosuppression

lead_sponsor: Bristol-Myers Squibb

location_country:
Austria
Netherlands
Argentina
Switzerland
Sweden
United States
France
Colombia
Norway
Germany

location_facility: Tulane University Health Sciences Center

location_facility: University of Colorado Denver (PI Address)

location_facility: Memorial Hermann - Texas Medical Center (Tmc), The University Of Texas Medical School At Houston

location_facility: Virginia Commonwealth University Medical Center

location_facility: Medical College of Georgia at Augusta University

location_facility: University of Iowa Health Care (PI Address)

location_facility: Florida Hospital Transplant Institute (PI Address)

location_facility: University Hospitals Cleveland Medical Center

location_facility: University of Virginia Health System (PI Address)

location_facility: Medical College of WI Froedtert Hospital

location_facility: Swedish Medical Center-Swedish Organ Transplant and Liver Center

location_facility: University of Wisconsin School of Medicine and Public Health (PI Address)

location_facility: Baylor All Saints Medical Center at Ft. Worth

location_facility: RUSH University Transplant Program (PI Address)

location_facility: Loma Linda University Medical Center (LLUMC) - Children's Hospital - Transplantation Institute

location_facility: University of Utah Depart of Nephrology (PI Address)

location_facility: University of Washington Medical Center (PI Address & Study Supplies Address)

location_facility: University of California, San Francisco (UCSF)-Kidney Transplant Service

location_facility: Methodist University Hospital Transplant Institute (PI Address)

location_facility: Medical University of South Carolina, SCTR Research Nexus

location_facility: East Carolina Univ Nephrology Clin Res. Lab

location_facility: Vanderbilt University Medical Center- GI Research Office

location_facility: Providence Sacred Heart Medical Center and Childrens Hospital

location_facility: Transplant Research Institute (PI Address)

location_facility: Recanati/Miller Transplantation Institue (PI Address)

location_facility: California Pacific Medical Center, Depart of Transplantation (PI Address)

summary: The primary purpose is to assess the benefits and risks of changing from Cyclosporine or Tacrolimus to Belatacept between 6-60 months after kidney transplant.


title: Dapagliflozin Effect on Cardiovascular Events A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Dapagliflozin 10 mg Once Daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischemic Stroke in Patients With Type 2 Diabetes

summary: This study is being carried out to determine the effect of dapagliflozin on cardiovacular outcomes when added to current background therapy in patients with type 2 diabetes with either established cardiovacular disease or cardiovascular risk factors.

ReferenceCitation: Mosenzon O, Raz I, Wiviott SD, Schechter M, Goodrich EL, Yanuv I, Rozenberg A, Murphy SA, Zelniker TA, Langkilde AM, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Wilding JPH, McGuire DK, Bhatt DL, Leiter LA, Cahn A, Dwyer JP, Heerspink HJL, Sabatine MS. Dapagliflozin and Prevention of Kidney Disease Among Patients With Type 2 Diabetes: Post Hoc Analyses From the DECLARE-TIMI 58 Trial. Diabetes Care. 2022 Oct 1;45(10):2350-2359. doi: 10.2337/dc22-0382.

ReferenceCitation: Oyama K, Raz I, Cahn A, Goodrich EL, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Efficacy and Safety of Dapagliflozin According to Background Use of Cardiovascular Medications in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2022 Sep 1;7(9):914-923. doi: 10.1001/jamacardio.2022.2006.

ReferenceCitation: Furtado RHM, Raz I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Aylward P, Dalby AJ, Dellborg M, Dimulescu D, Nicolau JC, Oude Ophuis AJM, Cahn A, Mosenzon O, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Efficacy and Safety of Dapagliflozin in Type 2 Diabetes According to Baseline Blood Pressure: Observations From DECLARE-TIMI 58 Trial. Circulation. 2022 May 24;145(21):1581-1591. doi: 10.1161/CIRCULATIONAHA.121.058103. Epub 2022 May 5.

ReferenceCitation: Cahn A, Wiviott SD, Mosenzon O, Goodrich EL, Murphy SA, Yanuv I, Rozenberg A, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Raz I. Association of Baseline HbA1c With Cardiovascular and Renal Outcomes: Analyses From DECLARE-TIMI 58. Diabetes Care. 2022 Apr 1;45(4):938-946. doi: 10.2337/dc21-1744.

ReferenceCitation: Oyama K, Raz I, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Park KS, Goudev A, Diaz R, Špinar J, Gause-Nilsson IAM, Mosenzon O, Sabatine MS, Wiviott SD. Obesity and effects of dapagliflozin on cardiovascular and renal outcomes in patients with type 2 diabetes mellitus in the DECLARE-TIMI 58 trial. Eur Heart J. 2022 Aug 14;43(31):2958-2967. doi: 10.1093/eurheartj/ehab530.

ReferenceCitation: Mosenzon O, Wiviott SD, Heerspink HJL, Dwyer JP, Cahn A, Goodrich EL, Rozenberg A, Schechter M, Yanuv I, Murphy SA, Zelniker TA, Gause-Nilsson IAM, Langkilde AM, Fredriksson M, Johansson PA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Sabatine MS, Raz I. The Effect of Dapagliflozin on Albuminuria in DECLARE-TIMI 58. Diabetes Care. 2021 Aug;44(8):1805-1815. doi: 10.2337/dc21-0076. Epub 2021 Jul 7.

ReferenceCitation: Cherney DZI, Dagogo-Jack S, McGuire DK, Cosentino F, Pratley R, Shih WJ, Frederich R, Maldonado M, Liu J, Wang S, Cannon CP; VERTIS CV Investigators. Kidney outcomes using a sustained >/=40% decline in eGFR: A meta-analysis of SGLT2 inhibitor trials. Clin Cardiol. 2021 Aug;44(8):1139-1143. doi: 10.1002/clc.23665. Epub 2021 Jun 15.

ReferenceCitation: Zelniker TA, Raz I, Mosenzon O, Dwyer JP, Heerspink HHJL, Cahn A, Goodrich EL, Im K, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson I, Langkilde AM, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Cardiovascular Outcomes According to Baseline Kidney Function and Albuminuria Status in Patients With Type 2 Diabetes: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2021 Jul 1;6(7):801-810. doi: 10.1001/jamacardio.2021.0660.

ReferenceCitation: Cahn A, Raz I, Leiter LA, Mosenzon O, Murphy SA, Goodrich EL, Yanuv I, Rozenberg A, Bhatt DL, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Langkilde AM, Sabatine MS, Wiviott SD. Cardiovascular, Renal, and Metabolic Outcomes of Dapagliflozin Versus Placebo in a Primary Cardiovascular Prevention Cohort: Analyses From DECLARE-TIMI 58. Diabetes Care. 2021 May;44(5):1159-1167. doi: 10.2337/dc20-2492. Epub 2021 Mar 2.

ReferenceCitation: O'Donoghue ML, Kato ET, Mosenzon O, Murphy SA, Cahn A, Herrera M, Tankova T, Šmahelová A, Merlini P, Gause-Nilsson I, Langkilde AM, McGuire DK, Wilding JPH, Leiter LA, Bhatt DL, Raz I, Sabatine MS, Wiviott SD. The efficacy and safety of dapagliflozin in women and men with type 2 diabetes mellitus. Diabetologia. 2021 Jun;64(6):1226-1234. doi: 10.1007/s00125-021-05399-2. Epub 2021 Feb 20.

ReferenceCitation: Bonaca MP, Wiviott SD, Zelniker TA, Mosenzon O, Bhatt DL, Leiter LA, McGuire DK, Goodrich EL, De Mendonca Furtado RH, Wilding JPH, Cahn A, Gause-Nilsson IAM, Johanson P, Fredriksson M, Johansson PA, Langkilde AM, Raz I, Sabatine MS. Dapagliflozin and Cardiac, Kidney, and Limb Outcomes in Patients With and Without Peripheral Artery Disease in DECLARE-TIMI 58. Circulation. 2020 Aug 25;142(8):734-747. doi: 10.1161/CIRCULATIONAHA.119.044775. Epub 2020 Aug 3.

ReferenceCitation: Zelniker TA, Bonaca MP, Furtado RHM, Mosenzon O, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Budaj A, Kiss RG, Padilla F, Gause-Nilsson I, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Atrial Fibrillation in Patients With Type 2 Diabetes Mellitus: Insights From the DECLARE-TIMI 58 Trial. Circulation. 2020 Apr 14;141(15):1227-1234. doi: 10.1161/CIRCULATIONAHA.119.044183. Epub 2020 Jan 27.

ReferenceCitation: Cahn A, Mosenzon O, Wiviott SD, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Efficacy and Safety of Dapagliflozin in the Elderly: Analysis From the DECLARE-TIMI 58 Study. Diabetes Care. 2020 Feb;43(2):468-475. doi: 10.2337/dc19-1476. Epub 2019 Dec 16.

ReferenceCitation: Berg DD, Wiviott SD, Scirica BM, Gurmu Y, Mosenzon O, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Johanson P, Johansson PA, Langkilde AM, Raz I, Braunwald E, Sabatine MS. Heart Failure Risk Stratification and Efficacy of Sodium-Glucose Cotransporter-2 Inhibitors in Patients With Type 2 Diabetes Mellitus. Circulation. 2019 Nov 5;140(19):1569-1577. doi: 10.1161/CIRCULATIONAHA.119.042685. Epub 2019 Aug 31.

ReferenceCitation: Mosenzon O, Wiviott SD, Cahn A, Rozenberg A, Yanuv I, Goodrich EL, Murphy SA, Heerspink HJL, Zelniker TA, Dwyer JP, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Kato ET, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS, Raz I. Effects of dapagliflozin on development and progression of kidney disease in patients with type 2 diabetes: an analysis from the DECLARE-TIMI 58 randomised trial. Lancet Diabetes Endocrinol. 2019 Aug;7(8):606-617. doi: 10.1016/S2213-8587(19)30180-9. Epub 2019 Jun 10. Erratum in: Lancet Diabetes Endocrinol. 2019 Aug;7(8):e20.

ReferenceCitation: Furtado RHM, Bonaca MP, Raz I, Zelniker TA, Mosenzon O, Cahn A, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Nicolau JC, Gause-Nilsson IAM, Fredriksson M, Langkilde AM, Sabatine MS, Wiviott SD. Dapagliflozin and Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus and Previous Myocardial Infarction. Circulation. 2019 May 28;139(22):2516-2527. doi: 10.1161/CIRCULATIONAHA.119.039996. Epub 2019 Mar 18.

ReferenceCitation: Kato ET, Silverman MG, Mosenzon O, Zelniker TA, Cahn A, Furtado RHM, Kuder J, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Bonaca MP, Ruff CT, Desai AS, Goto S, Johansson PA, Gause-Nilsson I, Johanson P, Langkilde AM, Raz I, Sabatine MS, Wiviott SD. Effect of Dapagliflozin on Heart Failure and Mortality in Type 2 Diabetes Mellitus. Circulation. 2019 May 28;139(22):2528-2536. doi: 10.1161/CIRCULATIONAHA.119.040130. Epub 2019 Mar 18.

ReferenceCitation: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Zelniker TA, Kuder JF, Murphy SA, Bhatt DL, Leiter LA, McGuire DK, Wilding JPH, Ruff CT, Gause-Nilsson IAM, Fredriksson M, Johansson PA, Langkilde AM, Sabatine MS; DECLARE-TIMI 58 Investigators. Dapagliflozin and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2019 Jan 24;380(4):347-357. doi: 10.1056/NEJMoa1812389. Epub 2018 Nov 10.

ReferenceCitation: Wiviott SD, Raz I, Bonaca MP, Mosenzon O, Kato ET, Cahn A, Silverman MG, Bansilal S, Bhatt DL, Leiter LA, McGuire DK, Wilding JP, Gause-Nilsson IA, Langkilde AM, Johansson PA, Sabatine MS. The design and rationale for the Dapagliflozin Effect on Cardiovascular Events (DECLARE)-TIMI 58 Trial. Am Heart J. 2018 Jun;200:83-89. doi: 10.1016/j.ahj.2018.01.012. Epub 2018 Feb 7.

ReferenceCitation: Wittbrodt ET, Eudicone JM, Bell KF, Enhoffer DM, Latham K, Green JB. Eligibility varies among the 4 sodium-glucose cotransporter-2 inhibitor cardiovascular outcomes trials: implications for the general type 2 diabetes US population. Am J Manag Care. 2018 Apr;24(8 Suppl):S138-S145.

ReferenceCitation: Bloch MJ. Blood pressure effects of SGLT2 inhibitors make them an attractive option in diabetic patients with hypertension. J Am Soc Hypertens. 2016 Mar;10(3):186-7.

ReferenceCitation: Leiter LA, Cefalu WT, de Bruin TW, Xu J, Parikh S, Johnsson E, Gause-Nilsson I. Long-term maintenance of efficacy of dapagliflozin in patients with type 2 diabetes mellitus and cardiovascular disease. Diabetes Obes Metab. 2016 Aug;18(8):766-74. doi: 10.1111/dom.12666. Epub 2016 May 12.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Philippines
Japan
Romania
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Australia
Argentina
India
Israel
Turkey
Mexico
Sweden
Slovakia
Brazil
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Thailand
Vietnam
Korea, Republic of
France
Netherlands


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence

ReferenceCitation: Ascierto PA, Lewis KD, Di Giacomo AM, Demidov L, Mandalà M, Bondarenko I, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Simmons B, Ye C, Hooper G, Wongchenko MJ, Goodman GR, Yan Y, Schadendorf D. Prognostic impact of baseline tumour immune infiltrate on disease-free survival in patients with completely resected, BRAF(v600) mutation-positive melanoma receiving adjuvant vemurafenib. Ann Oncol. 2020 Jan;31(1):153-159. doi: 10.1016/j.annonc.2019.10.002.

ReferenceCitation: Maio M, Lewis K, Demidov L, Mandalà M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAF(V600) mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. doi: 10.1016/S1470-2045(18)30106-2. Epub 2018 Feb 21. Erratum in: Lancet Oncol. 2018 Apr;19(4):e184.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Mexico
Norway
Sweden
Brazil
Canada
Switzerland
Germany
Ireland
Estonia
New Zealand
France
Netherlands

location_facility: Centro Regiomontano de Investigación Clínica

location_facility: The Angeles Clinic and Research Institute - W LA Office

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: Saint Boniface General Hospital; Section of Nephrology BG 007

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

location_facility: Tennessee Oncology PLLC - Nashville (20th Ave)

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Stanford University School of Medicine; Stanford Hospital Pharmacy

location_facility: Cancer Center Of Santa Barbara; Network Clinical Research Specialist

location_facility: Hospital do Espirito Santo; Servico de Oncologia Medica

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology

location_facility: UCLA Department of Medicine; Division of Hematology / Oncology

location_facility: Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Nottingham University Hospitals City Campus

location_facility: BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency

location_facility: Launceston General Hospital; Gastroenterology Research

location_facility: Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin

location_facility: Princess Margaret Hospital; Department of Med Oncology

location_facility: FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"

location_facility: TRIO-US Network Administration; Network Clinical Research Specialist

location_facility: IRCCS Istituto Clinico Humanitas; Farmacia

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

location_facility: Duke University Medical Center; Oncology

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

location_facility: Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: Scientific Research Oncology Institute named after N.N. Petrov

location_facility: CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU

location_facility: Washington University; Dept of Medicine/Div of Medical Oncology

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Hadassah University Hospital - Ein Kerem

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Indiana University Health; Goshen Center for Cancer Care

location_facility: Leids Universitair Medisch Centrum; Cardiology

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: University of Pennsylvania Health System

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Institute of Oncology and Radiology of Serbia

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Guys and St Thomas NHS Foundation Trust, Guys Hospital

location_facility: LHSC - Victoria Hospital; Department of Pediatrics

location_facility: Kaiser Foundation Hospital - Oakland (W. MacArthur)

location_facility: East Tallinn Central Hospital; Clinic of Internal Medicine

location_facility: University of Pretoria Oncology Department

location_facility: The Ottawa Hospital Cancer Center; General Campus

location_facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS

location_facility: University of Kansas Medical Center; Cancer Center

location_facility: Hospital Universitari i Politecnic La Fe

location_facility: Indiana University Department of Medicine; Division of Infectious Diseases

location_facility: U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Saint John Regional Hospital; Department of Oncology

location_facility: Hospital Costa del Sol; Servicio de Oncologia

location_facility: The Townsville Hospital; Townsville Cancer Centre

location_facility: Peninsula Oncology Centre; Frankston Private

location_facility: A.O.U. Senese Policlinico Santa Maria Alle Scotte

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: New York University Medical Center PRIME; NYU Clinical Cancer Center

location_facility: St. Mary's Hospital Regional Cancer Center

summary: This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.


title: A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Variable Treatment Duration Study Evaluating the Efficacy and Safety of Siponimod (BAF312) in Patients With Secondary Progressive Multiple Sclerosis Followed by Extended Treatment With Open-label BAF312.

summary: Evaluate the safety and efficacy of Siponimod (BAF312) versus placebo in a variable treatment duration in patients with secondary progressive multiple sclerosis (Core Part) followed by extended treatment with open-label BAF312 to obtain data on long-term safety, tolerability and efficacy (Extension Part).

status: Active, not recruiting

study_completion_date_type: Anticipated

ReferenceCitation: Gold R, Piani-Meier D, Kappos L, Bar-Or A, Vermersch P, Giovannoni G, Fox RJ, Arnold DL, Benedict RHB, Penner IK, Rouyrre N, Kilaru A, Karlsson G, Ritter S, Dahlke F, Hach T, Cree BAC. Siponimod vs placebo in active secondary progressive multiple sclerosis: a post hoc analysis from the phase 3 EXPAND study. J Neurol. 2022 Sep;269(9):5093-5104. doi: 10.1007/s00415-022-11166-z. Epub 2022 May 31.

ReferenceCitation: Cree BA, Arnold DL, Fox RJ, Gold R, Vermersch P, Benedict RH, Bar-Or A, Piani-Meier D, Rouyrre N, Ritter S, Kilaru A, Karlsson G, Giovannoni G, Kappos L. Long-term efficacy and safety of siponimod in patients with secondary progressive multiple sclerosis: Analysis of EXPAND core and extension data up to >5 years. Mult Scler. 2022 Sep;28(10):1591-1605. doi: 10.1177/13524585221083194. Epub 2022 Apr 5.

ReferenceCitation: Leppert D, Kropshofer H, Häring DA, Dahlke F, Patil A, Meinert R, Tomic D, Kappos L, Kuhle J. Blood Neurofilament Light in Progressive Multiple Sclerosis: Post Hoc Analysis of 2 Randomized Controlled Trials. Neurology. 2022 May 24;98(21):e2120-e2131. doi: 10.1212/WNL.0000000000200258. Epub 2022 Apr 4.

ReferenceCitation: Arnold DL, Piani-Meier D, Bar-Or A, Benedict RH, Cree BA, Giovannoni G, Gold R, Vermersch P, Arnould S, Dahlke F, Hach T, Ritter S, Karlsson G, Kappos L, Fox RJ; EXPAND Clinical Investigators. Effect of siponimod on magnetic resonance imaging measures of neurodegeneration and myelination in secondary progressive multiple sclerosis: Gray matter atrophy and magnetization transfer ratio analyses from the EXPAND phase 3 trial. Mult Scler. 2022 Sep;28(10):1526-1540. doi: 10.1177/13524585221076717. Epub 2022 Mar 9.

ReferenceCitation: Schur N, Gudala K, Vudumula U, Vadapalle S, Bhadhuri A, Casanova A, Adlard N, Schwenkglenks M. Cost Effectiveness and Budget Impact of Siponimod Compared to Interferon Beta-1a in the Treatment of Adult Patients with Secondary Progressive Multiple Sclerosis with Active Disease in Switzerland. Pharmacoeconomics. 2021 May;39(5):563-577. doi: 10.1007/s40273-021-01023-8. Epub 2021 Apr 1.

ReferenceCitation: Benedict RHB, Tomic D, Cree BA, Fox R, Giovannoni G, Bar-Or A, Gold R, Vermersch P, Pohlmann H, Wright I, Karlsson G, Dahlke F, Wolf C, Kappos L. Siponimod and Cognition in Secondary Progressive Multiple Sclerosis: EXPAND Secondary Analyses. Neurology. 2021 Jan 19;96(3):e376-e386. doi: 10.1212/WNL.0000000000011275. Epub 2020 Dec 16.

ReferenceCitation: Kappos L, Bar-Or A, Cree BAC, Fox RJ, Giovannoni G, Gold R, Vermersch P, Arnold DL, Arnould S, Scherz T, Wolf C, Wallström E, Dahlke F; EXPAND Clinical Investigators. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study. Lancet. 2018 Mar 31;391(10127):1263-1273. doi: 10.1016/S0140-6736(18)30475-6. Epub 2018 Mar 23. Erratum in: Lancet. 2018 Nov 17;392(10160):2170.

ipd_sharing: Yes

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Locations: central Contact Info Novartis.email@novartis.com

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Belgium
Japan
Romania
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Sweden
Slovakia
Canada
Switzerland
Hungary
China
Germany
Bulgaria
Greece
Ireland
Estonia
Latvia
France
Netherlands

status_simplified: Ongoing


title: The Effect of Insulin Degludec in Combination With Liraglutide and Metformin in Subjects With Type 2 Diabetes Qualifying for Treatment Intensification

summary: This trial is conducted in Africa, Asia, Europe and North America. The purpose of the trial is to investigate the effect of insulin degludec (IDeg) in combination with liraglutide (Lira) and metformin (at least 1500 mg daily or maximum tolerated dose) in subjects with type 2 diabetes qualifying for treatment intensification.

ReferenceCitation: Aroda VR, Bailey TS, Cariou B, Kumar S, Leiter LA, Raskin P, Zacho J, Andersen TH, Philis-Tsimikas A. Effect of adding insulin degludec to treatment in patients with type 2 diabetes inadequately controlled with metformin and liraglutide: a double-blind randomized controlled trial (BEGIN: ADD TO GLP-1 Study). Diabetes Obes Metab. 2016 Jul;18(7):663-70. doi: 10.1111/dom.12661. Epub 2016 May 2. Erratum in: Diabetes Obes Metab. 2016 Sep;18(9):952.

lead_sponsor: Novo Nordisk A/S

location_country:
Serbia
United Kingdom
Italy
Canada
Ukraine
United States
Israel
France
South Africa
Germany
United Arab Emirates


title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With 5-Fluorouracil, Folinic Acid, and Oxaliplatin (mFOLFOX6) in Patients With Metastatic HER2-Negative, MET-Positive Gastroesophageal Cancer

summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with 5-fluorouracil, folinic Acid, and oxaliplatin (mFOLFOX6) in participants with metastatic human epidermal growth receptor (HER) 2-negative and MET-positive adenocarcinoma of the stomach or gastroesophageal junction. Participants will be randomized in a 1:1 ratio to receive either onartuzumab or placebo in combination with mFOLFOX6. Participants may continue to receive onartuzumab or placebo until disease progression, unacceptable toxicity, participant or physician decision to discontinue treatment.

ReferenceCitation: Shah MA, Bang YJ, Lordick F, Alsina M, Chen M, Hack SP, Bruey JM, Smith D, McCaffery I, Shames DS, Phan S, Cunningham D. Effect of Fluorouracil, Leucovorin, and Oxaliplatin With or Without Onartuzumab in HER2-Negative, MET-Positive Gastroesophageal Adenocarcinoma: The METGastric Randomized Clinical Trial. JAMA Oncol. 2017 May 1;3(5):620-627. doi: 10.1001/jamaoncol.2016.5580.

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Hong Kong
Russian Federation
Australia
Israel
Panama
Turkey
Mexico
Malaysia
Singapore
Canada
Switzerland
Guatemala
Germany
Taiwan
Czech Republic
Thailand
Korea, Republic of
France


title: A Phase III Randomized, Double Blind, Placebo Controlled Study of BKM120 With Fulvestrant, in Postmenopausal Women With Hormone Receptor-positive HER2-negative AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTOR Inhibitor Based Treatment

summary:
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs. Placebo plus Fulvestrant in postmenopausal women with hormone Receptor-positive (HR-positive), human epidermal growth factor receptor 2-negative (HER2-negative), aromatase inhibitor (AI)-treated, locally advanced or metastatic breast cancer whose disease progressed on or after mammalian target of rapamycin inhibitor (mTORi)-based treatment.

Patients were randomized in 2:1 ratio to treatment with buparlisib 100 mg daily in combination with fulvestrant 500 mg or placebo daily in combination with fulvestrant 500 mg. Randomization was stratified according to visceral disease status (present or absent).

status: Terminated

ReferenceCitation: Di Leo A, Johnston S, Lee KS, Ciruelos E, Lønning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csőszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7. Erratum in: Lancet Oncol. 2018 Mar;19(3):e137.

ipd_sharing: Undecided

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Spain
Italy
United Kingdom
United States
Belgium
Poland
Austria
Argentina
Norway
Sweden
Lebanon
Canada
Hungary
Germany
Bulgaria
Greece
Finland
Thailand
Korea, Republic of
France
Colombia
Netherlands

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC

location_facility: Lsu Health Sciences Center/ Lsu School of Medicine Lsu

location_facility: Texas Tech University Health Science Center Dept of Texas Tech

location_facility: Compassionate Cancer Care Medical Group CCCMG

location_facility: University of South Alabama / Mitchell Cancer Institute Univ South AL

location_facility: CINJ at Cooper University Hospital Dept of Onc

location_facility: University of California at Los Angeles UCLA SC

location_facility: The West Clinic Dept. of the West Clinic

location_facility: Texas Oncology P A Texas Oncology - Fort Worth (3

location_facility: University of Maryland Medical Center Univ Maryland

location_facility: University of Pittsburgh Cancer Institute Dept of Magee Women's Hospital

location_facility: John Ochsner Heart and Vascular Institute Clinical Trials Ochsner 2

location_facility: Morristown Memorial Hospital Morristown Mem

location_facility: Crescent City Research Consortium, LLC SC

location_facility: Los Angeles Hematology/Oncology Medical Group Onc Dept.

location_facility: Oregon Health and Science University SC-5

location_facility: LSU Health Sciences Center Feist-Weiller Cancer Center

location_facility: University of Texas Southwestern Medical Center

location_facility: Moanalua Medical Center. Attn: Oncology Dept

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: Emory University School of Medicine/Winship Cancer Institute Emory

status_simplified: Unknown


title: Adjuvant Axitinib Treatment of Renal Cancer: A Randomized Double-blind Phase 3 Study of Adjuvant Axitinib vs. Placebo in Subjects at High Risk of Recurrent RCC

acronym: ATLAS

summary: The purpose of this trial is to determine if adjuvant therapy with axitinib will prevent or delay the recurrence of renal cell cancer after surgery to remove the primary tumor in high risk patients.

primary_purpose: Prevention

ReferenceCitation: Gross-Goupil M, Kwon TG, Eto M, Ye D, Miyake H, Seo SI, Byun SS, Lee JL, Master V, Jin J, DeBenedetto R, Linke R, Casey M, Rosbrook B, Lechuga M, Valota O, Grande E, Quinn DI. Axitinib versus placebo as an adjuvant treatment of renal cell carcinoma: results from the phase III, randomized ATLAS trial. Ann Oncol. 2018 Dec 1;29(12):2371-2378. doi: 10.1093/annonc/mdy454.

lead_sponsor: SFJ Pharma Ltd. II

location_country:
Taiwan
Hong Kong
Spain
Korea, Republic of
India
United States
China
France
Japan


title: A Phase III, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma

acronym: COMBI-v

summary: This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.

ReferenceCitation: Schadendorf D, Robert C, Dummer R, Flaherty KT, Tawbi HA, Menzies AM, Banerjee H, Lau M, Long GV. Pyrexia in patients treated with dabrafenib plus trametinib across clinical trials in BRAF-mutant cancers. Eur J Cancer. 2021 Aug;153:234-241. doi: 10.1016/j.ejca.2021.05.005. Epub 2021 Jul 2.

ReferenceCitation: Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandalá M, Haanen JBAG, Lebbé C, Mackiewicz A, Rutkowski P, Nathan PD, Ribas A, Davies MA, Flaherty KT, Burgess P, Tan M, Gasal E, Voi M, Schadendorf D, Long GV. Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma. N Engl J Med. 2019 Aug 15;381(7):626-636. doi: 10.1056/NEJMoa1904059. Epub 2019 Jun 4.

ReferenceCitation: Long GV, Grob JJ, Nathan P, Ribas A, Robert C, Schadendorf D, Lane SR, Mak C, Legenne P, Flaherty KT, Davies MA. Factors predictive of response, disease progression, and overall survival after dabrafenib and trametinib combination treatment: a pooled analysis of individual patient data from randomised trials. Lancet Oncol. 2016 Dec;17(12):1743-1754. doi: 10.1016/S1470-2045(16)30578-2. Epub 2016 Nov 16.

ReferenceCitation: Grob JJ, Amonkar MM, Karaszewska B, Schachter J, Dummer R, Mackiewicz A, Stroyakovskiy D, Drucis K, Grange F, Chiarion-Sileni V, Rutkowski P, Lichinitser M, Levchenko E, Wolter P, Hauschild A, Long GV, Nathan P, Ribas A, Flaherty K, Sun P, Legos JJ, McDowell DO, Mookerjee B, Schadendorf D, Robert C. Comparison of dabrafenib and trametinib combination therapy with vemurafenib monotherapy on health-related quality of life in patients with unresectable or metastatic cutaneous BRAF Val600-mutation-positive melanoma (COMBI-v): results of a phase 3, open-label, randomised trial. Lancet Oncol. 2015 Oct;16(13):1389-98. doi: 10.1016/S1470-2045(15)00087-X.

ReferenceCitation: Robert C, Karaszewska B, Schachter J, Rutkowski P, Mackiewicz A, Stroiakovski D, Lichinitser M, Dummer R, Grange F, Mortier L, Chiarion-Sileni V, Drucis K, Krajsova I, Hauschild A, Lorigan P, Wolter P, Long GV, Flaherty K, Nathan P, Ribas A, Martin AM, Sun P, Crist W, Legos J, Rubin SD, Little SM, Schadendorf D. Improved overall survival in melanoma with combined dabrafenib and trametinib. N Engl J Med. 2015 Jan 1;372(1):30-9. doi: 10.1056/NEJMoa1412690. Epub 2014 Nov 16.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Israel
Norway
Sweden
Brazil
Canada
Switzerland
Hungary
Germany
Denmark
Taiwan
Ireland
New Zealand
Finland
Korea, Republic of
France
Netherlands


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of LY2439821 to Etanercept and Placebo in Patients With Moderate-to-Severe Plaque Psoriasis

summary: This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

ReferenceCitation: Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

ReferenceCitation: Rich P, Goldblum O, Disch D, Lin CY, Merola JF, Elewski B. Nail Psoriasis Does Not Affect Skin Response to Ixekizumab in Patients With Moderate-To-Severe Psoriasis. J Drugs Dermatol. 2020 Aug 1;19(8):741-746. doi: 10.36849/JDD.2020.5116.

ReferenceCitation: Leonardi C, Reich K, Foley P, Torii H, Gerdes S, Guenther L, Gooderham M, Ferris LK, Griffiths CEM, ElMaraghy H, Crane H, Patel H, Burge R, Gallo G, Shrom D, Leung A, Lin CY, Papp K. Efficacy and Safety of Ixekizumab Through 5 Years in Moderate-to-Severe Psoriasis: Long-Term Results from the UNCOVER-1 and UNCOVER-2 Phase-3 Randomized Controlled Trials. Dermatol Ther (Heidelb). 2020 Jun;10(3):431-447. doi: 10.1007/s13555-020-00367-x. Epub 2020 Mar 21.

ReferenceCitation: Yosipovitch G, Reich A, Steinhoff M, Beselin A, Kent T, Dossenbach M, Berggren L, Henneges C, Luger T. Impact of Ixekizumab Treatment on Itch and Psoriasis Area and Severity Index in Patients with Moderate-to-Severe Plaque Psoriasis: An Integrated Analysis of Two Phase III Randomized Studies. Dermatol Ther (Heidelb). 2018 Dec;8(4):621-637. doi: 10.1007/s13555-018-0267-9. Epub 2018 Nov 21. Review.

ReferenceCitation: Blauvelt A, Papp KA, Griffiths CEM, Puig L, Weisman J, Dutronc Y, Kerr LF, Ilo D, Mallbris L, Augustin M. Efficacy and Safety of Switching to Ixekizumab in Etanercept Non-Responders: A Subanalysis from Two Phase III Randomized Clinical Trials in Moderate-to-Severe Plaque Psoriasis (UNCOVER-2 and -3). Am J Clin Dermatol. 2017 Apr;18(2):273-280. doi: 10.1007/s40257-016-0246-9. Erratum in: Am J Clin Dermatol. 2018 Mar 29;:.

ReferenceCitation: Gordon KB, Blauvelt A, Papp KA, Langley RG, Luger T, Ohtsuki M, Reich K, Amato D, Ball SG, Braun DK, Cameron GS, Erickson J, Konrad RJ, Muram TM, Nickoloff BJ, Osuntokun OO, Secrest RJ, Zhao F, Mallbris L, Leonardi CL; UNCOVER-1 Study Group; UNCOVER-2 Study Group; UNCOVER-3 Study Group. Phase 3 Trials of Ixekizumab in Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2016 Jul 28;375(4):345-56. doi: 10.1056/NEJMoa1512711. Epub 2016 Jun 8.

ReferenceCitation: Armstrong AW, Lynde CW, McBride SR, Ståhle M, Edson-Heredia E, Zhu B, Amato D, Nikaï E, Yang FE, Gordon KB. Effect of Ixekizumab Treatment on Work Productivity for Patients With Moderate-to-Severe Plaque Psoriasis: Analysis of Results From 3 Randomized Phase 3 Clinical Trials. JAMA Dermatol. 2016 Jun 1;152(6):661-9. doi: 10.1001/jamadermatol.2016.0269.

ReferenceCitation: Griffiths CE, Reich K, Lebwohl M, van de Kerkhof P, Paul C, Menter A, Cameron GS, Erickson J, Zhang L, Secrest RJ, Ball S, Braun DK, Osuntokun OO, Heffernan MP, Nickoloff BJ, Papp K; UNCOVER-2 and UNCOVER-3 investigators. Comparison of ixekizumab with etanercept or placebo in moderate-to-severe psoriasis (UNCOVER-2 and UNCOVER-3): results from two phase 3 randomised trials. Lancet. 2015 Aug 8;386(9993):541-51. doi: 10.1016/S0140-6736(15)60125-8. Epub 2015 Jun 10.

ipd_sharing_description:
Plan Description:

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
Spain
United Kingdom
Austria
Australia
Netherlands
Canada
United States
France
Romania
Germany
Czechia

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.


title: REGISTRY - an Observational Study of the European Huntington's Disease Network (EHDN)

acronym: REGISTRY

summary:
This is a multi-centre, multi-national, prospective, observational study of Huntington's disease (HD) with a control group of volunteers to:

obtain natural history data on many HD mutation carriers and individuals who are part of an HD family
relate phenotypical characteristics (genetic modifiers / wet and dry biomarkers)
expedite identification and recruitment of participants for clinical trials
develop and validate sensitive and reliable outcome measures for detecting onset and change over the natural course of premanifest and manifest HD which may also be potential outcome measures for use in future clinical trials and clinical care
plan for future research studies

study_type: Observational

time_perspective: Other

ReferenceCitation: Rickards H, De Souza J, van Walsem M, van Duijn E, Simpson SA, Squitieri F, Landwehrmeyer B; European Huntington's Disease Network. Factor analysis of behavioural symptoms in Huntington's disease. J Neurol Neurosurg Psychiatry. 2011 Apr;82(4):411-2. doi: 10.1136/jnnp.2009.181149. Epub 2010 Apr 14.

ReferenceCitation: Orth M, Handley OJ, Schwenke C, Dunnett SB, Craufurd D, Ho AK, Wild E, Tabrizi SJ, Landwehrmeyer GB; Investigators of the European Huntington's Disease Network. Observing Huntington's Disease: the European Huntington's Disease Network's REGISTRY. Version 2. PLoS Curr. 2010 Sep 28 [revised 2011 Jan 1];2:RRN1184.

ReferenceCitation: Orth M; European Huntington's Disease Network, Handley OJ, Schwenke C, Dunnett S, Wild EJ, Tabrizi SJ, Landwehrmeyer GB. Observing Huntington's disease: the European Huntington's Disease Network's REGISTRY. J Neurol Neurosurg Psychiatry. 2011 Dec;82(12):1409-12. doi: 10.1136/jnnp.2010.209668. Epub 2010 Nov 19.

ReferenceCitation: Busse M, Al-Madfai DH, Kenkre J, Landwehrmeyer GB, Bentivoglio A, Rosser A; European Huntington's Disease Network. Utilisation of Healthcare and Associated Services in Huntington's disease: a data mining study. PLoS Curr. 2011 Jan 21;3:RRN1206. doi: 10.1371/currents.RRN1206.

ReferenceCitation: López-Sendón JL, Royuela A, Trigo P, Orth M, Lange H, Reilmann R, Keylock J, Rickards H, Piacentini S, Squitieri F, Landwehrmeyer B, Witjes-Ane MN, Jurgens CK, Roos RA, Abraira V, de Yébenes JG; European HD Network. What is the impact of education on Huntington's disease? Mov Disord. 2011 Jul;26(8):1489-95. doi: 10.1002/mds.23385. Epub 2011 Mar 22.

ReferenceCitation: Ho AK, Hocaoglu MB; European Huntington's Disease Network Quality of Life Working Group. Impact of Huntington's across the entire disease spectrum: the phases and stages of disease from the patient perspective. Clin Genet. 2011 Sep;80(3):235-9. doi: 10.1111/j.1399-0004.2011.01748.x. Epub 2011 Aug 4.

ReferenceCitation: Quarrell OW, Handley O, O'Donovan K, Dumoulin C, Ramos-Arroyo M, Biunno I, Bauer P, Kline M, Landwehrmeyer GB; European Huntington's Disease Network. Discrepancies in reporting the CAG repeat lengths for Huntington's disease. Eur J Hum Genet. 2012 Jan;20(1):20-6. doi: 10.1038/ejhg.2011.136. Epub 2011 Aug 3.

ReferenceCitation: Saft C, Epplen JT, Wieczorek S, Landwehrmeyer GB, Roos RA, de Yebenes JG, Dose M, Tabrizi SJ, Craufurd D; REGISTRY Investigators of the European Huntington's Disease Network, Arning L. NMDA receptor gene variations as modifiers in Huntington disease: a replication study. PLoS Curr. 2011 Oct 4;3:RRN1247. doi: 10.1371/currents.RRN1247.

ReferenceCitation: Rickards H, De Souza J, Crooks J, van Walsem MR, van Duijn E, Landwehrmeyer B, Squitieri F, Simpson SA; European Huntington's Disease Network. Discriminant analysis of Beck Depression Inventory and Hamilton Rating Scale for Depression in Huntington's disease. J Neuropsychiatry Clin Neurosci. 2011 Fall;23(4):399-402. doi: 10.1176/jnp.23.4.jnp399.

ReferenceCitation: Lee JM, Ramos EM, Lee JH, Gillis T, Mysore JS, Hayden MR, Warby SC, Morrison P, Nance M, Ross CA, Margolis RL, Squitieri F, Orobello S, Di Donato S, Gomez-Tortosa E, Ayuso C, Suchowersky O, Trent RJ, McCusker E, Novelletto A, Frontali M, Jones R, Ashizawa T, Frank S, Saint-Hilaire MH, Hersch SM, Rosas HD, Lucente D, Harrison MB, Zanko A, Abramson RK, Marder K, Sequeiros J, Paulsen JS; PREDICT-HD study of the Huntington Study Group (HSG), Landwehrmeyer GB; REGISTRY study of the European Huntington's Disease Network, Myers RH; HD-MAPS Study Group, MacDonald ME, Gusella JF; COHORT study of the HSG. CAG repeat expansion in Huntington disease determines age at onset in a fully dominant fashion. Neurology. 2012 Mar 6;78(10):690-5. doi: 10.1212/WNL.0b013e318249f683. Epub 2012 Feb 8.

ReferenceCitation: Henley SM, Ridgway GR, Scahill RI, Klöppel S, Tabrizi SJ, Fox NC, Kassubek J; EHDN Imaging Working Group. Pitfalls in the use of voxel-based morphometry as a biomarker: examples from huntington disease. AJNR Am J Neuroradiol. 2010 Apr;31(4):711-9. doi: 10.3174/ajnr.A1939. Epub 2009 Dec 24.

ReferenceCitation: Aziz NA, Jurgens CK, Landwehrmeyer GB; EHDN Registry Study Group, van Roon-Mom WM, van Ommen GJ, Stijnen T, Roos RA. Normal and mutant HTT interact to affect clinical severity and progression in Huntington disease. Neurology. 2009 Oct 20;73(16):1280-5. doi: 10.1212/WNL.0b013e3181bd1121. Epub 2009 Sep 23. Erratum in: Neurology. 2009 Nov 10;73(19):1608. Neurology. 2011 Jan 11;76(2):202. Ciarmielo, Andrea [corrected to Ciarmiello, Andrea].

ReferenceCitation: Youssov K, Audureau E, Vandendriessche H, Morgado G, Layese R, Goizet C, Verny C, Bourhis ML, Bachoud-Lévi AC. The burden of Huntington's disease: A prospective longitudinal study of patient/caregiver pairs. Parkinsonism Relat Disord. 2022 Oct;103:77-84. doi: 10.1016/j.parkreldis.2022.08.023. Epub 2022 Aug 24.

ReferenceCitation: McAllister B, Gusella JF, Landwehrmeyer GB, Lee JM, MacDonald ME, Orth M, Rosser AE, Williams NM, Holmans P, Jones L, Massey TH; REGISTRY Investigators of the European Huntington's Disease Network. Timing and Impact of Psychiatric, Cognitive, and Motor Abnormalities in Huntington Disease. Neurology. 2021 May 11;96(19):e2395-e2406. doi: 10.1212/WNL.0000000000011893. Epub 2021 Mar 25.

ReferenceCitation: Cubo E, Ramos-Arroyo MA, Martinez-Horta S, Martínez-Descalls A, Calvo S, Gil-Polo C; European HD Network. Clinical manifestations of intermediate allele carriers in Huntington disease. Neurology. 2016 Aug 9;87(6):571-8. doi: 10.1212/WNL.0000000000002944. Epub 2016 Jul 8.

lead_sponsor: European Huntington's Disease Network

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
Netherlands
Russian Federation
Finland
United Kingdom
Switzerland
Sweden
France
Belgium
Norway
Germany
Czechia

location_facility: Azienda Ospedaliera S. Andrea, UOC Neurologia e Centro Neurologico Terapie Sperimentali CENTERS

location_facility: HU Clermont-Ferrand - Hôpital Gabriel Montpied, Service de Neurologie

location_facility: Southampton General Hospital and University of Southampton, Neurology / Wellcome Trust Clinical Research Facility

location_facility: Hôpital Purpan, INSERM U825, Pôle Neurosciences

location_facility: Medisch Spectrum Twente, Dept. of Neurology

location_facility: The Walton Centre for Neurology and Neurosurgery

location_facility: Specialistic Hospital in Gdansk, Dept. of Neurology

location_facility: University of Manchester, Genetic Medicine, St. Mary's Hospital

location_facility: Rikshospitalet, Dept. of Medical Genetics

location_facility: Hospital La Fe, Consultas Externas de Neurología

location_facility: Hospital de Santa Maria, Centro de Estudos Egas Moniz, Neurology Dept.

location_facility: Università di Bologna, Dip. di Scienze Neurologiche - Clinica Neurologica

location_facility: National Hospital for Neurology and Neurosurgery, Dept. for Neurology

location_facility: Cambridge Centre for Brain Repair, Forvie Site

location_facility: Charité - Universitätsmedizin Berlin, Klinik und Poliklinik für Neurologie, Klinik für Psychiatrie und Psychotherapie

location_facility: Hospital Geral de Santo António, Neurology Dept.

location_facility: Sahlgren University Hospital, Dept. of Clinical Genetics

location_facility: Oulu University Hospital (OUH), Dept. of Neurology

location_facility: Ninewells Hospital and Medical School, Human Genetics Unit

location_facility: Gloucestershire Royal Hospital, Neurology Dept.

location_facility: Centrum extrapyramidových onemocnění, Neurologická klinika, 1. LFUK

location_facility: Karolinska University Hospital - Huddinge Division, Neurology

location_facility: Turku University Hospital, Dept. of Neurology

location_facility: Hospital Universitario Mutua de Terrassa, Neurologia - Investigación

location_facility: Università di Genova, Dept. of Neurosciences

location_facility: Hospital Fernando Fonseca, Neurology Dept.

location_facility: University of Bari, Dept. of Neurological and Psychiatric Sciences

location_facility: The Finnish Parkinson Association, Suvituuli

location_facility: Helsinki University Hospital, Dept. of Neurology

location_facility: NKS Olaviken Alderpsykiatriske sykehus, Poliklinikk og Huntington Klinikk

location_facility: Hospital Virgen de la Arrixaca, Neurology

location_facility: The Barberry Centre, Dept. of Psychiatry

location_facility: Ulleval University Hospital, Medical Genetics

location_facility: University of Florence, Dip. di Scienze Neurologiche e Psichiatriche

location_facility: Reha-Zentrum Dinslaken im Gesundheitszentrum Lang, Tagesklinik

location_facility: Scottish Huntington Association, Units 105/106

location_facility: University Hospital Zurich, Dept. of Neurology

location_facility: Universitair Ziekenhuis Gasthuisberg, Dienst Neurologie

location_facility: Neurologische Klinik mit Klinischer Neurophysiologie, Medizinische Hochschule Hannover

location_facility: Technische Universität München, Abteilung Neurologie

location_facility: CHU d'Angers, Service de Neurologie Charcot

location_facility: University Hospital of Ulm, Dept. of Neurology

location_facility: Hospital dos Capuchos, Centro Hospitalar Lisboa Central, Neurology Dept.

location_facility: Universitätsklinikum Aachen, Neurologische Klinik

location_facility: Hospital Virgen del Camino, Medical Genetics

location_facility: CHU La Timone, Service de Neurologie (9e étage)

location_facility: Hôpital Henri Mondor, Service de Neurologie

location_facility: Institute of Human Genetics, International Centre for Life

location_facility: University Hospital of Copenhagen - Rigshospitalet, Dept. of Neurology

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust, Neurosciences Directorate, Royal Preston Hospital

location_facility: Neurologische Klinik des Inselspitals, Praxis

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta, I Neurologia

location_facility: Universitätsklinikum Münster, Klinik und Poliklinik für Neurologie

location_facility: Medical University of Silesia, Dept. of Neurology

location_facility: Cardiff University, Life Sciences Building

location_facility: Molecular Medicine Centre, Western General Hospital, Dept. of Clinical Genetics

location_facility: Hospital Vall d'Hebrón, Neurología, 3ª planta, consultas externas

location_facility: Ålands Hälso- och Sjukvård, Långvårdsenheten

location_facility: Norrlands Universitet Sjukhus, Dept. of Neurology

location_facility: Leiden University Medical Centre (LUMC), Neurology K5-Q

location_facility: CHUV - Centre Hospitalier Universitaire Vaudois, Département de Neurologie

location_facility: Churchill Hospital, Dept. of Clinical Genetics

location_facility: Institute of Psychiatry and Neurology, First Dept. of Neurology

location_facility: Derriford Hospital, Dept. of Clinical Neuropsychology

location_facility: Clinical Genetics Centre, Ground Floor, Ashgrove House

location_facility: Poznan University of Medical Sciences, Dept. of Social Medicine

location_facility: Poole Hospital Foundation Trust, Brain Injury Service

location_facility: CHU d'Amiens - Hôpital Nord, Service de Neurologie

location_facility: Azienda Ospedaliera Universitarie Pisana, Dip. di Neuroscienze - UO Neurologia

location_facility: Royal Devon and Exeter Foundation Trust Hospital, Department of Neurology

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden, Klinik und Poliklinik für Neurologie

location_facility: Hospital Universitario Virgen del Rocío, Servicio de Neurología

location_facility: Fakultní nemocnice Olomouc, Neurologická klinika

location_facility: Universitätsklinik für Psychiatrie, Neuropsychiatrische Ambulanz

location_facility: St George's Hospital Medical School, South West Thames Regional Genetics Unit

location_facility: Università Cattolica del Sacro Cuore "A.Gemelli", Istituto di Neurologia / CNR, Istituto di Farmacologia Traslazionale

location_facility: Universtität Erlangen, Abteilung für Molekulare Neurologie

location_facility: Università di Napoli Federico II, Dip. Scienze Neurologiche Edificio 17

location_facility: Complejo Hospitalario Universitario de Albacete, Neurología

location_facility: Institute of Pathology and Genetics (IPG)

location_facility: The Family Federation of Finland Väestöliitto, Department of Medical Genetics

location_facility: Hospital Donostia. Universidad del Pais Vasco, Neurociencias

location_facility: Hospital Clínico de Madrid, Servicio de Neurología

location_facility: Clinique Neurologique Hôpital Roger Salengro CHRU, Neurologie et Pathologie du Mouvement

location_facility: Hospital Clinico Universario, Department of Neurology

location_facility: Chapel Allerton Hospital, Yorkshire Regional Genetics Service

location_facility: Universitätsklinikum Hamburg-Eppendorf, Neurologische Abteilung

location_facility: Hôpital Pellegrin, Service de Génétique Médicale (ESF 3e étage)

location_facility: Hôpital La Pitié Salpétrière, Génétique & Inserm U679

location_facility: Medical University of Warsaw, Dept. of Neurology

location_facility: Leicestershire Partnership NHS Trust, EMD South School, OSL house

location_facility: Sheffield Children's Hospital, Dept. of Clinical Genetics

location_facility: Fondazione IRCCS Istituto Neruologico Carlo Besta, SOSD Genetics of Neurodegenerative and Metabolic Diseases

location_facility: CHU Rouen Charles Nicolle, Service de Neurologie

location_facility: Skåne Universitetssjukhus, Neurologiska kliniken

location_facility: Azienda Ospedaliera Spedali Civili di Brescia, Clinica Neurologica

location_facility: Hospital Clínic i Provincial, Neurología

location_facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, Neurology Dept.

location_facility: The Royal Hospital for Neuro-disability, Research and Development

location_facility: Isar-Amper-Klinikum - Klinik Taufkirchen (Vils)

location_facility: Bucknall Hospital, Neuropsychiatry Service


title: Enroll -HD: A Prospective Registry Study in a Global Huntington's Disease Cohort

summary: Enroll-HD is a longitudinal, observational, multinational study that integrates two former Huntington's disease (HD) registries-REGISTRY in Europe, and COHORT in North America and Australasia-while also expanding to include sites in Latin America. More than 20,000 participants have now enrolled into the study. With annual assessments and no end date, Enroll-HD has built a large and rich database of longitudinal clinical data and biospecimens that form the basis for studies developing tools and biomarkers for progression and prognosis, identifying clinically-relevant phenotypic characteristics, and establishing clearly defined endpoints for interventional studies. Periodic cuts of the database are now available to any interested researcher to use in their research - visit www.enroll-hd.org/for-researchers/access-data/ to learn more.

status: Recruiting

time_perspective: Prospective

enrollment_type: Anticipated

ReferenceCitation: Landwehrmeyer GB, Fitzer-Attas CJ, Giuliano JD, Gonçalves N, Anderson KE, Cardoso F, Ferreira JJ, Mestre TA, Stout JC, Sampaio C. Data Analytics from Enroll-HD, a Global Clinical Research Platform for Huntington's Disease. Mov Disord Clin Pract. 2016 Jun 22;4(2):212-224. doi: 10.1002/mdc3.12388. eCollection 2017 Mar-Apr.

lead_sponsor: CHDI Foundation, Inc.

location_country:
Denmark
Poland
Portugal
Spain
Colombia
Austria
Australia
Ireland
Argentina
Canada
Italy
Netherlands
New Zealand
Switzerland
United States
Chile
France
United Kingdom
Belgium
Germany

location_facility: New Zealand Brain Research Institute at University of Otago

location_facility: Institut du Cerveau et de la Moelle Epinière

location_facility: Instituto de Neurociencias Buenos Aires (INEBA)

location_facility: Hospital de Santa Maria / Instituto de Medicina Molecular

location_facility: Central Manchester University Hospitals NHS Foundation Trust

location_facility: University of Illinois College of Medicine at Rockford

location_facility: Sheffield Children's NHS Foundation Trust

location_facility: Università degli Studi di Genova (DINOGMI)

location_facility: Universidad de Antioquia, Grupo de Neurociencias

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta - Genetics

location_facility: The Neurosciences Unit - North Metropolitan Hospital

location_facility: Northumberland, Tyne & Wear NHS Foundation Trust of St. Nicholas Hospital

location_facility: University of Tennessee Health Science Center

location_facility: Guy's and St. Thomas's NHS Foundation Trust

location_facility: Rutgers, the State University of New Jersey

location_facility: Lille-Amiens - Huntington Disease Constituent site

location_facility: Birmingham and Solihull Mental Health NHS Foundation Trust

location_facility: Booth Gardner Parkinson's Care Center (Evergreen Health)

location_facility: Hôpital Henri Mondor, Centre d'Investigation Clinique

location_facility: Virginia Commonwealth University Parkinson's and Movement Disorders Center

location_facility: University of Calgary, Movement Disorders Program

location_facility: University of Texas Health Science Center

location_facility: Fundacion Clinic per a La Recerca Biomèdica

location_facility: University of Maryland School of Medicine

location_facility: Cenexel Rocky Mountain Clinical Research, LLC

location_facility: Institute of Psychiatry and Neurology, Warsaw

location_facility: Royal Devon and Exeter NHS Foundation Trust

location_facility: CHU Angers, Centre de Référence Maladies Neurogénétiques

location_facility: Institut de Pathologie et de Génétique (IPG)

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta - Neurology

location_facility: North Staffordshire Combined Healthcare NHS Trust

location_facility: Avon and Wiltshire Mental Health Partnership

location_facility: University of Melbourne, Royal Melbourne Hospital

location_facility: Bordeaux - Huntington Disease competencies center

location_facility: Emory University, Wesley Woods Health Center

location_facility: Hôpitaux Universitaires de Strasbourg Hôpital de Hautepierre-Service de Neurologie

location_facility: University Hospital Carl Gustav Carus Dresden

location_facility: University of California - San Francisco

location_facility: University of Alberta Hospital in Edmonton

location_facility: St. Joseph's Hospital and Medical Center

location_facility: University of California - Irvine Medical Center

location_facility: University of South Florida, HDSA Center of Excellence at USF

location_facility: IRCCS Istituto delle Scienze Neurologiche di Bologna

location_facility: Copernicus Podmiotem Leczniczym sp. z o.o.

location_facility: Hôpital Purpan, Centre d'Investigation Clinique


title: A Dolutegravir Open Label Protocol for HIV Infected, Adult and Adolescent Patients With Integrase Resistance

acronym: DEAP

summary: ING114916 is an open-label, multi-center, expanded access (EAP) study

design_allocation: Non-Randomized

lead_sponsor: ViiV Healthcare

location_country:
Poland
Brazil
Italy
Austria
Canada
United States
France
Belgium
Germany


title: A Randomized Double-Blind Phase III Study of Ipilimumab Administered at 3 mg/kg Versus at 10 mg /kg in Subjects With Previously Treated or Untreated Unresectable or Metastatic Melanoma

summary: The purpose of this study is to determine whether giving Ipilimumab at a dose of 10mg/kg will extend the lives of subjects with unresectable or metastatic melanoma more than giving Ipilimumab at a dose of 3 mg/kg

ReferenceCitation: Ascierto PA, Del Vecchio M, Mackiewicz A, Robert C, Chiarion-Sileni V, Arance A, Lebbé C, Svane IM, McNeil C, Rutkowski P, Loquai C, Mortier L, Hamid O, Bastholt L, Dreno B, Schadendorf D, Garbe C, Nyakas M, Grob JJ, Thomas L, Liszkay G, Smylie M, Hoeller C, Ferraresi V, Grange F, Gutzmer R, Pikiel J, Hosein F, Simsek B, Maio M. Overall survival at 5 years of follow-up in a phase III trial comparing ipilimumab 10 mg/kg with 3 mg/kg in patients with advanced melanoma. J Immunother Cancer. 2020 Jun;8(1). pii: e000391. doi: 10.1136/jitc-2019-000391. Erratum in: J Immunother Cancer. 2020 Jul;8(2):.

ReferenceCitation: Feng Y, Wang X, Suryawanshi S, Bello A, Roy A. Linking Tumor Growth Dynamics to Survival in Ipilimumab-Treated Patients With Advanced Melanoma Using Mixture Tumor Growth Dynamic Modeling. CPT Pharmacometrics Syst Pharmacol. 2019 Nov;8(11):825-834. doi: 10.1002/psp4.12454. Epub 2019 Aug 13.

ReferenceCitation: Ascierto PA, Del Vecchio M, Robert C, Mackiewicz A, Chiarion-Sileni V, Arance A, Lebbé C, Bastholt L, Hamid O, Rutkowski P, McNeil C, Garbe C, Loquai C, Dreno B, Thomas L, Grob JJ, Liszkay G, Nyakas M, Gutzmer R, Pikiel J, Grange F, Hoeller C, Ferraresi V, Smylie M, Schadendorf D, Mortier L, Svane IM, Hennicken D, Qureshi A, Maio M. Ipilimumab 10 mg/kg versus ipilimumab 3 mg/kg in patients with unresectable or metastatic melanoma: a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2017 May;18(5):611-622. doi: 10.1016/S1470-2045(17)30231-0. Epub 2017 Mar 27.

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Czechia
Poland
Austria
Australia
Argentina
Israel
Mexico
Norway
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
France
Netherlands

location_facility: The Angeles Clinic And Research Institute

location_facility: St. Luke's Cancer Center - Anderson Campus

intervention_type: Biological


title: A Multi-centre, Multinational, Open-labelled, Randomised, Parallel-Group Comparison of Insulin Detemir Plus Insulin Aspart With NPH Insulin Plus Human Soluble Insulin in Subjects With Type 1 Diabetes on a Basal-Bolus Regimen

summary: This trial is conducted in Europe and South America. The aim of this trial is to compare the glycaemic control of insulin detemir plus insulin aspart with that of insulin NPH plus human soluble insulin in subjects with type 1 diabetes on a basal/bolus regimen.

ReferenceCitation: Hermansen K, Fontaine P, Kukolja KK, Peterkova V, Leth G, Gall MA. Insulin analogues (insulin detemir and insulin aspart) versus traditional human insulins (NPH insulin and regular human insulin) in basal-bolus therapy for patients with type 1 diabetes. Diabetologia. 2004 Apr;47(4):622-9.

location_country: Macedonia, The Former Yugoslav Republic of


title: An Open-Label, Multicenter, Multinational Study to Assess the Effect of Long-Term Prolonged-Release Fampridine (BIIB041) 10 mg Twice Daily on Quality of Life as Reported by Subjects With Multiple Sclerosis

acronym: ENABLE

summary: The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine (BIIB041) 10 mg twice daily on the physical component scale (PCS) of the Short Form 36 Health Status Questionnaire (SF-36) as reported by treatment responders. The secondary objectives of this study are to compare the change in the PCS of the SF-36 between treatment responders and non-responders, to evaluate change from baseline in additional quality of life measures among treatment responders as well as changes from baseline in treatment responders versus non-responders and to assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.

ReferenceType: background

ReferenceCitation: Macdonell R, Nagels G, Laplaud DA, Pozzilli C, de Jong B, Martins da Silva A, Nicholas R, Lechner-Scott J, Gaebler JA, Agarwal S, Wang P, Yeh M, Hovenden M, Soelberg Sørensen P. Improved patient-reported health impact of multiple sclerosis: The ENABLE study of PR-fampridine. Mult Scler. 2016 Jun;22(7):944-54. doi: 10.1177/1352458515606809. Epub 2015 Oct 7.

lead_sponsor: Biogen

location_country:
Denmark
Portugal
United Kingdom
Italy
Australia
Netherlands
France
Belgium
Germany


title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Onartuzumab (Metmab) in Combination With Tarceva (Erlotinib) in Patients With Met Diagnostic-Positive Non-Small Cell Lung Cancer Who Have Received Standard Chemotherapy for Advanced/Metastatic Disease

summary: This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

ReferenceCitation: Koeppen H, Yu W, Zha J, Pandita A, Penuel E, Rangell L, Raja R, Mohan S, Patel R, Desai R, Fu L, Do A, Parab V, Xia X, Januario T, Louie SG, Filvaroff E, Shames DS, Wistuba I, Lipkind M, Huang J, Lazarov M, Ramakrishnan V, Amler L, Phan SC, Patel P, Peterson A, Yauch RL. Biomarker analyses from a placebo-controlled phase II study evaluating erlotinib±onartuzumab in advanced non-small cell lung cancer: MET expression levels are predictive of patient benefit. Clin Cancer Res. 2014 Sep 1;20(17):4488-98. doi: 10.1158/1078-0432.CCR-13-1836. Epub 2014 Mar 31.

lead_sponsor: Genentech, Inc.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Peru
Belgium
Japan
South Africa
Poland
Hong Kong
Russian Federation
Australia
Argentina
Israel
Brazil
Canada
Hungary
Germany
Taiwan
Ireland
Korea, Republic of
France
Chile
Netherlands