acronym: EMBRACA

lead_sponsor: Pfizer

summary: The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.

ReferenceCitation: Blum JL, Laird AD, Litton JK, Rugo HS, Ettl J, Hurvitz SA, Martin M, Roche HH, Lee KH, Goodwin A, Chen Y, Lanzalone S, Chelliserry J, Czibere A, Hopkins JF, Albacker LA, Mina LA. Determinants of Response to Talazoparib in Patients with HER2-Negative, Germline BRCA1/2-Mutated Breast Cancer. Clin Cancer Res. 2022 Apr 1;28(7):1383-1390. doi: 10.1158/1078-0432.CCR-21-2080.

evidence: oa repository (via page says license)

repositories_concat: PubMed Central;aacr.figshare.com

publisher_dissemination: American Association for Cancer Research

ReferenceCitation: Ettl J, Quek RGW, Lee KH, Rugo HS, Hurvitz S, Goncalves A, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roche H, Im YH, Markova D, Bhattacharyya H, Hannah AL, Eiermann W, Blum JL, Litton JK. Quality of life with talazoparib versus physician's choice of chemotherapy in patients with advanced breast cancer and germline BRCA1/2 mutation: patient-reported outcomes from the EMBRACA phase III trial. Ann Oncol. 2018 Sep 1;29(9):1939-1947. doi: 10.1093/annonc/mdy257.

ReferenceCitation: Litton JK, Rugo HS, Ettl J, Hurvitz SA, Goncalves A, Lee KH, Fehrenbacher L, Yerushalmi R, Mina LA, Martin M, Roche H, Im YH, Quek RGW, Markova D, Tudor IC, Hannah AL, Eiermann W, Blum JL. Talazoparib in Patients with Advanced Breast Cancer and a Germline BRCA Mutation. N Engl J Med. 2018 Aug 23;379(8):753-763. doi: 10.1056/NEJMoa1802905. Epub 2018 Aug 15.

sponsor_collaborators:
Pfizer
Medivation, Inc.

location_facility: Severance Hospital, Yonsei University Health System

location_facility: UCSF Helen Diller Comprehensive Cancer Centre - Precision Cancer Medicine Building

location_facility: Uniwersyteckie Centrum Kliniczne im. Prof. K. Gibinskiego Slaskiego Uniwersytetu

location_facility: Arizona Oncology Associates P.C. - NAHOA

location_facility: Texas Oncology-El Paso Cancer Treatment Center Gateway

location_facility: Lake Norman Hematology Oncology Specialists

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm. D.

location_facility: Cancer Care SA trading as Icon Pharmacy Adelaide

location_facility: Uniwersyteckie Centrum Kliniczne, Zaklad Medycyny Nuklearnej

location_facility: University Of Texas, Md Anderson Cancer Center

location_facility: Ballarat Oncology & Haematology Services Clinical Trials Unit

location_facility: Los Angeles Hematology Oncology Medical Group

location_facility: State Budgetary Institution of Healthcare "Republican Oncology dispensary"'

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: "University of Miami Hospital & Clinics,Sylvester Comprehensive Cancer Center/UMHC"

location_facility: Kaiser Permanente Medical Center (Radiology)

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Hospital Universitari Arnau de Vilanova de Lleida

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center

location_facility: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.

location_facility: Klinikum rechts der Isar, TUM, Frauenklinik und Poliklinik

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: UCLA Santa Monica Medical Center & Orthopaedic Hospital

location_facility: The Center for Cancer and Blood Disorders (Huguley)

location_facility: Sir Charles Gairdner Hospital Lung Institute Of Western Australia

location_facility: A.O.U. Pisana, DAI Oncologia, U.O. Oncologia Med. 2 Univ.

location_facility: The Center for Cancer and Blood Disorders

location_facility: Indiana University- Melvin and Bren Simon Cancer Center (IUSCC)

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Medizinisches Zentrum fur Hamatologie und Onkologie Munchen MVZ

location_facility: Hospital do Cancer de Barretos - Fundacao Pio XII

location_facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

location_facility: Sylvester Comprehensive Cancer Center Plantation

location_facility: Oncology Institute, Davidoff Center, Rabin Medical Center, Beilinson Campus

location_facility: UCSF - Helen Diller Family Comprehensive Cancer Center

location_facility: Oklahoma Cancer Specialists and Research Institute, LLC

location_facility: Kaiser Permanente Mission Bay Medical Center Lab Drawing Station

location_facility: The University of Kansas Cancer Center (Regulatory Office)

location_facility: Communal Institution "Krivorizhskiy Oncology Dispensary" of Dnipropetrovsk Regional Council

location_facility: Novant Health Presbyterian Medical Center

location_facility: Kliniken Essen-Mitte, Klinik für Senologie / Brustzentrum

location_facility: Hopitaux Universitaires de Strasbourg - Hopital Civil

location_facility: New York University Langone Medical Center

location_facility: Clinica de Pesquisas e Centro de Estudos em Oncologia Ginecologica e Mamária Ltda.

location_facility: CBCC Global Research, Inc. at Comprehensive Blood and Cancer Center

location_facility: Oddzial Onkologii Klinicznej, Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: S.S.D. Oncologia Medica Addarii - A.O.U. di Bologna - Policlinico Sant'Orsola-Malpighi

location_facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie, Oddzial w Gliwicach

location_facility: The Catholic University of Korea, Seoul St. Mary's Hospital

location_facility: Oncology Institute, Assuta Medical Center

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

location_facility: Sylvester Comprehensive Cancer Center Kendall

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Cancer Research UK, Department of Medical Oncology - The Christie NHS Foundation Trust

location_facility: Institut de Cancerologie de l'Ouest - Site Rene Gauducheau

location_facility: Texas Oncology-El Paso Cancer Treatment Center Grandview

location_facility: University of Maryland, Greenebaum Comprehensive Cancer Center

location_facility: Hospital Nuestra Senora de Sonsoles(Complejo Asistencial de Avila)

location_facility: Hospital Universitari Germans Trias i Pujol

location_facility: Uniwersyteckie Centrum Kliniczne, Zaklad Radiologii

location_facility: Hospital da Cidade de Passo Fundo - HCPF

location_facility: US Oncology Investigational Products Center(IPC)

location_facility: Kaiser Permanente Medical Center Lab Drawing Station

location_facility: Sylvester Comprehensive Cancer Center Deerfield Beach

location_facility: University of Colorado Cancer Center - Anschutz Cancer Pavilion (ACP)

location_facility: Universitaetsklinikum Freiburg, Klinik fuer Frauenheilunde

location_facility: Barwon Health, University Hospital Geelong

location_facility: Ballarat Oncology & Haematology Services

location_facility: US Oncology Investigational Products Center (IPC)

location_facility: ICON Cancer Care (Haematology And Oncology Clinics Of Australasia (Hoca))-Milton

location_facility: A.S.S.T. Monza, Oncologia Medica, Ospedale San Gerardo

location_facility: Regional Municipal Institution "Sumy Regional Clinical Oncology Dispensary", Thoracic Department

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong, Pharm.D.

location_facility: St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare

location_facility: Drug Management Only: UCLA West Medical Pharmacy, Attn:Steven L. Wong, Pharm.D.

location_facility: Uniwersyteckie Centrum Kliniczne Klinika Onkologii i Radioterapii

location_facility: Hospital do Cancer III - INCA / Instituto Nacional do Cancer / MS INCA HCIII

location_facility: Centro de Referencia da Saude da Mulher - Hospital Perola Byington

location_facility: Seoul National University Bundang Hospital

location_facility: Novant Health Huntersville Medical Center

location_facility: Kaiser Permanente Medical Center (clinic+DSL)

location_facility: Nottingham University Hospital NHS Trust

location_facility: Instituto de Oncologia de Piracicaba S/S Ltda.

location_facility: Senologia Medica, IRCCS-Instituto Oncologico Europeo (IEO)

location_facility: University of Pittsburgh Medical Center, William M. Cooper Pavilion, Hillman Cancer Center

location_facility: Division of Oncology Tel Aviv Sourasky Medical Center

location_facility: Europejskie Centrum Zdrowia Otwock Szpital im.F.Chopina

location_facility: Institut Universitaire du Cancer Toulouse - Oncopole

location_facility: Royal Sussex County Hospital, Royal Alexandra Children's Hospital L10

location_facility: NU-MED Centrum Diagnostyki i Terapii Onkologicznej Katowice

location_facility: Regulatory Managment Only: TRIO-US Central Administration

location_facility: Instituto Nacional do Cancer Jose de Alencar Gomes da Silva

location_facility: Wielkopolskie Centrum Onkologii im. Marii Sklodowskiej-Curie

location_facility: Southern California Permanente Medical Group

location_facility: Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Pozna

location_facility: Pracownia Medycyny Nuklearnej, 109 Szpital Wojskowy z Przychodnia SP ZOZ

location_facility: Cancer And Hematology Centers Of Western Michigan

location_facility: Central Coast Medical Oncology Corporation

location_facility: Central de Quimioterapia Hospital do Cancer-INCA-HCIII

location_facility: US Oncology Investigational Product Center (IPC)

location_facility: Praxisklinik Krebsheilkunde fuer Frauen/Brustzentrum

location_facility: Austin Health, Heidelberg Repatriation Hospital (radiology (MUGA)scans only)

location_facility: Drug Management only: UCLA West Medical Pharmacy

location_facility: UCLA West Medical Pharmacy, Attn: Steven L. Wong

location_facility: Peninsula & South Eastern Haematology and Oncology Group

location_facility: Klinika Onkologii, Wojskowy lnstytut Medyczny

location_facility: Torrance Health Association, DBA Torrance Memorial Physician Network/Cancer care Associates

location_facility: Weill Cornell Medical College - New York-Presbyterian Hospital

location_facility: Pacific Central Coast Health Centers - San Luis Obispo Oncology and Hematology Health Center

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Uniao Brasileira de Educacao E Assistencia

location_facility: Weill Cornell Medical College - New York Presbyterian Hospital

location_facility: Pracownia Tomografii Komputerowej , Samodzielny Publiczny Szpital Kliniczny Nr 2 PUM w Szczecinie

location_facility: Northwest Cancer Specialists, P.C.(Admin Only)

location_facility: Universita Campus Bio-Medico di Roma, Dipartimento Oncologia Medica

location_facility: University of Munich (LMU), Grosshadern Hospital

location_facility: Oncology Institute, Rambam Health Care Campus

location_facility: Kyungpook National University Chilgok Hospital

location_facility: UCLA Hematology/Oncology - Santa Clarita

location_facility: Los Angeles Hematology Oncolgy Medical Group

location_facility: The University of Kansas Cancer Center - Investigational Drug Services

location_facility: Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie Klinika Nowotworow Piersi i

location_facility: La Maddalena Clinic For Cancer University Of Palermo

location_facility: The West Clinic, P.C. d/b/a West Cancer Center

location_facility: Texas Oncology - El Paso Cancer Treatment Center Joe Battle

title: A PHASE 3, OPEN-LABEL, RANDOMIZED PARALLEL,2-ARM,MULTI-CENTER STUDY OF TALAZOPARIB(BMN 673) VERSUS PHYSICIAN'S CHOICE IN GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER, WHO HAVE RECEIVED PRIOR CHEMOTHERAPY REGIMENS FOR METASTATIC DISEASE

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

location_country:
Germany
Ireland
Italy
Poland
Israel
United Kingdom
Australia
Brazil
Belgium
United States
Korea, Republic of
Spain
Taiwan
Ukraine
Russian Federation
France


title: A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Lucentis® Compared to Lucentis® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

summary: The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with Lucentis® compared to Lucentis® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

status: Terminated

study_completion_date_type: Actual

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.

oa_host_type: publisher

evidence: open (via free pdf)

host_type: publisher

license_normalized: no license

version: publishedVersion

repositories_concat: closed

unpaywall_oa_status: bronze

publisher_dissemination: Informa

ipd_sharing: No

ipd_sharing_description: There is no plan to share individual participant data at this time

lead_sponsor: Ophthotech Corporation

location_country:
Germany
Colombia
Hungary
Argentina
Denmark
Australia
Israel
United States
Spain
Turkey
France

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Unknown


title: A Phase 3 Randomized, Double-masked, Controlled Trial to Establish the Safety and Efficacy of Intravitreous Administration of Fovista® (Anti PDGF-B Pegylated Aptamer) Administered in Combination With Either Avastin® or Eylea® Compared to Avastin® or Eylea® Monotherapy in Subjects With Subfoveal Neovascular Age-related Macular Degeneration.

summary: The objectives of this study are to evaluate the safety and efficacy of intravitreal administration of Fovista® administered in combination with either Avastin® or Eylea® compared to Avastin® or Eylea® monotherapy in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).

study_start_date_type: Actual

ipd_sharing_description: There is no plan to share individual participant data at this time.

location_country:
Finland
Germany
Poland
Argentina
Australia
Brazil
Croatia
Czechia
Canada
France
Colombia
Portugal
Slovakia
Hungary
United States
Latvia
Estonia
Italy
Norway
Austria
Spain
Israel


title: A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation

summary: The purpose of this study is to evaluate the efficacy and safety of long-term treatment with lumacaftor in combination with ivacaftor in people 12 years and older with Cystic Fibrosis.

status: Completed

ReferenceCitation: Southern KW, Murphy J, Sinha IP, Nevitt SJ. Corrector therapies (with or without potentiators) for people with cystic fibrosis with class II CFTR gene variants (most commonly F508del). Cochrane Database Syst Rev. 2020 Dec 17;12(12):CD010966. doi: 10.1002/14651858.CD010966.pub3.

oa_host_type: repository

evidence: oa repository (via pmcid lookup)

host_type: repository

repository_normalized: PubMed Central

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Wiley

ReferenceCitation: Konstan MW, McKone EF, Moss RB, Marigowda G, Tian S, Waltz D, Huang X, Lubarsky B, Rubin J, Millar SJ, Pasta DJ, Mayer-Hamblett N, Goss CH, Morgan W, Sawicki GS. Assessment of safety and efficacy of long-term treatment with combination lumacaftor and ivacaftor therapy in patients with cystic fibrosis homozygous for the F508del-CFTR mutation (PROGRESS): a phase 3, extension study. Lancet Respir Med. 2017 Feb;5(2):107-118. doi: 10.1016/S2213-2600(16)30427-1. Epub 2016 Dec 21.

oa_host_type: closed

publisher_dissemination: Elsevier

lead_sponsor: Vertex Pharmaceuticals Incorporated

location_country:
France
Germany
Ireland
Italy
United Kingdom
Denmark
Australia
Sweden
Netherlands
Austria
Belgium
United States
Spain
Canada
Czech Republic

status_simplified: Completed


type: Other Identifier

title: Effect of Passive Immunization on the Progression of Mild Alzheimer's Disease: Solanezumab (LY2062430) Versus Placebo

acronym: EXPEDITION 3

summary: To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD) as compared with placebo in participants with mild AD.

ReferenceCitation: Honig LS, Vellas B, Woodward M, Boada M, Bullock R, Borrie M, Hager K, Andreasen N, Scarpini E, Liu-Seifert H, Case M, Dean RA, Hake A, Sundell K, Poole Hoffmann V, Carlson C, Khanna R, Mintun M, DeMattos R, Selzler KJ, Siemers E. Trial of Solanezumab for Mild Dementia Due to Alzheimer's Disease. N Engl J Med. 2018 Jan 25;378(4):321-330. doi: 10.1056/NEJMoa1705971.

oa_colors: green other

oa_host_type: publisher;repository

evidence: open (via free article)

evidence: oa repository (via OAI-PMH doi match)

repository_institution: Indiana University - Purdue University Indianapolis - IUPUI ScholarWorks

publisher_dissemination: Massachusetts Medical Society

ipd_sharing: Yes

ipd_sharing_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:
Germany
Italy
Poland
United Kingdom
Australia
Japan
Sweden
United States
Spain
Canada
France

location_facility: Drexel University College of Medicine at EPPI

location_facility: Veterans Affairs Puget Sound Health Care System

location_facility: Quillen College of Medicine, East TN State University

location_facility: Jacksonville Center for Clinical Research

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: University of Texas Southwestern Medical Center at Dallas

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.

location_facility: National Clinical Research - Norfolk Inc

location_facility: ANI Arizona Neurological Institute Research, PC

location_facility: American Neuropsychiatric Research Institute, Inc

location_facility: Parkinson's Disease and Movement Disorders

location_facility: Premiere Research Institute at Palm Beach Neurology

location_facility: Miami Jewish Home and Hospital for the Aged

location_facility: Institute for Neurodegenerative Disorders

location_facility: University Psychiatry Associates Avera Health

location_facility: Associated Neurologists of Southern Connecticut

location_facility: Vanderbilt Univeristy School of Medicine

location_facility: Neuropsychiatric Research Center of Southwest Florida

location_facility: University of California, Davis - Health Systems

location_facility: Institute for Memory Impairment & Neurological Disorders

location_facility: Collaborative Neuroscience Network - CNS

location_facility: Univ of Southern California Medical Center

location_facility: University of California Los Angeles School of Medicine


acronym: RA-BEYOND

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.

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.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

evidence: oa repository (via OAI-PMH title and first author match)

repository_institution: University of Oxford - Oxford University Research Archive (ORA)

repositories_concat: PubMed Central;ora.ox.ac.uk

unpaywall_oa_status: hybrid

publisher_dissemination: British Medical Journal

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.

oa_colors: green gold

evidence: oa journal (via doaj)

unpaywall_oa_status: gold

publisher_dissemination: Springer-Nature

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.

repository_institution: PubMed Central - Europe PMC

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.

license: cc-by

license_normalized: cc-by

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.

repository_institution: University of Leeds, The University of Sheffield, University of York - White Rose Research Online

repository_institution: The University of Glasgow - Enlighten: Publications

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.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

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

location_facility: Rheumatology Associates of Central Florida

location_facility: Tsuzuki Azuma Clinic: Primary care and Rheumatology

location_facility: Instituto Medico de Alta Complejidad San Isidro

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

location_facility: First Affiliated Hospital of Kunming Medical University

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: CHUV Centre Hospitalier Universitaire Vaudois

location_facility: Allergy Asthma Immunology of Rochester, AAIR Research Ctr

location_facility: Mexico Centre for Clinical Research SA de CV

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

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

location_facility: Kondo Clinic for Rheumatism and Orthopaedics

location_facility: Asheville Rheumatology & Osteoporosis Research Assoc, PA

location_facility: Ryazan Regional Clinincal Cardiology Dispensary

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

location_facility: Cent Priva Especiali Médicas Ambulatorias Inve Clin CEMAIC

location_facility: Xiangya Hospital, Central South University

location_facility: Orszagos Reumatologiai es Fizioterapias Intezet

location_facility: Arthritis and Osteoporosis Consultants of the Carolinas

location_facility: Spital Clinic Judetean de Urgenta Tg.Mures

location_facility: The Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Arthritis and Osteporosis Treatment and Research Center

location_facility: Inland Rheumatology & Osteoporosis Medical Group

location_facility: Associacao de Assistencia a Crianca Deficiente (AACD)

location_facility: CEPIC - Centro Paulista de Investigação Clínica

location_facility: Komagamine Orthopedic and Rheumatology Clinic

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: Daegu Catholic University Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: KLES Prabhakar Kore Hospital and Medical Research Centre

location_facility: The First Affiliate Hospital of AnHui Medical University

location_facility: Hospital Universitario Marques De Valdecilla

location_facility: Hôpital Arnaud de Villeneuve - CHU Montpellier

location_facility: Basingstoke and North Hampshire Hospital

location_facility: University of Occupational and Enviromental Health

location_facility: Allergy and Rheumatology Medical Clinic Inc

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

location_facility: Hokkaido Medical Center for Rheumatic Diseases

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

location_facility: Clinical Emergency Hospital N.V.Solovyov

location_facility: Centro de Enfermedades del Higado y Aparato Digestivo

location_facility: Nagasaki Medical Hospital of Rheumatology

location_facility: Instituto de Investigaciones Clínicas Mar del Plata

location_facility: West Broward Rheumatology Associates, Inc

location_facility: Center for Arthritis and Rheumatic Diseases, PC

location_facility: Manipal Centre for Clinical Research (MCCR)

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Krishna Institute of Medical Sciences Ltd.

location_facility: Centro de Medicina Familiar Mindout Research

location_facility: Kyunghee University Hospital at Gangdong

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

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

location_facility: St Marianna University School of Medicine Hospital

location_facility: Unidad de Investigacion en Enfermedades Cronico Degenerative

location_facility: CIR Centro de Investigacions Reumatologicas

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Immunologisches Zentrum Vogelsang-Gommern GmbH

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

location_facility: Yoshitama Clinic Rheumatology & Internal Medicine

location_facility: Okayama Saiseikai General Hospital Outpatient Center

location_facility: Consultorios Asociados de Endocrinologia

location_facility: Yoshida Orthopaedic and Rheumatic Clinic

location_facility: Shizuoka Rheumatism orthopedic Rehabilitation Hospital

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

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

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

location_facility: Instituto de Investigaciones Clinicas Quilmes

location_facility: Tokyo Women's Medical University East Medical Center

location_facility: Organizacion Medica de Investigacion - OMI

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

location_facility: Carolina Rheumatology and Neurology Associates

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

location_facility: Pauls Stradins Kliniska Universitates Slimnica

location_facility: Hospital Universitario La Fe de Valencia

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Centro de Investigaciones Medicas Mar del Plata

location_facility: Hospital Privado Centro Medico de Cordoba SA

location_facility: JA-Shizuoka Shizuoka-Kosei General Hospital

location_facility: (AOA) Arthritis & Osteoporosis Associates

location_facility: Afflilated Hospital of Bengbu Medical College

location_facility: Reumatologiska Kliniken Skånes universitetssjukhus Malmö

location_facility: Shri Nidan Hospital & Hope Fertility Centre

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

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

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

location_facility: CENIT Centro de Neurociencias, Investigación y Tratamiento

location_facility: University General Hospital of Heraklion

location_facility: The Second Xiangya Hospital of Central South University

location_facility: Niagara Peninsula Arthritis Centre, Inc.

location_facility: Centro Integral en Reumatologia SA de CV

location_facility: V.A. Nasonova Research Institute of Rheumatology

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

location_facility: Rheumatology Practice in Jaunliepaja Primary Health Care Cen

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

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


acronym: METEOR

lead_sponsor: Exelixis

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.

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.

version: acceptedVersion

version: submittedVersion

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, Grullich 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.

evidence: open (via crossref license)

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: University of Southern Denmark - University of Southern Denmark Research Portal

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.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

ReferenceCitation: Escudier B, Powles T, Motzer RJ, Olencki T, Aren 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, Geczi 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.

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

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


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).

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.

publisher_dissemination: Oxford University Press

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.

publisher_dissemination: Future Science Ltd

lead_sponsor: Hoffmann-La Roche

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

location_facility: Ospedale Bellaria; U.O. Oncologia Medica

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: Hospital Universitario Infanta Cristina; Servicio de Oncologia

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

location_facility: Centre Georges Francois Leclerc; Oncologie 3

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

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Hopital Roger Salengro; Service de Neurologie

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

location_facility: University College Hospital; Department of Oncology

location_facility: Papageorgiou General Hospital; Medical Oncology

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

location_facility: Hospital Universitario Son Espases; Servicio de Oncologia

location_facility: Institut Oncologic Ion Chiricuta; Departament Radioterapie

location_facility: Norrlands Universitetssjukhus; Cancer Centrum

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Hospital de Sao Joao; Servico de Oncologia

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

location_facility: Hospital de Cruces; Servicio de Oncologia

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

location_facility: Hopital Cote De Nacre; Unite Neurologie Generale

location_facility: Agioi Anargyroi Anticancer Hospital; Radiotherapeutic Clinic

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

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

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: Hospital Universitario La Paz; Servicio de Oncologia

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

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

location_facility: Tom Baker Cancer Centre; Dept of Medicine

location_facility: McGill University; Montreal Neurological Institute; Oncology

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Oncologia

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

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

location_facility: Royal Marsden Hospital; Dept of Medical Oncology

location_facility: Hospital Clinico Universitario de Salamanca; Servicio de Oncologia

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

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

location_facility: Hospital Universitario Reina Sofia; Servicio de Oncologia

location_facility: Medizinische Universität Graz; Universitätsklinik für Neurologie

location_facility: Kocaeli University Faculty of Medicine; Medical oncology

location_facility: IFO - Istituto Regina Elena; Oncologia Medica

location_facility: Hôpital Central; Departement de Neuro-Oncologie

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

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

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


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 beta2 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.

repository_institution: University of Ferrara - Institutional Research Information System University of Ferrara

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Diderot

repository_normalized: HAL

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - memSIC

repository_institution: Le Centre pour la Communication Scientifique Directe - HAL - Inria

repositories:
HAL
PubMed Central
iris.unife.it

repositories_concat: HAL;PubMed Central;iris.unife.it

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.

repository_institution: Washington University School of Medicine - Digital Commons@Becker

repository_institution: Ghent University - Ghent University Academic Bibliography

repositories_institution: University of Oxford - Oxford University Research Archive (ORA)

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. No abstract available.

ReferenceCitation: Corren J, Castro M, Chanez P, Fabbri L, Joish VN, Amin N, Graham NMH, Mastey V, Abbe 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.

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

location_facility:
Investigational Site Number 032007
Investigational Site Number 410004
Investigational Site Number 840028
Investigational Site Number 380010
Investigational Site Number 484004
Investigational Site Number 392025
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lead_sponsor: Bristol-Myers Squibb

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.

location_facility: University of Iowa Health Care (PI Address)

location_facility: University Hospitals Cleveland Medical Center

location_facility: Vanderbilt University Medical Center- GI Research Office

location_facility: Providence Sacred Heart Medical Center and Childrens Hospital

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

location_facility: Medical University of South Carolina, SCTR Research Nexus

location_facility: Virginia Commonwealth University Medical Center

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

location_facility: East Carolina Univ Nephrology Clin Res. Lab

location_facility: RUSH University Transplant Program (PI Address)

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

location_facility: Transplant Research Institute (PI Address)

location_facility: Medical College of Georgia at Augusta University

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

location_facility: Florida Hospital Transplant Institute (PI Address)

location_facility: Tulane University Health Sciences Center

location_facility: Medical College of WI Froedtert Hospital

location_facility: Methodist University Hospital Transplant Institute (PI Address)

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

location_facility: Baylor All Saints Medical Center at Ft. Worth

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

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

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

location_facility: University of Colorado Denver (PI Address)

location_facility: University of Virginia Health System (PI Address)

location_facility: Recanati/Miller Transplantation Institue (PI Address)

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

source: euctr

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


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.

repository_institution: University of Groningen / Centre for Information Technology - University of Groningen research database

license: cc-by-nc-sa

license_normalized: cc-by-nc-sa

repository_institution: University of Illinois at Chicago - INDIGO

repositories_concat: PubMed Central;figshare.com;pure.rug.nl

publisher_dissemination: American Diabetes Association

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.

publisher_dissemination: American Medical Association

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.

publisher_dissemination: Wolters Kluwer Health

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.

repository_institution: La Trobe University - OPAL (Open@LaTrobe)

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, Spinar 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.

repository_institution: DANS - Data Archiving and Networked Services - NARCIS - National Academic Research and Collaborations Information System

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, Smahelova 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. doi: 10.1016/j.jash.2016.01.001. No abstract available.

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.

sponsor_collaborators:
AstraZeneca
Bristol-Myers Squibb
The TIMI Study Group
Hadassah Medical Organization

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


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.

ReferenceCitation: Ascierto PA, Lewis KD, Di Giacomo AM, Demidov L, Mandala 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, BRAFv600 mutation-positive melanoma receiving adjuvant vemurafenib. Ann Oncol. 2020 Jan;31(1):153-159. doi: 10.1016/j.annonc.2019.10.002.

license: elsevier-specific: oa user license

license_normalized: elsevier-specific

ReferenceCitation: Maio M, Lewis K, Demidov L, Mandala 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, BRAFV600 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_facility: Hadassah University Hospital - Ein Kerem

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: Peninsula Oncology Centre; Frankston Private

location_facility: Institut Catala d Oncologia Hospital Duran i Reynals

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Clinical Hospital Center Sestre Milosrdnice

location_facility: Mcgill University - Royal Victoria Hospital; Oncology

location_facility: Tartu University Hospital; Clinic of Hematology and Oncology

location_facility: Centro Regiomontano de Investigación Clínica

location_facility: Istituto Nazionale Tumori Fondazione G. Pascale

location_facility: IDI-Istituto Dermopatico dell'Immacolata IRCCS

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

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

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

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

location_facility: University of Pennsylvania Health System

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Hospital Costa del Sol; Servicio de Oncologia

location_facility: Groupe Hospitalier Saint André - Hôpital Saint André

location_facility: Stavanger Universitetssykehus, Helse Stavanger HF

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

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata

location_facility: Institute of Oncology and Radiology of Serbia

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

location_facility: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke

location_facility: Hospital de Santa Maria; Servico de Oncologia Medica

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

location_facility: LHSC - Victoria Hospital; Department of Pediatrics

location_facility: St. Mary's Hospital Regional Cancer Center

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

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

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

location_facility: IRCCS Istituto Clinico Humanitas; Farmacia

location_facility: Clinica de Oncologia de Porto Alegre - CliniOnco

location_facility: CHU de Rouen Hopital; Service de Neurologie

location_facility: Klinikum Mannheim GmbH Universitätsklinikum

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

location_facility: The Ottawa Hospital Cancer Center; General Campus

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

location_facility: University of Pretoria Oncology Department

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

location_facility: Hospital Universitari i Politecnic La Fe

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

location_facility: East Tallinn Central Hospital; Clinic of Internal Medicine

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

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

location_facility: Hospital Clinico Universitario de Santiago

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

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

location_facility: IPO de Coimbra; Servico de Oncologia Medica

location_facility: IPO do Porto; Servico de Oncologia Medica

location_facility: University of Kansas Medical Center; Cancer Center

location_facility: Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory

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

location_facility: Leids Universitair Medisch Centrum; Cardiology

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

location_facility: The Townsville Hospital; Townsville Cancer Centre

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

location_facility: Princess Margaret Hospital; Department of Med Oncology

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

location_facility: Duke University Medical Center; Oncology

location_facility: Kaiser Permanente Sacramento Medical Center

location_facility: Launceston General Hospital; Gastroenterology Research

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

location_facility: Hospital Civil de Guadalajara Fray Antonio Alcalde

location_facility: Indiana University Health; Goshen Center for Cancer Care

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

location_facility: Istituto Nazionale per la Ricerca sul Cancro di Genova

location_facility: Nottingham University Hospitals City Campus

location_facility: Stanford University School of Medicine; Stanford Hospital Pharmacy

location_facility: Saint John Regional Hospital; Department of Oncology

location_facility: Lviv State Oncological Regional Treatment and Diagnostic Center

location_facility: Hospital do Espirito Santo; Servico de Oncologia Medica

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

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


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).

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.

repository_institution: University Library Bern - BORIS - Bern Open Repository and Information System

repository_institution: University of California - eScholarship University of California

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.

repositories_concat: PubMed Central;escholarship.org

publisher_dissemination: SAGE Publications

ReferenceCitation: Leppert D, Kropshofer H, Haring 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.

repository_institution: University of Zurich - Zurich Open Repository and Archive

repository_institution: University of Basel - edoc

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, Wallstrom 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_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

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


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.

repository_institution: PubMed Central - Europe PMC

lead_sponsor: Novo Nordisk A/S

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


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.

sponsor_collaborators:
Hoffmann-La Roche
Genentech, Inc.

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


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).

ReferenceCitation: Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi 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

lead_sponsor: Novartis Pharmaceuticals

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

location_facility: Compassionate Cancer Care Medical Group CCCMG

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

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

location_facility: Texas Oncology PA Dallas Presbyterian Hospital SC

location_facility: The West Clinic Dept. of the West Clinic

location_facility: LSU Health Sciences Center Feist-Weiller Cancer Center

location_facility: Oregon Health and Science University SC-5

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

location_facility: Moanalua Medical Center. Attn: Oncology Dept

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

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

location_facility: Northwest Cancer Specialists Compass Oncology -BKM

location_facility: Crescent City Research Consortium, LLC SC

location_facility: Morristown Memorial Hospital Morristown Mem

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

location_facility: University of Maryland Medical Center Univ Maryland

location_facility: University of Texas Southwestern Medical Center

location_facility: CINJ at Cooper University Hospital Dept of Onc

location_facility: University of California at Los Angeles UCLA SC

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

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


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

collaborators:
Pfizer
SFJ Pharmaceuticals, Inc.

sponsor_collaborators:
SFJ Pharma Ltd. II
Pfizer
SFJ Pharmaceuticals, Inc.

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


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.

repositories_institution: University of Zurich - Zurich Open Repository and Archive

ReferenceCitation: Robert C, Grob JJ, Stroyakovskiy D, Karaszewska B, Hauschild A, Levchenko E, Chiarion Sileni V, Schachter J, Garbe C, Bondarenko I, Gogas H, Mandala M, Haanen JBAG, Lebbe 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.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_concat: LIRIAS (KU Leuven)

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


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.

publisher_dissemination: SanovaWorks

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.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access

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.

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;:

repository_institution: Universitat Autònoma de Barcelona - Dipòsit Digital de Documents de la UAB

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, Stahle M, Edson-Heredia E, Zhu B, Amato D, Nikai 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.

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

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.