title: ASPIRE: Adult SPasticity International REgistry on BOTOX® Treatment

acronym: ASPIRE

summary: This is a registry study in adults with spasticity to determine onabotulinumtoxinA use in clinical practice. Treatment will be administered in accordance with physician standard practice. All treatment decisions lie with the physician.

ReferenceCitation: Esquenazi A, Francisco GE, Feng W, Baricich A, Gallien P, Fanning K, Zuzek A, Bandari DS, Wittenberg GF. Real-World Adherence to OnabotulinumtoxinA Treatment for Spasticity: Insights From the ASPIRE Study. Arch Phys Med Rehabil. 2021 Nov;102(11):2172-2184.e6. doi: 10.1016/j.apmr.2021.06.008. Epub 2021 Jul 7.

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories_concat: Zenodo

ReferenceCitation: Esquenazi A, Bavikatte G, Bandari DS, Jost WH, Munin MC, Tang SFT, Largent J, Adams AM, Zuzek A, Francisco GE. Long-Term Observational Results from the ASPIRE Study: OnabotulinumtoxinA Treatment for Adult Lower Limb Spasticity. PM R. 2021 Oct;13(10):1079-1093. doi: 10.1002/pmrj.12517. Epub 2021 Jan 11.

ReferenceCitation: Francisco GE, Jost WH, Bavikatte G, Bandari DS, Tang SFT, Munin MC, Largent J, Adams AM, Zuzek A, Esquenazi A. Individualized OnabotulinumtoxinA Treatment for Upper Limb Spasticity Resulted in High Clinician- and Patient-Reported Satisfaction: Long-Term Observational Results from the ASPIRE Study. PM R. 2020 Nov;12(11):1120-1133. doi: 10.1002/pmrj.12328. Epub 2020 Feb 27.

lead_sponsor: Allergan

location_country:
Germany
Italy
United Kingdom
United States
Spain
Taiwan
France

location_facility: Hospital Universitario Mutua de Terrassa

location_facility: Loma Linda University School Of Medicine

location_facility: Michigan Institute for Neurological Disorders

location_facility: University of Pittsburgh Medical Center Health System

location_facility: Emerald Coast Center for Neurological Disorders

location_facility: Hospital Universitario Marques de Valdecilla

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Hospital Clinic i Provincial de Barcelona

location_facility: The Curators of the University of Missouri on behalf of University of Missouri Health Care

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carità

location_facility: Dayton Center for Neurological Disorders

location_facility: Hospital de Conxo (Santiago de Compostela) GALICIA

location_facility: Nottingham University Hospitals City Campus

location_facility: Albert Einstein Healthcare Network, Moss Rehabilitation Hospital

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari

location_facility: The National Hospital for Neurology & Neurosurgery


type: EudraCT Number

title: A Phase 1/2, Multicenter, Open-Label, Dose-Escalation and Expansion, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects With Advanced Hematologic Malignancies With an IDH2 Mutation

summary:
The primary objectives of Phase 1 Dose Escalation/Part 1 Expansion are:

To assess the safety and tolerability of treatment with enasidenib administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle in participants with advanced hematologic malignancies.
To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and/or the recommended Phase 2 dose (RP2D) of enasidenib in participants with advanced hematologic malignancies.

The primary objective of Phase 2 is:

• To assess the efficacy of enasidenib as treatment for participants with relapsed or refractory (R/R) acute myelogenous leukemia (AML) with an IDH2 mutation.

study_start_date_type: Actual

status: Active, not recruiting

study_completion_date_type: Anticipated

study_type: Interventional

primary_purpose: Treatment

enrollment_type: Actual

ReferenceType: background

ReferenceCitation: Stein EM, DiNardo CD, Pollyea DA, Fathi AT, Roboz GJ, Altman JK, Stone RM, DeAngelo DJ, Levine RL, Flinn IW, Kantarjian HM, Collins R, Patel MR, Frankel AE, Stein A, Sekeres MA, Swords RT, Medeiros BC, Willekens C, Vyas P, Tosolini A, Xu Q, Knight RD, Yen KE, Agresta S, de Botton S, Tallman MS. Enasidenib in mutant IDH2 relapsed or refractory acute myeloid leukemia. Blood. 2017 Aug 10;130(6):722-731. doi: 10.1182/blood-2017-04-779405. Epub 2017 Jun 6.

ReferenceCitation: Fathi AT, DiNardo CD, Kline I, Kenvin L, Gupta I, Attar EC, Stein EM, de Botton S; AG221-C-001 Study Investigators. Differentiation Syndrome Associated With Enasidenib, a Selective Inhibitor of Mutant Isocitrate Dehydrogenase 2: Analysis of a Phase 1/2 Study. JAMA Oncol. 2018 Aug 1;4(8):1106-1110. doi: 10.1001/jamaoncol.2017.4695.

ReferenceCitation: Stein EM, DiNardo CD, Fathi AT, Pollyea DA, Stone RM, Altman JK, Roboz GJ, Patel MR, Collins R, Flinn IW, Sekeres MA, Stein AS, Kantarjian HM, Levine RL, Vyas P, MacBeth KJ, Tosolini A, VanOostendorp J, Xu Q, Gupta I, Lila T, Risueno A, Yen KE, Wu B, Attar EC, Tallman MS, de Botton S. Molecular remission and response patterns in patients with mutant-IDH2 acute myeloid leukemia treated with enasidenib. Blood. 2019 Feb 14;133(7):676-687. doi: 10.1182/blood-2018-08-869008. Epub 2018 Dec 3.

ReferenceCitation: Pollyea DA, Tallman MS, de Botton S, Kantarjian HM, Collins R, Stein AS, Frattini MG, Xu Q, Tosolini A, See WL, MacBeth KJ, Agresta SV, Attar EC, DiNardo CD, Stein EM. Enasidenib, an inhibitor of mutant IDH2 proteins, induces durable remissions in older patients with newly diagnosed acute myeloid leukemia. Leukemia. 2019 Nov;33(11):2575-2584. doi: 10.1038/s41375-019-0472-2. Epub 2019 Apr 9.

ReferenceCitation: Quek L, David MD, Kennedy A, Metzner M, Amatangelo M, Shih A, Stoilova B, Quivoron C, Heiblig M, Willekens C, Saada V, Alsafadi S, Vijayabaskar MS, Peniket A, Bernard OA, Agresta S, Yen K, MacBeth K, Stein E, Vassiliou GS, Levine R, De Botton S, Thakurta A, Penard-Lacronique V, Vyas P. Clonal heterogeneity of acute myeloid leukemia treated with the IDH2 inhibitor enasidenib. Nat Med. 2018 Aug;24(8):1167-1177. doi: 10.1038/s41591-018-0115-6. Epub 2018 Jul 16.

ReferenceCitation: Amatangelo MD, Quek L, Shih A, Stein EM, Roshal M, David MD, Marteyn B, Farnoud NR, de Botton S, Bernard OA, Wu B, Yen KE, Tallman MS, Papaemmanuil E, Penard-Lacronique V, Thakurta A, Vyas P, Levine RL. Enasidenib induces acute myeloid leukemia cell differentiation to promote clinical response. Blood. 2017 Aug 10;130(6):732-741. doi: 10.1182/blood-2017-04-779447. Epub 2017 Jun 6.

ReferenceCitation: Shih AH, Meydan C, Shank K, Garrett-Bakelman FE, Ward PS, Intlekofer AM, Nazir A, Stein EM, Knapp K, Glass J, Travins J, Straley K, Gliser C, Mason CE, Yen K, Thompson CB, Melnick A, Levine RL. Combination Targeted Therapy to Disrupt Aberrant Oncogenic Signaling and Reverse Epigenetic Dysfunction in IDH2- and TET2-Mutant Acute Myeloid Leukemia. Cancer Discov. 2017 May;7(5):494-505. doi: 10.1158/2159-8290.CD-16-1049. Epub 2017 Feb 13.

ReferenceType: result

ReferenceCitation: Stein EM, Fathi AT, DiNardo CD, Pollyea DA, Roboz GJ, Collins R, Sekeres MA, Stone RM, Attar EC, Frattini MG, Tosolini A, Xu Q, See WL, MacBeth KJ, de Botton S, Tallman MS, Kantarjian HM. Enasidenib in patients with mutant IDH2 myelodysplastic syndromes: a phase 1 subgroup analysis of the multicentre, AG221-C-001 trial. Lancet Haematol. 2020 Apr;7(4):e309-e319. doi: 10.1016/S2352-3026(19)30284-4. Epub 2020 Mar 5.

oa_host_type: closed

repositories_concat: closed

publisher_dissemination: Elsevier

ReferenceCitation: Intlekofer AM, Shih AH, Wang B, Nazir A, Rustenburg AS, Albanese SK, Patel M, Famulare C, Correa FM, Takemoto N, Durani V, Liu H, Taylor J, Farnoud N, Papaemmanuil E, Cross JR, Tallman MS, Arcila ME, Roshal M, Petsko GA, Wu B, Choe S, Konteatis ZD, Biller SA, Chodera JD, Thompson CB, Levine RL, Stein EM. Acquired resistance to IDH inhibition through trans or cis dimer-interface mutations. Nature. 2018 Jul;559(7712):125-129. doi: 10.1038/s41586-018-0251-7. Epub 2018 Jun 27.

oa_host_type: repository

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

host_type: repository

license: unspecified-oa

license_normalized: unspecified-oa

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

version: acceptedVersion

evidence: oa repository (via pmcid lookup)

license_normalized: no license

repositories_concat: PubMed Central

unpaywall_oa_status: green

publisher_dissemination: Springer-Nature

ReferenceCitation: Stein EM. Enasidenib, a targeted inhibitor of mutant IDH2 proteins for treatment of relapsed or refractory acute myeloid leukemia. Future Oncol. 2018 Jan;14(1):23-40. doi: 10.2217/fon-2017-0392. Epub 2017 Sep 18.

publisher_dissemination: Future Science Ltd

ReferenceType: derived

ReferenceCitation: de Botton S, Brandwein JM, Wei AH, Pigneux A, Quesnel B, Thomas X, Legrand O, Recher C, Chantepie S, Hunault-Berger M, Boissel N, Nehme SA, Frattini MG, Tosolini A, Marion-Gallois R, Wang JJ, Cameron C, Siddiqui M, Hutton B, Milkovich G, Stein EM. Improved survival with enasidenib versus standard of care in relapsed/refractory acute myeloid leukemia associated with IDH2 mutations using historical data and propensity score matching analysis. Cancer Med. 2021 Sep;10(18):6336-6343. doi: 10.1002/cam4.4182. Epub 2021 Aug 24.

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by

license_normalized: cc-by

version: publishedVersion

unpaywall_oa_status: gold

publisher_dissemination: Wiley

lead_sponsor: Celgene

sponsor_collaborators:
Celgene
Agios Pharmaceuticals, Inc.

location_country:
United States
France

location_facility: Ut Southwestern Medical Center At Dallas

location_facility: Memorial Sloan-Kettering Cancer Center - NYC

location_facility: Oregon Health and Science University OHSU

location_facility: Cornell University Weill Medical College

location_facility: Dana-Farber/Mass General Brigham Cancer Care, Inc

location_facility: University of Miami Sylvester Cancer Center

location_facility: Sarah Cannon Research Institute Drug Development Unit

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


title: REDUCE LAP-HF TRIAL: A Study to Evaluate the DC Devices, Inc. IASD™ System II to REDUCE Elevated Left Atrial Pressure in Patients With Heart Failure

acronym: REDUCE LAP-HF

summary: The objective of this clinical study is to evaluate the safety and performance of the IASD System II in the treatment of heart failure patients with elevated left atrial pressure, who remain symptomatic despite appropriate medical management.

status: Completed

study_completion_date_type: Actual

ReferenceCitation: Hasenfuss G, Gustafsson F, Kaye D, Shah SJ, Burkhoff D, Reymond MC, Komtebedde J, Hunlich M; Reduce LAP-HF Trial Investigators. Rationale and Design of the Reduce Elevated Left Atrial Pressure in Patients With Heart Failure (Reduce LAP-HF) Trial. J Card Fail. 2015 Jul;21(7):594-600. doi: 10.1016/j.cardfail.2015.05.008. Epub 2015 Jun 6.

ReferenceCitation: Hasenfuss G, Hayward C, Burkhoff D, Silvestry FE, McKenzie S, Gustafsson F, Malek F, Van der Heyden J, Lang I, Petrie MC, Cleland JG, Leon M, Kaye DM; REDUCE LAP-HF study investigators. A transcatheter intracardiac shunt device for heart failure with preserved ejection fraction (REDUCE LAP-HF): a multicentre, open-label, single-arm, phase 1 trial. Lancet. 2016 Mar 26;387(10025):1298-304. doi: 10.1016/S0140-6736(16)00704-2.

repository_institution: The University of Glasgow - Enlighten: Publications

license: cc-by-nc-nd

license_normalized: cc-by-nc-nd

repository_institution: Imperial College London - Spiral

version: submittedVersion

ReferenceCitation: Kaye DM, Hasenfuss G, Neuzil P, Post MC, Doughty R, Trochu JN, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Walton A, Muller D, Walters D, Hausleiter J, Raake P, Petrie MC, Bergmann M, Jondeau G, Feldman T, Veldhuisen DJ, Ponikowski P, Silvestry FE, Burkhoff D, Hayward C. One-Year Outcomes After Transcatheter Insertion of an Interatrial Shunt Device for the Management of Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2016 Dec;9(12):e003662. doi: 10.1161/CIRCHEARTFAILURE.116.003662.

oa_colors: green hybrid

evidence: open (via page says license)

license: cc-by-nc

license_normalized: cc-by-nc

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

unpaywall_oa_status: hybrid

publisher_dissemination: Wolters Kluwer Health

ReferenceCitation: Wolsk E, Kaye D, Borlaug BA, Burkhoff D, Kitzman DW, Komtebedde J, Lam CSP, Ponikowski P, Shah SJ, Gustafsson F. Resting and exercise haemodynamics in relation to six-minute walk test in patients with heart failure and preserved ejection fraction. Eur J Heart Fail. 2018 Apr;20(4):715-722. doi: 10.1002/ejhf.976. Epub 2017 Sep 26.

oa_colors: green other

evidence: open (via free article)

unpaywall_oa_status: bronze

ReferenceCitation: Kaye DM, Petrie MC, McKenzie S, Hasenfubeta G, Malek F, Post M, Doughty RN, Trochu JN, Gustafsson F, Lang I, Kolodziej A, Westenfeld R, Penicka M, Rosenberg M, Hausleiter J, Raake P, Jondeau G, Bergmann MW, Spelman T, Aytug H, Ponikowski P, Hayward C; REDUCE LAP-HF study investigators. Impact of an interatrial shunt device on survival and heart failure hospitalization in patients with preserved ejection fraction. ESC Heart Fail. 2019 Feb;6(1):62-69. doi: 10.1002/ehf2.12350. Epub 2018 Oct 11.

repositories_concat: PubMed Central;University of Melbourne - Minerva Access;eprints.gla.ac.uk

ReferenceCitation: Wessler J, Kaye D, Gustafsson F, Petrie MC, Hasenfubeta G, Lam CSP, Borlaug BA, Komtebedde J, Feldman T, Shah SJ, Burkhoff D; REDUCE-LAP-HF Trial Investigators and Advisors. Impact of Baseline Hemodynamics on the Effects of a Transcatheter Interatrial Shunt Device in Heart Failure With Preserved Ejection Fraction. Circ Heart Fail. 2018 Aug;11(8):e004540. doi: 10.1161/CIRCHEARTFAILURE.117.004540.

ReferenceCitation: Hanff TC, Kaye DM, Hayward CS, Post MC, Malek F, Hasenfubeta G, Gustafsson F, Burkhoff D, Shah SJ, Litwin SE, Kahwash R, Hummel SL, Borlaug BA, Solomon SD, Lam CSP, Komtebedde J, Silvestry FE; REDUCE LAP-HF study investigators, and research staff. Assessment of Predictors of Left Atrial Volume Response to a Transcatheter InterAtrial Shunt Device (from the REDUCE LAP-HF Trial). Am J Cardiol. 2019 Dec 15;124(12):1912-1917. doi: 10.1016/j.amjcard.2019.09.019. Epub 2019 Sep 26.

ReferenceCitation: Obokata M, Reddy YNV, Shah SJ, Kaye DM, Gustafsson F, Hasenfubeta G, Hoendermis E, Litwin SE, Komtebedde J, Lam C, Burkhoff D, Borlaug BA. Effects of Interatrial Shunt on Pulmonary Vascular Function in Heart Failure With Preserved Ejection Fraction. J Am Coll Cardiol. 2019 Nov 26;74(21):2539-2550. doi: 10.1016/j.jacc.2019.08.1062.

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

location_country:
Germany
Poland
New Zealand
United Kingdom
Denmark
Australia
Netherlands
Austria
Belgium
Czechia
France

location_facility: Allgemeines Krankenhaus Univesitäts Kliniken


type: Other Identifier

title: A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib (Velcade) in Patients With Multiple Myeloma in First or Second Relapse.

acronym: OPTIMRETREAT

summary: The objective of this study is to describe the effect of optimized retreatment with bortezomib in combination with dexamethasone followed by prolonged therapy with bortezomib, versus standard retreatment with bortezomib in combination with dexamethasone on progression free survival (PFS).

design_allocation: Randomized

ReferenceCitation: Terpos E, Gobbi M, Potamianou A, Lahaye M, Couturier C, Cavo M. Retreatment and prolonged therapy with subcutaneous bortezomib in patients with relapsed multiple myeloma: A randomized, controlled, phase III study. Eur J Haematol. 2018 Jan;100(1):10-19. doi: 10.1111/ejh.12937. Epub 2017 Oct 30.

lead_sponsor: Janssen-Cilag International NV

location_country: Finland Germany France Poland Portugal Norway Sweden Netherlands Belgium Turkey Israel

status_simplified: Completed


lead_sponsor: Hoffmann-La Roche

summary: This multicenter, open-label, randomized study will evaluate the efficacy and safety of Atezolizumab compared with docetaxel in participants with advanced or metastatic non-small cell lung cancer after platinum failure. Participants will be randomized to receive either Atezolizumab 1200 milligram (mg) intravenously every 3 weeks or docetaxel 75 milligram per meter square (mg/m^2) intravenously every 3 weeks. Treatment with Atezolizumab may be continued as long as participants are experiencing clinical benefit as assessed by the investigator, i.e., in the absence of unacceptable toxicity or symptomatic deterioration attributed to disease progression.

ReferenceCitation: Shemesh CS, Chan P, Legrand FA, Shames DS, Das Thakur M, Shi J, Bailey L, Vadhavkar S, He X, Zhang W, Bruno R. Pan-cancer population pharmacokinetics and exposure-safety and -efficacy analyses of atezolizumab in patients with high tumor mutational burden. Pharmacol Res Perspect. 2020 Dec;8(6):e00685. doi: 10.1002/prp2.685.

ReferenceCitation: Chalabi M, Cardona A, Nagarkar DR, Dhawahir Scala A, Gandara DR, Rittmeyer A, Albert ML, Powles T, Kok M, Herrera FG; imCORE working group of early career investigators. Efficacy of chemotherapy and atezolizumab in patients with non-small-cell lung cancer receiving antibiotics and proton pump inhibitors: pooled post hoc analyses of the OAK and POPLAR trials. Ann Oncol. 2020 Apr;31(4):525-531. doi: 10.1016/j.annonc.2020.01.006. Epub 2020 Jan 16.

oa_host_type: publisher

evidence: open (via crossref license)

ReferenceCitation: Fehlings M, Jhunjhunwala S, Kowanetz M, O'Gorman WE, Hegde PS, Sumatoh H, Lee BH, Nardin A, Becht E, Flynn S, Ballinger M, Newell EW, Yadav M. Late-differentiated effector neoantigen-specific CD8+ T cells are enriched in peripheral blood of non-small cell lung carcinoma patients responding to atezolizumab treatment. J Immunother Cancer. 2019 Sep 12;7(1):249. doi: 10.1186/s40425-019-0695-9.

publisher_dissemination: British Medical Journal

ReferenceCitation: Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A; POPLAR Study Group. Atezolizumab versus docetaxel for patients with previously treated non-small-cell lung cancer (POPLAR): a multicentre, open-label, phase 2 randomised controlled trial. Lancet. 2016 Apr 30;387(10030):1837-46. doi: 10.1016/S0140-6736(16)00587-0. Epub 2016 Mar 10.

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

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Rocky Mountain Cancer Centers - Colorado Springs (Circle)

location_facility: Irccs Ospedale San Raffaele;Oncologia Medica

location_facility: Centrum Onkologii - Instytut im. Marii Skłodowskiej-Curie Klinika Nowotworów Piersi i Chirurgii

location_facility: Chulalongkorn Hospital; Medical Oncology

location_facility: Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology

location_facility: Hospital Universitario Miguel Servet; Servicio Oncologia

location_facility: Cite de La Sante de Laval; Hemato-Oncologie

location_facility: National Cancer Center; Medical Oncology

location_facility: Northwest Cancer Specialists - Vancouver

location_facility: Woj.Wielospecjalistyczne Centrum Onkologii i Traumatologii; Oddz.Hematologii Pododz.Chemioterapii

location_facility: Krankenhaus Martha-Maria Halle-Doelau gGmbH; Klinik fuer Innere Medizin II

location_facility: Centre D'Oncologie de Gentilly; Oncology

location_facility: Comprehensive Cancer Centers of Nevada - Eastern Avenue

location_facility: Christie Hospital Nhs Trust; Medical Oncology

location_facility: Charing Cross Hospital; Medical Oncology.

location_facility: Akdeniz University Medical Faculty; Medical Oncology Department

location_facility: Hopital Gabriel Montpied; Service de Pneumologie

location_facility: Centre Hospitalier de Saint Brieuc - Hôpital Yves Le Foll; Pneumologie

location_facility: Providence St. Mary Regional Cancer Center

location_facility: Samsung Medical Centre; Division of Hematology/Oncology

location_facility: Willamette Valley Cancer Ctr - 520 Country Club

location_facility: Universitätsklinikum Regensburg; Klinik und Poliklinik für Innere Medizin II, Pneumologie

location_facility: Hospital Ramon y Cajal; Servicio de Oncologia

location_facility: Hospital Universitario 12 de Octubre; Servicio de Oncologia

location_facility: Rajavithi Hospital; Division of Medical Oncology

location_facility: Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology

location_facility: McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology

location_facility: Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

location_facility: Mazowieckie Centrum Leczenia Chorob Pluc I Gruzlicy; Oddzial Iii

location_facility: Citta Ospedaliera; Divisione Oncologia Medica

title: A Phase II, Open-label, Multicenter, Randomized Study to Investigate the Efficacy and Safety of MPDL3280A (Anti-PD-L1 Antibody) Compared With Docetaxel in Patients With Non-Small Cell Lung Cancer After Platinum Failure

source: euctr

location_country:
Germany
Italy
Poland
United Kingdom
Sweden
Belgium
United States
Korea, Republic of
Spain
Thailand
Turkey
Canada
France


lead_sponsor: Pfizer

summary: The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.

ReferenceCitation: Takahashi N, Cortes JE, Sakaida E, Ishizawa K, Ono T, Doki N, Matsumura I, Garcia-Gutierrez V, Rosti G, Ono C, Ohkura M, Tanetsugu Y, Viqueira A, Brummendorf TH. Safety profile of bosutinib in Japanese versus non-Japanese patients with chronic myeloid leukemia: a pooled analysis. Int J Hematol. 2022 Jun;115(6):838-851. doi: 10.1007/s12185-022-03314-y. Epub 2022 Mar 2.

location_facility: Nottingham University Hospitals NHS Trust

location_facility: Faculdade de Medicina do ABC - Centro de Estudos e Pesquisa em Hematologia e Oncologia (CEPHO)

location_facility: Ruijin Hospital- Shanghai Jiaotong University School of Medicine

location_facility: Unidad de Investigacion de Hematologia - Hospital Nacional Edgardo Rebagliati Martins

location_facility: Hospital Clinico Universitario De Valencia (CHUV)

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz, Belgyogyaszati Osztaly

location_facility: State Budgetary Institution of Healthcare of Sverdlovsk Region

location_facility: Instituto Medico Especializado Alexander Fleming

location_facility: Northside Hospital, Inc. - Central Research Department

location_facility: Sir Mortimer B. Davis-Jewish General Hospital

location_facility: Universidade Estadual de Campinas / Centro de Hematologia e Hemoterapia

location_facility: Wits Clinical Research-Chris Hani Baragwanath Hospital

location_facility: State Budgetary Educational Institution of Higher Professional Education

location_facility: The University of Texas, MD Anderson Cancer Center

location_facility: Hamamatsu University School of Medicine University Hospital

location_facility: Hudson Valley Hematology and Oncology Associates

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Kyiv City Clinical Hospital #9, SI "Institute of Hematology and Transfusiology of NAMS of Ukraine"

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet

location_facility: Division of Hematology, Department of Medicine, Faculty of Medicine, Siriraj Hospital,

location_facility: Chinese People's Liberation Army General Hospital

location_facility: Clinic "Institute of Pediatric Oncology, Hematology and Transplantation n.a. R.M. Gorbachova"

location_facility: Strasbourg Oncologie Liberale -Centre de Radiotherapie, Clinique Ste Anne

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

location_facility: Pamela Youde Nethersole Eastern Hospital

location_facility: Department of Medicine & Therapeutics, Prince of Wales Hospital

location_facility: Alberta Health Services - Department of Medical Oncology - Cross Cancer Institute

location_facility: State Institution "Institute of Blood Pathology and Transfusion Medicine of

location_facility: Blood Disease Hospital, Chinese Academy of Medical Science & Peking Union Medical College

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Lublinie

location_facility: Federal State Budgetary Institution "Federal Almazov Medical Research Centre"

location_facility: State Institution "National Research Center for Radiation Medicine of the National Academy of

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: State Budgetary Institution of Rostov Region - Rostov Regional Clinical Hospital

location_facility: Federal State-Funded Institution National Research Center of Hematology of the Ministry of

location_facility: State Budgetary Institution of Healthcare - Leningrad Regional Clinical Hospital

location_facility: MI "Dnipropetrovsk City Multi-field Clinical Hospital #4" of DRC Hematology Center

location_facility: Northside Hospital Inc., - GCS/Northside

location_facility: Tokyo Metropolitan Cancer and Infectious diseases Center Komagome Hospital

location_facility: University Medical Center Groningen, Department of Hematology

location_facility: The First affiliated Hospital of College of Medicine, Zhejiang University

location_facility: Hospital Universitario Madrid Sanchinarro, Centro Integral Oncologico Clara Campal

location_facility: Gaziantep Universitesi Tip Fakultesi Sahinbey Uygulama ve Arastirma Hastanesi

location_facility: Winship Cancer Institute, Emory University

location_facility: Municipal Institution "Cherkasy Regional Oncology Dispensary"

location_facility: Helsingin Yliopistollinen Keskussairaala, Hematologian poliklinikka

location_facility: State Budgetary Institution of Healthcare Samara Regional Clinical Hospital n.a. V.D. Seredavin

location_facility: Indiana Blood and Marrow Transplantation

location_facility: Siouxland Hematology-Oncology Associates, LLP

title: AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

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:
Finland
Poland
Argentina
Australia
Brazil
Japan
Thailand
Turkey
Chile
Canada
France
Colombia
Hungary
Hong Kong
United States
Latvia
Ukraine
India
Belgium
China
Peru
Italy
United Kingdom
Singapore
Netherlands
Korea, Republic of
Spain
South Africa
Russian Federation

ipd_sharing: No


title: A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

summary: To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis (MS)

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Deiva K, Huppke P, Banwell B, Chitnis T, Gartner J, Krupp L, Waubant E, Stites T, Pearce GL, Merschhemke M. Consistent control of disease activity with fingolimod versus IFN beta-1a in paediatric-onset multiple sclerosis: further insights from PARADIGMS. J Neurol Neurosurg Psychiatry. 2020 Jan;91(1):58-66. doi: 10.1136/jnnp-2019-321124. Epub 2019 Aug 29.

ReferenceCitation: Chitnis T, Arnold DL, Banwell B, Bruck W, Ghezzi A, Giovannoni G, Greenberg B, Krupp L, Rostasy K, Tardieu M, Waubant E, Wolinsky JS, Bar-Or A, Stites T, Chen Y, Putzki N, Merschhemke M, Gartner J; PARADIGMS Study Group. Trial of Fingolimod versus Interferon Beta-1a in Pediatric Multiple Sclerosis. N Engl J Med. 2018 Sep 13;379(11):1017-1027. doi: 10.1056/NEJMoa1800149.

publisher_dissemination: Massachusetts Medical Society

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:
Germany
Poland
Australia
Brazil
Turkey
Croatia
Canada
Serbia
France
Belarus
Lithuania
Slovakia
United States
Latvia
Ukraine
Romania
Estonia
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Spain
Bulgaria
Russian Federation
Sweden


title: A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma

acronym: DYNAMO

summary: This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma [FL], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

ReferenceCitation: Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11. Erratum In: J Clin Oncol. 2019 Jun 1;37(16):1448.

publisher_dissemination: American Society of Clinical Oncology (ASCO)

lead_sponsor: SecuraBio

location_country:
Belarus
Italy
Hungary
United Kingdom
Belgium
United States
Spain
Georgia
Czechia
Bulgaria
Canada
France


acronym: VERIFY

lead_sponsor: Genzyme, a Sanofi Company

summary:
Primary Objective:

To determine the efficacy (as assessed by progression-free survival [PFS]) of vandetanib when compared to placebo in participants with differentiated thyroid cancer that is either locally advanced or metastatic who are refractory or unsuitable for radioiodine therapy.

Secondary Objectives:

To determine the efficacy of vandetanib when compared to placebo in this participant population as assessed by efficacy variables including duration of response (DOR), objective response rate (ORR), change in tumour size (TS) and overall survival (OS).
To evaluate the pharmacokinetics (PK) of vandetanib in this participant population and potentially investigate any influence of participant demography and pathophysiology on vandetanib PK.
To demonstrate an improvement in time to worsening of pain (TWP) in participants treated with vandetanib when compared to placebo in this participant population.
To evaluate the safety and tolerability of vandetanib treatment in this participant population.

location_facility:
Research Site
Washington University

title: A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Phase III Study to Assess the Efficacy and Safety of Vandetanib (CAPRELSA™; SAR390530 (Formerly AstraZeneca ZD6474)) 300 mg in Patients With Differentiated Thyroid Cancer That Is Either Locally Advanced or Metastatic Who Are Refractory or Unsuitable for Radioiodine (RAI) Therapy.

location_country:
Italy
Poland
Denmark
Japan
Brazil
Sweden
United States
China
Spain
Czechia
Russian Federation
France


title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Safety and Efficacy of Different Oral Doses of BAY94-8862 in Subjects With Type 2 Diabetes Mellitus and the Clinical Diagnosis of Diabetic Nephropathy

acronym: ARTS-DN

summary: To assess a new drug, BAY94-8862 given orally at different doses, to evaluate whether it was safe and can help the well being of patients with type 2 diabetes and diabetic nephropathy. These treatment doses were compared to placebo.

ReferenceCitation: Bakris GL, Agarwal R, Chan JC, Cooper ME, Gansevoort RT, Haller H, Remuzzi G, Rossing P, Schmieder RE, Nowack C, Kolkhof P, Joseph A, Pieper A, Kimmeskamp-Kirschbaum N, Ruilope LM; Mineralocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy (ARTS-DN) Study Group. Effect of Finerenone on Albuminuria in Patients With Diabetic Nephropathy: A Randomized Clinical Trial. JAMA. 2015 Sep 1;314(9):884-94. doi: 10.1001/jama.2015.10081.

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

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

publisher_dissemination: American Medical Association

ReferenceCitation: Snelder N, Heinig R, Drenth HJ, Joseph A, Kolkhof P, Lippert J, Garmann D, Ploeger B, Eissing T. Population Pharmacokinetic and Exposure-Response Analysis of Finerenone: Insights Based on Phase IIb Data and Simulations to Support Dose Selection for Pivotal Trials in Type 2 Diabetes with Chronic Kidney Disease. Clin Pharmacokinet. 2020 Mar;59(3):359-370. doi: 10.1007/s40262-019-00820-x.

ReferenceCitation: Chung EY, Ruospo M, Natale P, Bolignano D, Navaneethan SD, Palmer SC, Strippoli GF. Aldosterone antagonists in addition to renin angiotensin system antagonists for preventing the progression of chronic kidney disease. Cochrane Database Syst Rev. 2020 Oct 27;10(10):CD007004. doi: 10.1002/14651858.CD007004.pub4.

ReferenceCitation: Erraez S, Lopez-Mesa M, Gomez-Fernandez P. Mineralcorticoid receptor blockers in chronic kidney disease. Nefrologia (Engl Ed). 2021 May-Jun;41(3):258-275. doi: 10.1016/j.nefro.2020.10.001. Epub 2020 Dec 24. English, Spanish.

lead_sponsor: Bayer

location_country:
Finland
Germany
Poland
Australia
Czechia
Canada
France
Portugal
Hungary
Hong Kong
Denmark
United States
Italy
Norway
Sweden
Netherlands
Austria
Korea, Republic of
Spain
South Africa
Taiwan
Bulgaria
Israel


summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.

ReferenceCitation: Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

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

repository_institution: University of Illinois at Chicago - INDIGO

repository_institution: Cold Spring Harbor Laboratory - medRxiv

repository_normalized: medRxiv

repositories:
PubMed Central
figshare.com
medRxiv

repositories_concat: PubMed Central;figshare.com;medRxiv

location_facility: Ospedale Morgagni-Pierantoni; U.O. Pneumologia

location_facility: Highland Hospital-University of Rochester Medical Center

location_facility: Instituto Nacional De Enfermedades Respiratorias;Unidad de Investigación

location_facility: Weill Medical College of Cornell University

location_facility: Ospedale San Giuseppe; U.O. di Pneumologia

location_facility: Hospital Universitari de Bellvitge ; Servicio de Neumologia

location_facility: Southmead Hospital; Respiratory Department

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Klinika Pulmonologii, Alergologii i Onkologii Pulmonologicznej Uniwersytet Medyczny w Poznaniu

location_facility: Hospital Clínico San Carlos - Servicio de Neumologia

location_facility: A.O. Universitaria San Luigi Gonzaga di Orbassano; Ambulatorio per le Malattie Rare del Polmone

location_facility: Cardiopulmonary Associates LLC Cardiopulmonary Research

location_facility: University of Pittsburgh Med Cen; Dorothy P And Richard P Simmons Cen For Interstitial Lung Disease

location_facility: CPC Comprehensive Pneumology Center / Forschungsambulanz, Helmholtz Zentrum

location_facility: Hospital General Universitario De Valencia; Servicio de Neumologia

location_facility: Oklahoma University Health Sciences Center

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec (Hôpital Laval)

location_facility: Case Western Research University; University Hospitals Case Medical Center

location_facility: Inova Transplant Center Fairfax Hospital

location_facility: Universitätsklinikum Standort Gießen Medizinische Klinik II u. Poliklinik Innere Med./Pneumologie

location_facility: Royal Prince Alfred Hospital; Department of Respiratory Medicine

location_facility: University of Minnesota Hospital & Clinic

location_facility: A.O. Univ. Senese Policlinico S. Maria alle Scotte; UOC Malattie Resepiratorie e Trapianto Polmonare

location_facility: Southampton General Hospital; Respiratory Department

location_facility: Temple Lung Center, Temple Universtiy-Of the Commomwealth System of Higher Education

location_facility: Ms Clinsearch Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej

location_facility: Royal Brompton Hospital; Respiratory Department

location_facility: Uniwersytecki Szpital Kliniczny Nr 1 im.N.Barlickiego Oddzial Kliniczny Pneumonologii i Alergologii

location_facility: Policlinico Tor Vergata; UO Mal. Respiratorie; Centro Malattie rare polmone

location_facility: University Wisconsin Hospitals and Clinics

location_facility: Hopital Bichat Claude Bernard ; Service de Pneumologie

location_facility: A.O.U. Policlinico Vittorio Emanuele; Centro per la cura delle Malattie Rare del Polmone

location_facility: University of Chicago; Pulmonary and Critical Care

location_facility: ST VINCENT'S HOSPITAL; Thoracic Medicine

location_facility: Southern Arizona Veterans Administration Healthcare Systems

location_facility: Mt Sinai School Medical Pulmo And Critical Care Med

location_facility: Johns Hopkins Bayview Medical Center - Johns Hopkins Asthma & Allergy Center

location_facility: Klinika Chorob Pluc i Gruzlicy w Zabrzu; Slaski Uniwersytet Medyczny

location_facility: Hopital de Pontchaillou; Service de Pneumologie

location_facility: University of Utah Health Sciences Center, Lung Health Research Center

location_facility: Clinica Internacional, Sede San Borja; Unidad de Investigacion de Clínica Internacional

location_facility: North Manchester Hospital; Respiratory Department

location_facility: Hospital General Del Estado De Sonora "Dr. Ernesto Ramos Bours"; Servicio De Neumologia

location_facility: University of British Columbia - Vancouver Coastal Health Authority

location_facility: St James University Hospital; Respiratory Department

location_facility: Penn State University College Medical Allergy And Care Med

location_facility: Papworth Hospital NHS Foundation Trust; Respiratory Department

location_facility: Kanagawa Cardiovascular and Respiratory Center; Respiratory Medicine

location_facility: University Vermont College Medicine Fletcher Allen Health Care

location_facility: Hospital Universitario Virgen del Rocio; Servicio de Neumologia

location_facility: Hospital Universitario La Princesa; Servicio de Neumologia

location_facility: Maine Medical Center -Division of Pulmomary and Critical Care Medicine

location_facility: Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute

location_facility: Respiratory research department clinical science building

location_facility: Ruhrlandklinik Lungenzentrum der UNI Essen Abt.Pneumologie-Allergologie

location_facility: Rocky Mountain Center For Clinical Research

location_facility: Unidad de Investigacion Clinica En Medicina (Udicem) S.C.

location_facility: Universidad Autonoma De Nuevo Leon, Hospital Universitario Doctor Jose Eleuterio Gonzalez

location_facility: Via Christi Hospital Inc. DBA Via Christi Research; Research Dept.

location_facility: Piedmont Healthcare Pulmonary and Critical Care Research

title: A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis

location_country:
Germany
Italy
Poland
United Kingdom
Australia
Japan
Mexico
Belgium
United States
Spain
Peru
Canada
France


title: MGuard™ Prime Stent System Clinical Trial in Patients With Acute ST Elevation Myocardial Infarction

acronym: MASTER-II

summary: To evaluate the safety and efficacy of the MGuard™ Prime stent in the treatment of blocked arteries in coronary arteries in patients undergoing a stenting procedure due to having a heart attack. The MGuard Prime stent wil be compared to other FDA approved bare-metal (BMS) or drug-eluting (DES) coronary stents. The hypotheses are that (1) the MGuard Prime stent will achieve a higher rate of complete ST-segment resolution as seen on the post-procedure ECG as compared to the comparator stent, and will have a similar effect on the rate of all-cause death or recurrent target vessel myocardial infarction at 365 days post-procedure.

status: Terminated

lead_sponsor: InspireMD

location_country:
Finland
France
Germany
Poland
Israel
United Kingdom
Netherlands
Belgium
United States
Spain
Estonia
Czech Republic

location_facility: Charité Universitätsklinikum Berlin Campus Virchow

location_facility: Cardiology Associates of North Mississippi

location_facility: Hospital Clinic, University of Barcelona

location_facility: University Hospitals Case Medical Center

location_facility: Krakowskie Centrum Kardiologii Inwazyjnej

location_facility: MedStar Southern Maryland Hospital Center

location_facility: Klinika Kardiologii i Angiologii Interwencyjnej

location_facility: University Hospitals Southampton NHS Foundation Trust

location_facility: Katedra i Klinika Kardiologii Uniwersytetu Medycznego w Łodzi

location_facility: Charité Universitätsklinikum Berlin Campus Benjamin Franklin

location_facility: Hospital Universitario Madrid Montepríncipe

intervention_type: Device

status_simplified: Unknown


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Uncontrolled Asthma Who Are on Inhaled Corticosteroids and a Second Controller Medication

summary: This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab in participants with asthma whose disease remains uncontrolled despite daily treatment with inhaled corticosteroid (ICS) therapy and at least one second controller medication. Participants will be randomized in 1:1:1 ratio to receive double-blind treatment with either lebrikizumab ("high" or "low") or placebo, administered subcutaneously (SC) every 4 weeks for 52 weeks, in addition to their standard-of-care therapy. This will be followed by a 52-week double-blind active treatment extension. During double-blind active treatment extension period, all participants will receive SC injection of lebrikizumab from Week 53 to Week 104. The anticipated time on study treatment is 104 weeks. After study treatment, all participants will complete a 20-week safety follow-up.

ReferenceCitation: Chen M, Shepard K 2nd, Yang M, Raut P, Pazwash H, Holweg CTJ, Choo E. Overlap of allergic, eosinophilic and type 2 inflammatory subtypes in moderate-to-severe asthma. Clin Exp Allergy. 2021 Apr;51(4):546-555. doi: 10.1111/cea.13790. Epub 2021 Jan 7.

ReferenceCitation: N Bauer R, Yang X, L Staton T, Olsson J, Holweg CTJ, R Arron J, Matthews JG, Choy DF. Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma. BMJ Open Respir Res. 2019 Nov 11;6(1):e000406. doi: 10.1136/bmjresp-2019-000406. eCollection 2019.

ReferenceCitation: Hanania NA, Korenblat P, Chapman KR, Bateman ED, Kopecky P, Paggiaro P, Yokoyama A, Olsson J, Gray S, Holweg CT, Eisner M, Asare C, Fischer SK, Peng K, Putnam WS, Matthews JG. Efficacy and safety of lebrikizumab in patients with uncontrolled asthma (LAVOLTA I and LAVOLTA II): replicate, phase 3, randomised, double-blind, placebo-controlled trials. Lancet Respir Med. 2016 Oct;4(10):781-796. doi: 10.1016/S2213-2600(16)30265-X. Epub 2016 Sep 5.

location_country:
Germany
Poland
New Zealand
Argentina
Australia
Japan
Turkey
Chile
Czechia
Canada
Serbia
France
Colombia
Slovakia
Hungary
United States
Ukraine
Romania
Belgium
Italy
United Kingdom
Mexico
Korea, Republic of
Spain
South Africa
Russian Federation
Israel

location_facility: National Hospital Organization Tokyo National Hospital

location_facility: Allergy & Asthma Care of FL; Clinical Research

location_facility: Atatürk Göğüs Hastalıkları ve Göğüs Cerrahisi Eğitim ve Araştırma Hastanesi

location_facility: Niepubliczny Specjalistyczny ZOZ Puls-Med s.c.

location_facility: Kirikkale Universitesi Tip Fakultesi Hastanesi

location_facility: Central PA Asth & Allergy Care; Research Division

location_facility: Nouvel Hôpital Civil; Pôle de Pathologie Thoracique

location_facility: Izmir Dr. Suat Seren Gogus Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

location_facility: Ninewells Hospital; Asthma and Allergy Research Group

location_facility: Russian Uni of People'S Friendship, Med. Faculty; City Clinical Hospital No 64, Internal Diseases

location_facility: Yanovskyy Inst of Phth. & Pulm; Clinical-functional

location_facility: Instituto Jalisciense de Investigacion Clinica S.A. de C.V.

location_facility: Centre d'investigation Clinique Mauricie

location_facility: Allergy & Asthma Medical Group & Research Center, Pc

location_facility: Danylo Halytskyy National Medical University; Lviv

location_facility: Box Hill Hospital; Eastern Clinical Research Unit

location_facility: Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

location_facility: Japan Community Health Care Organization Hokkaido Hospital

location_facility: Florida Pulmonary Research Institute, LLC

location_facility: Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

location_facility: Allergy & Asthma Research Center of El Paso

location_facility: Tehelná Clinic, Inc; IMUNO-ALERGO, s. r.o.

location_facility: Barzilai Medical Center; Pulmonary Inst.

location_facility: St-Petersburg Diagnostic Ctr#1; Pulmonology

location_facility: Regional Phthisiology and Pulmonology Center

location_facility: Educational Scientific Medical Centre of Donetsk National Medical University;

location_facility: Grazyna Pulka Specjalistyczny Ośrodek ALL-MED

location_facility: Hospital Dr Angel Leaño universidad Autonoma de Guadalajara AC

location_facility: Turgut Ozal Universitesi Tip Fakultesi Bestepe Hastanesi

location_facility: Central Outpatient Hospital of Desnyansky District

location_facility: Central Clinical Hospital #1 of RZhD JCS

location_facility: Tosei General Hospital; Respiratory and Allergy Medicine

location_facility: Uludag University; Pulmonology and Allergy Department

location_facility: Municipal Institution of Health Care "Yevpatoriya City Hospital №1

location_facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

location_facility: Centro de Investigaciones Medicas Respiratorias

location_facility: National Hospital Organization Mito Medical Center

location_facility: Specjalistyczne Centrum Medyczne NOWOMED

location_facility: Laporte County Institute For Clinical Research

location_facility: St.-Petersburg SMU n. a. Academician I.P.Pavlov; Therapy Department

location_facility: The Lung Institute of Western Australia; Sir Charles Gairdner Hospital

location_facility: Castle Hill Hospital; Respiratory Medicine

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

location_facility: Pharmaceutical Research & Consulting, Inc.

location_facility: Canakkale Onsekiz Mart Universitesi Tip Fakultesi Hastanesi

location_facility: Dokkyo Medical University Koshigaya Hospital

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: St. Petersburg State Budget Medical Institution Pokrovskaya City Hospital

location_facility: Investigaciones en Patologias Respiratorias

location_facility: Seoul National University Bundang Hospital

location_facility: Prywatna Praktyka Lekarska Gabinet Pediatryczno-Alergologiczny

location_facility: Northeast Medical Research Associates, Inc

location_facility: Centrum Medycyny Oddechowej Robert M. Mróz

location_facility: Klinika Chorób Wewnetrznych i Alergologii MSW

location_facility: CHU Nantes - Hôpital Laennec; Service de Pneumologie

location_facility: Clinical Research Inst. of Southern Oregon, Pc

location_facility: Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova

location_facility: SI Dept. Clin. Hospital of Zaporizhzhia-2 Railway Station of SE Prydniprovska Zaliznytsia

location_facility: Prof.Dr.Octavian Fodor Emergency Clinical Hospital

location_facility: St James University Hospital; Respiratory Department

location_facility: Clinical Hospital Center ''Bezanijska Kosa''; Department of Pulmology

location_facility: Medical and Sanitary Unit of OJSC "Kharkiv Tractor Plant n.a. Ordzhonikidze"; Department of Therapy

location_facility: Grand View Hospital; Clinical Research Department

location_facility: St. Francis Sleep; Allergy & Lung Institute

location_facility: Allergy & Asthma Diagnostic; Treatment Center

location_facility: Lady Davis Carmel Medical Center; Cardiovascular Medicine

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

location_facility: Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

location_facility: Small Business Private Enterprise Medical Centre Pulse

location_facility: St. Paul's Hospital, The Catholic University of Korea, College of Medicine

location_facility: Fondazione Salvatore Maugeri. IRCCS - Divisione di Pneumologia

location_facility: A.o. Universitaria Pisana; Dipartimento Cardio Toracico


acronym: DIMENSION

lead_sponsor: Bristol-Myers Squibb

summary: To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

ReferenceCitation: Nelson M, Rubio R, Lazzarin A, Romanova S, Luetkemeyer A, Conway B, Molina JM, Xu D, Srinivasan S, Portsmouth S. Safety and Efficacy of Pegylated Interferon Lambda, Ribavirin, and Daclatasvir in HCV and HIV-Coinfected Patients. J Interferon Cytokine Res. 2017 Mar;37(3):103-111. doi: 10.1089/jir.2016.0082. Epub 2017 Feb 17.

publisher_dissemination: Mary Ann Liebert Inc

location_facility: Emory Hospital Midtown Infectious Disease Clinic

location_facility: Vancouver Id Reserach & Care Centre Society

location_facility: Mcgill University Health Centre (Muhc) Montreal Chest Institute

location_facility: University Of Colorado Denver & Hospital

title: Phase 3 Open Label Study Evaluating the Efficacy and Safety of Pegylated Interferon Lambda-1a, in Combination With Ribavirin and Daclatasvir, for Treatment of Chronic HCV Infection With Treatment naïve Genotypes 1, 2, 3 or 4 in Subjects Co-infected With HIV

design_allocation: Non-Randomized

location_country:
Germany
Italy
Poland
United Kingdom
Argentina
Mexico
Belgium
United States
Spain
Canada
Russian Federation
France


acronym: ASTRAEA

summary: The purpose of this study is to compare subcutaneous Abatacept to placebo in the treatment of psoriatic arthritis

ReferenceCitation: McInnes IB, Ferraccioli G, D'Agostino MA, Le Bars M, Banerjee S, Ahmad HA, Elbez Y, Mease PJ. Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial. RMD Open. 2019 May 30;5(1):e000934. doi: 10.1136/rmdopen-2019-000934. eCollection 2019.

repository_institution: Università Cattolica del Sacro Cuore - PubliCatt

repositories_institution: The University of Glasgow - Enlighten: Publications

ReferenceCitation: Strand V, Alemao E, Lehman T, Johnsen A, Banerjee S, Ahmad HA, Mease PJ. Improved patient-reported outcomes in patients with psoriatic arthritis treated with abatacept: results from a phase 3 trial. Arthritis Res Ther. 2018 Dec 6;20(1):269. doi: 10.1186/s13075-018-1769-7.

ReferenceCitation: Mease PJ, Gottlieb AB, van der Heijde D, FitzGerald O, Johnsen A, Nys M, Banerjee S, Gladman DD. Efficacy and safety of abatacept, a T-cell modulator, in a randomised, double-blind, placebo-controlled, phase III study in psoriatic arthritis. Ann Rheum Dis. 2017 Sep;76(9):1550-1558. doi: 10.1136/annrheumdis-2016-210724. Epub 2017 May 4.

repository_institution: University of Oxford - Oxford Academic Notes & Queries

location_facility: Arthritis Asso & Osteo Ctr Of Colorado Springs

location_facility: Groupe De Recherche En Rhumatologie Et Maladies Osseuses

location_facility: Arizona Arthritis & Rheumatology Research PLLC

location_facility: Hospital Nacional Guillermo Almenara Irigoyen

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Clinical Research Center Of Reading, Llc

location_facility: Instituto De Ginecologia Y Reproduccion Inv. Clinical Sac

location_facility: Toronto Western Hospital, University Health Network

location_facility: Box Arthritis And Rheumatology Of The Carolinas, Pllc

location_facility: Paramount Medical Research & Consulting, Llc

title: A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis

location_country:
Germany
Italy
Poland
Colombia
Israel
Argentina
Brazil
Mexico
United States
Spain
Greece
South Africa
Chile
Czechia
Canada
Peru
France


intervention_type: Biological

summary: The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA

ReferenceCitation: Ruperto N, Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Cimaz R, Dare J, Espada G, Faugier E, Ferrandiz M, Gerloni V, Quartier P, Silva CA, Wagner-Weiner L, Gandhi Y, Passarell J, Nys M, Wong R, Martini A, Lovell DJ; Pediatric Rheumatology Collaborative Study Group (PRCSG) and the Paediatric Rheumatology International Trials Organisation (PRINTO). Absence of Association Between Abatacept Exposure and Initial Infection in Patients With Juvenile Idiopathic Arthritis. J Rheumatol. 2021 Jul;48(7):1073-1081. doi: 10.3899/jrheum.200154. Epub 2021 Jan 15.

publisher_dissemination: The Journal of Rheumatology

ReferenceCitation: Brunner HI, Tzaribachev N, Cornejo GV, Joos R, Gervais E, Cimaz R, Calvo Penades I, Cuttica R, Lutz T, Quartier P, Gandhi Y, Nys M, Wong R, Martini A, Lovell DJ, Ruperto N; Pediatric Rheumatology Collaborative Study Group and the Paediatric Rheumatology International Trials Organisation. Maintenance of antibody response to diphtheria/tetanus vaccine in patients aged 2-5 years with polyarticular-course juvenile idiopathic arthritis receiving subcutaneous abatacept. Pediatr Rheumatol Online J. 2020 Feb 22;18(1):19. doi: 10.1186/s12969-020-0410-x.

repository_institution: Universita Degli Studi Di Milano - Archivio Istituzionale della Ricerca

repositories_concat: PubMed Central;air.unimi.it

ReferenceCitation: Brunner HI, Tzaribachev N, Vega-Cornejo G, Louw I, Berman A, Calvo Penades I, Anton J, Avila-Zapata F, Cuttica R, Horneff G, Foeldvari I, Keltsev V, Kingsbury DJ, Viola DO, Joos R, Lauwerys B, Paz Gastanaga ME, Rama ME, Wouters C, Bohnsack J, Breedt J, Fischbach M, Lutz T, Minden K, Miraval T, Ally MMTM, Rubio-Perez N, Solau Gervais E, van Zyl R, Li X, Nys M, Wong R, Banerjee S, Lovell DJ, Martini A, Ruperto N; Paediatric Rheumatology International Trials Organisation (PRINTO) and the Pediatric Rheumatology Collaborative Study Group (PRCSG). Subcutaneous Abatacept in Patients With Polyarticular-Course Juvenile Idiopathic Arthritis: Results From a Phase III Open-Label Study. Arthritis Rheumatol. 2018 Jul;70(7):1144-1154. doi: 10.1002/art.40466. Epub 2018 May 20.

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repository_institution: University of Pretoria - UpSpace Institutional Repository

repository_institution: Universidad Autónoma de Nuevo León - El Repositorio Academico Digital de la UANL

repositories_concat: LIRIAS (KU Leuven);PubMed Central;air.unimi.it;eprints.uanl.mx;repository.up.ac.za

location_facility:
Local Institution - 0017
Local Institution - 0029
Local Institution - 0030
Local Institution - 0031
Local Institution - 0057
Local Institution - 0003
Local Institution - 0018
Local Institution - 0011
Local Institution - 0009
Local Institution - 0041
Local Institution - 0035
Local Institution - 0059
Local Institution - 0044
Local Institution - 0015
Local Institution - 0027
Local Institution - 0007
Local Institution - 0055
Local Institution - 0002
Local Institution - 0040
Local Institution - 0032
Local Institution - 0058
Local Institution - 0038
Local Institution - 0028
Local Institution - 0064
Local Institution - 0005
Local Institution - 0014
Local Institution - 0061
Local Institution - 0034
Local Institution - 0052
Local Institution - 0037
Local Institution - 0016
Local Institution - 0068
Local Institution - 0062
Local Institution - 0033
Local Institution - 0001
Local Institution - 0022
Local Institution - 0008
Local Institution
Local Institution - 0047
Local Institution - 0049
Local Institution - 0045
Local Institution - 0004
Local Institution - 0056
Local Institution - 0025
Local Institution - 0026
Local Institution - 0048
Local Institution - 0050
Local Institution - 0053
Local Institution - 0060
Riley Hospital For Children
University Of Kansas Medical Center
Local Institution - 0046
Local Institution - 0036
Local Institution - 0042
Seattle Children'S Hospital

title: A Phase 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)

location_country:
Germany
Italy
Argentina
Brazil
Mexico
Belgium
United States
Spain
South Africa
Peru
Russian Federation
France


title: A STUDY OF NERATINIB PLUS CAPECITABINE VERSUS LAPATINIB PLUS CAPECITABINE IN PATIENTS WITH HER2+ METASTATIC BREAST CANCER WHO HAVE RECEIVED TWO OR MORE PRIOR HER2-DIRECTED REGIMENS IN THE METASTATIC SETTING (NALA)

acronym: NALA

summary: This is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of neratinib plus capecitabine versus the combination of lapatinib plus capecitabine in HER2+ MBC patients who have received two or more prior HER2 directed regimens in the metastatic setting.

ReferenceCitation: Dai MS, Feng YH, Chen SW, Masuda N, Yau T, Chen ST, Lu YS, Yap YS, Ang PCS, Chu SC, Kwong A, Lee KS, Ow S, Kim SB, Lin J, Chung HC, Ngan R, Kok VC, Rau KM, Sangai T, Ng TY, Tseng LM, Bryce R, Bebchuk J, Chen MC, Hou MF. Analysis of the pan-Asian subgroup of patients in the NALA Trial: a randomized phase III NALA Trial comparing neratinib+capecitabine (N+C) vs lapatinib+capecitabine (L+C) in patients with HER2+metastatic breast cancer (mBC) previously treated with two or more HER2-directed regimens. Breast Cancer Res Treat. 2021 Oct;189(3):665-676. doi: 10.1007/s10549-021-06313-5. Epub 2021 Sep 23.

repository_institution: Research Square - Research Square

repository_normalized: Research Square

repositories:
PubMed Central
Research Square

repositories_concat: PubMed Central;Research Square

ReferenceCitation: Saura C, Oliveira M, Feng YH, Dai MS, Chen SW, Hurvitz SA, Kim SB, Moy B, Delaloge S, Gradishar W, Masuda N, Palacova M, Trudeau ME, Mattson J, Yap YS, Hou MF, De Laurentiis M, Yeh YM, Chang HT, Yau T, Wildiers H, Haley B, Fagnani D, Lu YS, Crown J, Lin J, Takahashi M, Takano T, Yamaguchi M, Fujii T, Yao B, Bebchuk J, Keyvanjah K, Bryce R, Brufsky A; NALA Investigators. Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in HER2-Positive Metastatic Breast Cancer Previously Treated With >/= 2 HER2-Directed Regimens: Phase III NALA Trial. J Clin Oncol. 2020 Sep 20;38(27):3138-3149. doi: 10.1200/JCO.20.00147. Epub 2020 Jul 17.

repository_institution: California Digital Library - eScholarship

repositories:
LIRIAS (KU Leuven)
PubMed Central
escholarship.org

repositories_concat: LIRIAS (KU Leuven);PubMed Central;escholarship.org

repositories_institution: California Digital Library - eScholarship

ipd_sharing: Yes

ipd_sharing_description:
Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.

lead_sponsor: Puma Biotechnology, Inc.

location_country:
Finland
Germany
Ireland
Argentina
Australia
Brazil
Japan
Turkey
Czechia
Canada
France
Portugal
Hong Kong
Denmark
Switzerland
United States
Belgium
Italy
United Kingdom
Singapore
Sweden
Netherlands
Austria
Korea, Republic of
Spain
Taiwan
Russian Federation
Israel

location_facility: South Lyon Hospital Center, Department of Clinical Hematology and Medical Oncology

location_facility: Maroondah Hospital, Maroondah Breast Clinic

location_facility: Uppsala University Hospital, Department of Oncology

location_facility: Cancer Center of Santa Barbara Sansum Clinic

location_facility: Liga Paranaense de Combate ao Cancer, Hospital Erasto Gaertner

location_facility: Johns Hopkins Singapore International Medical Center

location_facility: National Hospital Organization Osaka National Hospital

location_facility: University Hospital Quiron Madrid, Department of Oncology

location_facility: Hospital Cervesi di Cattolica, Department of Oncology

location_facility: Cancer Care Associates Medical Group, Inc

location_facility: Hospital Clinico Universitario Lozano Blesa, Servicio de Oncologia

location_facility: Hakuaikai Medical Corporation Sagara Hospital

location_facility: Instituto de Pesquisas Clinicas para Estudos Multicentricos Hospital Geral de Caxias do Sul, Universidade de Caxias do Sul (IPCEM)

location_facility: University Hospital Motol, Comprehensive Oncology Center

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins at Greenspring Station

location_facility: Sunnybrook Health Sciences Center, Odette Cancer Center

location_facility: Nottingham City Hospital Campus, Department of Oncology

location_facility: Queen Mary Hospital, Department of Oncology

location_facility: University Hospital Innsbruck - Tyrolean Hospital, Department of Gynecology

location_facility: Consorcio Hospitalario Provincial de Castellon

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: National Hospital Organization Hokkaido Cancer Center

location_facility: Institute of Cancer Research and Treatment

location_facility: Ensino E Terapia de Inovação Clínica Assistência Multidiciplinar Em Oncologia Ética

location_facility: Emory University Winship Cancer Institute

location_facility: University of Texas Southwestern Medical Center

location_facility: Helsinki University Central Hospital, Department of Oncology

location_facility: Hospital Infermi Rimini, Unit of Oncology

location_facility: Kobe City Medical Center General Hospital

location_facility: Hospital Sacro Cuore Don Calabria, Department of Medical Oncology

location_facility: Instituto Portugues de Oncologia de Lisboa Francisco Gentil, EPE

location_facility: University Hospitals Cleveland Medical Center

location_facility: Sourasky Medical Center, Department of Oncology

location_facility: National Cancer Institute - IRCCS "Fondazione G. Pascale"

location_facility: North Shore Hematology Oncology Association PC

location_facility: Clinic Sainte Anne, Center for Radiotherapy

location_facility: Gleneagles Medical Centre, Center for Medical Oncology

location_facility: Otto von Guericke University of Magdeburg

location_facility: Compassionate Cancer Care Medical Group Inc.

location_facility: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

location_facility: Institut Jules Bordet - Medical Oncology

location_facility: University Hospital Cologne, Breast Center, Clinic of Obstetrics and Gynecology

location_facility: Icon Singapore Oncology Consultants Farrer Park Medical Clinic

location_facility: Hospital Clinico Universitario de Valencia, Servicio de Oncologia

location_facility: North Shore Oncology-Hematology Associates, Ltd.

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

location_facility: Hospital Son Llatzer, Servicio de Oncologia

location_facility: Calderdale Royal Hospital, Macmillan Unit

location_facility: University Hospital Clinic San Carlos, Servicio de Oncologia Medica

location_facility: Centro de Investigação Clinica, Hospital da Luz

location_facility: Hospital Do Cancer A C Camargo - Hospital

location_facility: University of California San Diego Moores Cancer Center

location_facility: University Hospital 12 de Octubre, Servicio de Oncologia - Edificio Maternidad, 2ª planta

location_facility: Centre hospitalier affilié universitaire de Québec - Hôpital du Saint-Sacrement

location_facility: Queen Mary Hospital, Department of Surgery

location_facility: Instituto Português de Oncologia do Porto Francisco Gentil, E.P.E.

location_facility: The Cancer Institute at University of Maryland St. Joseph Medical Center

location_facility: Scientific Institute of Romagna of the Study and Treatment of Cancer

location_facility: Kaplan Medical Center, Department of Oncology

location_facility: Orebro University Hospital, Department of Oncology

location_facility: Queen Elizabeth Hospital, Department of Clinical Oncology

location_facility: COIBA Centro de Oncología e Investigación Buenos Aires

location_facility: Federal State Government-Financed Institution: City Clinical Hospital #40

location_facility: Instituto Joinvillense de Hematologia e Oncologia

location_facility: Hospital Araújo Jorge, Associação de Combate ao Câncer em Goiás

location_facility: Hospital de Cancer de Barretos - Hospital

location_facility: National Cancer Centre Singapore, Department of Medical Oncology

location_facility: Hospital Universitario Virgen de la Arrixaca, Servicio de Oncologia

location_facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto, Hospital de Base

location_facility: Complejo Hospitalario Universitario Insular-Materno Infantil

location_facility: Queen Mary Hospital, Department of Clinical Oncology

location_facility: IRCCS - Hospital San Raffaele, Department of Medical Oncology

location_facility: Instituto Ribeiraopretano de Combate Ao Cancer - Clinic/Outpatient Facility

location_facility: Instituto Brasileiro de Controle Do Câncer IBCC

location_facility: Hospital Universitari de Girona Dr. Josep Trueta (ICO Girona), Servicio de Oncologia

location_facility: Maastricht University Medical Centre (MUMC)

location_facility: University Hospitals Case Medical Center

location_facility: AZ Damiaan General Hospital, Sint-Jozef Oncology Center

location_facility: Abbotsford Regional Hospital and Cancer Care Centre

location_facility: Gustave Roussy Oncology Institute, Department of Medicine

location_facility: Hospital Papa Giovanni XXIII, Department of Medical Oncology

location_facility: Russian Oncological Research Center n.a. N.N. Blokhin Russian Academy of Medical Sciences

location_facility: Chi Mei Medical Center - LiouYing Branch

location_facility: Taichung Veterans General Hospital, Breast Center

location_facility: University Hospital Virgen del Rocio, Servicio de Oncologia

location_facility: Hospital Desio and Vimercate, Department of Medical Oncology

location_facility: University of California San Diego Medical Center - Hillcrest


title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism in Subjects With Chronic Kidney Disease on Hemodialysis

summary: This study is designed to assess the efficacy and safety of etelcalcetide compared with placebo in the treatment of SHPT in patients with chronic kidney disease (CKD) receiving hemodialysis.

ReferenceCitation: Block GA, Bushinsky DA, Cunningham J, Drueke TB, Ketteler M, Kewalramani R, Martin KJ, Mix TC, Moe SM, Patel UD, Silver J, Spiegel DM, Sterling L, Walsh L, Chertow GM. Effect of Etelcalcetide vs Placebo on Serum Parathyroid Hormone in Patients Receiving Hemodialysis With Secondary Hyperparathyroidism: Two Randomized Clinical Trials. JAMA. 2017 Jan 10;317(2):146-155. doi: 10.1001/jama.2016.19456.

ReferenceCitation: Kroenke MA, Weeraratne DK, Deng H, Sloey B, Subramanian R, Wu B, Serenko M, Hock MB. Clinical immunogenicity of the d-amino acid peptide therapeutic etelcalcetide: Method development challenges and anti-drug antibody clinical impact assessments. J Immunol Methods. 2017 Jun;445:37-44. doi: 10.1016/j.jim.2017.03.005. Epub 2017 Mar 6.

ReferenceCitation: Stollenwerk B, Iannazzo S, Akehurst R, Adena M, Briggs A, Dehmel B, Parfrey P, Belozeroff V. A Decision-Analytic Model to Assess the Cost-Effectiveness of Etelcalcetide vs. Cinacalcet. Pharmacoeconomics. 2018 May;36(5):603-612. doi: 10.1007/s40273-017-0605-2.

ReferenceCitation: Stollenwerk B, Iannazzo S, Cooper K, Belozeroff V. Exploring the potential value of improved care for secondary hyperparathyroidism with a novel calcimimetic therapy. J Med Econ. 2017 Oct;20(10):1110-1115. doi: 10.1080/13696998.2017.1360309. Epub 2017 Aug 14.

ReferenceCitation: Chen P, Narayanan A, Wu B, Gisleskog PO, Gibbs JP, Chow AT, Melhem M. Population Pharmacokinetic and Pharmacodynamic Modeling of Etelcalcetide in Patients with Chronic Kidney Disease and Secondary Hyperparathyroidism Receiving Hemodialysis. Clin Pharmacokinet. 2018 Jan;57(1):71-85. doi: 10.1007/s40262-017-0550-4.

ReferenceCitation: Block GA, Chertow GM, Sullivan JT, Deng H, Mather O, Tomlin H, Serenko M. An integrated analysis of safety and tolerability of etelcalcetide in patients receiving hemodialysis with secondary hyperparathyroidism. PLoS One. 2019 Mar 15;14(3):e0213774. doi: 10.1371/journal.pone.0213774. eCollection 2019.

ReferenceCitation: Cunningham J, Block GA, Chertow GM, Cooper K, Evenepoel P, Iles J, Sun Y, Urena-Torres P, Bushinsky DA. Etelcalcetide Is Effective at All Levels of Severity of Secondary Hyperparathyroidism in Hemodialysis Patients. Kidney Int Rep. 2019 Apr 16;4(7):987-994. doi: 10.1016/j.ekir.2019.04.010. eCollection 2019 Jul.

ReferenceCitation: Wolf M, Block GA, Chertow GM, Cooper K, Fouqueray B, Moe SM, Sun Y, Tomlin H, Vervloet M, Oberbauer R. Effects of etelcalcetide on fibroblast growth factor 23 in patients with secondary hyperparathyroidism receiving hemodialysis. Clin Kidney J. 2019 Apr 26;13(1):75-84. doi: 10.1093/ckj/sfz034. eCollection 2020 Feb.

ReferenceCitation: Hain D, Tomlin H, Gibson C. Administration of Etelcalcetide for the Treatment of Secondary Hyperparathyroidism in Patients with CKD-MBD on Hemodialysis: A Nephrology Nursing Perspective. Nephrol Nurs J. 2019 May-Jun;46(3):315-290.

lead_sponsor: Amgen

location_country:
Germany
Italy
Poland
Hungary
Israel
United Kingdom
Australia
Austria
Belgium
United States
Spain
Czechia
Canada
Russian Federation
France


title: An Adaptive Phase II Study to Evaluate the Efficacy, Pharmacodynamics, Safety and Tolerability of GSK2586184 in Patients With Mild to Moderate Systemic Lupus Erythematosus

summary:
This is an adaptive, dose ranging, Phase II study to investigate the relationship between repeat doses of GSK2586184 and the pharmacodynamic effect and clinical efficacy in patients with active systemic lupus erythematosus (SLE). This study will also investigate the safety and tolerability of repeat doses of GSK2586184. During the study, up to 3 Interim Analyses will be conducted. These are to monitor the pharmacodynamic effect and safety following 2 weeks of therapy (Interim Analysis 1); and the clinical efficacy and safety of GSK2586184 following 12 weeks of therapy (Interim Analyses 2 and 3). Subjects who meet the entry criteria (approximately 150 to 250) will be randomized in a 1:1:1:1:1 ratio to receive GSK2586184 at doses of 50 milligram (mg) twice daily (b.i.d), 100 mg b.i.d, 200 mg b.i.d, 400 mg b.i.d or Placebo b.i.d. GSK2586184 tablets available in 50 and 200 mg dose strength will be administered orally up to 12 weeks.

Subjects who complete the study will participate in the study for approximately 21 weeks.

ReferenceCitation: Kahl L, Patel J, Layton M, Binks M, Hicks K, Leon G, Hachulla E, Machado D, Staumont-Salle D, Dickson M, Condreay L, Schifano L, Zamuner S, van Vollenhoven RF; JAK115919 Study Team. Safety, tolerability, efficacy and pharmacodynamics of the selective JAK1 inhibitor GSK2586184 in patients with systemic lupus erythematosus. Lupus. 2016 Nov;25(13):1420-1430. doi: 10.1177/0961203316640910. Epub 2016 Jul 11.

publisher_dissemination: SAGE Publications

ipd_sharing_description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

lead_sponsor: GlaxoSmithKline

location_country:
Germany
Poland
Hungary
Argentina
Hong Kong
Romania
Sweden
Korea, Republic of
Spain
Greece
South Africa
Chile
Czechia
Estonia
Peru
France


type: Other Grant/Funding Number

type: U.S. NIH Grant/Contract

type: Registry Identifier

title: A Phase II/III Multicenter Randomized, Double-Blind, Placebo-Controlled Platform Trial of Potential Disease Modifying Therapies Utilizing Biomarker, Cognitive, and Clinical Endpoints in Dominantly Inherited Alzheimer's Disease

acronym: DIAN-TU

summary: The purpose of this study is to assess the safety, tolerability, biomarker, cognitive and clinical efficacy of investigational products in participants with an Alzheimer's disease-causing mutation by determining if treatment with the study drug slows the rate of progression of cognitive/clinical impairment or improves disease-related biomarkers.

ReferenceCitation: Bateman RJ, Xiong C, Benzinger TL, Fagan AM, Goate A, Fox NC, Marcus DS, Cairns NJ, Xie X, Blazey TM, Holtzman DM, Santacruz A, Buckles V, Oliver A, Moulder K, Aisen PS, Ghetti B, Klunk WE, McDade E, Martins RN, Masters CL, Mayeux R, Ringman JM, Rossor MN, Schofield PR, Sperling RA, Salloway S, Morris JC; Dominantly Inherited Alzheimer Network. Clinical and biomarker changes in dominantly inherited Alzheimer's disease. N Engl J Med. 2012 Aug 30;367(9):795-804. doi: 10.1056/NEJMoa1202753. Epub 2012 Jul 11. Erratum In: N Engl J Med. 2012 Aug 23;367(8):780.

ReferenceCitation: Farlow M, Arnold SE, van Dyck CH, Aisen PS, Snider BJ, Porsteinsson AP, Friedrich S, Dean RA, Gonzales C, Sethuraman G, DeMattos RB, Mohs R, Paul SM, Siemers ER. Safety and biomarker effects of solanezumab in patients with Alzheimer's disease. Alzheimers Dement. 2012 Jul;8(4):261-71. doi: 10.1016/j.jalz.2011.09.224. Epub 2012 Jun 5.

ReferenceCitation: Bateman RJ, Benzinger TL, Berry S, Clifford DB, Duggan C, Fagan AM, Fanning K, Farlow MR, Hassenstab J, McDade EM, Mills S, Paumier K, Quintana M, Salloway SP, Santacruz A, Schneider LS, Wang G, Xiong C; DIAN-TU Pharma Consortium for the Dominantly Inherited Alzheimer Network. The DIAN-TU Next Generation Alzheimer's prevention trial: Adaptive design and disease progression model. Alzheimers Dement. 2017 Jan;13(1):8-19. doi: 10.1016/j.jalz.2016.07.005. Epub 2016 Aug 29.

ReferenceCitation: Mills SM, Mallmann J, Santacruz AM, Fuqua A, Carril M, Aisen PS, Althage MC, Belyew S, Benzinger TL, Brooks WS, Buckles VD, Cairns NJ, Clifford D, Danek A, Fagan AM, Farlow M, Fox N, Ghetti B, Goate AM, Heinrichs D, Hornbeck R, Jack C, Jucker M, Klunk WE, Marcus DS, Martins RN, Masters CM, Mayeux R, McDade E, Morris JC, Oliver A, Ringman JM, Rossor MN, Salloway S, Schofield PR, Snider J, Snyder P, Sperling RA, Stewart C, Thomas RG, Xiong C, Bateman RJ. Preclinical trials in autosomal dominant AD: implementation of the DIAN-TU trial. Rev Neurol (Paris). 2013 Oct;169(10):737-43. doi: 10.1016/j.neurol.2013.07.017. Epub 2013 Sep 6.

ReferenceCitation: Wang G, Berry S, Xiong C, Hassenstab J, Quintana M, McDade EM, Delmar P, Vestrucci M, Sethuraman G, Bateman RJ; Dominantly Inherited Alzheimer Network Trials Unit. A novel cognitive disease progression model for clinical trials in autosomal-dominant Alzheimer's disease. Stat Med. 2018 Sep 20;37(21):3047-3055. doi: 10.1002/sim.7811. Epub 2018 May 14.

ReferenceCitation: Weninger S, Carrillo MC, Dunn B, Aisen PS, Bateman RJ, Kotz JD, Langbaum JB, Mills SL, Reiman EM, Sperling R, Santacruz AM, Tariot PN, Welsh-Bohmer KA. Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement. 2016 May;12(5):631-2. doi: 10.1016/j.jalz.2016.04.001. No abstract available.

ReferenceCitation: Grill JD, Bateman RJ, Buckles V, Oliver A, Morris JC, Masters CL, Klunk WE, Ringman JM; Dominantly Inherited Alzheimer's Network. A survey of attitudes toward clinical trials and genetic disclosure in autosomal dominant Alzheimer's disease. Alzheimers Res Ther. 2015 Jul 22;7(1):50. doi: 10.1186/s13195-015-0135-0. eCollection 2015.

ReferenceCitation: McDade E, Bateman RJ. Stop Alzheimer's before it starts. Nature. 2017 Jul 12;547(7662):153-155. doi: 10.1038/547153a. No abstract available.

ReferenceCitation: McDade E, Wang G, Gordon BA, Hassenstab J, Benzinger TLS, Buckles V, Fagan AM, Holtzman DM, Cairns NJ, Goate AM, Marcus DS, Morris JC, Paumier K, Xiong C, Allegri R, Berman SB, Klunk W, Noble J, Ringman J, Ghetti B, Farlow M, Sperling RA, Chhatwal J, Salloway S, Graff-Radford NR, Schofield PR, Masters C, Rossor MN, Fox NC, Levin J, Jucker M, Bateman RJ; Dominantly Inherited Alzheimer Network. Longitudinal cognitive and biomarker changes in dominantly inherited Alzheimer disease. Neurology. 2018 Oct 2;91(14):e1295-e1306. doi: 10.1212/WNL.0000000000006277. Epub 2018 Sep 14.

ReferenceCitation: Ryman DC, Acosta-Baena N, Aisen PS, Bird T, Danek A, Fox NC, Goate A, Frommelt P, Ghetti B, Langbaum JB, Lopera F, Martins R, Masters CL, Mayeux RP, McDade E, Moreno S, Reiman EM, Ringman JM, Salloway S, Schofield PR, Sperling R, Tariot PN, Xiong C, Morris JC, Bateman RJ; Dominantly Inherited Alzheimer Network. Symptom onset in autosomal dominant Alzheimer disease: a systematic review and meta-analysis. Neurology. 2014 Jul 15;83(3):253-60. doi: 10.1212/WNL.0000000000000596. Epub 2014 Jun 13.

ReferenceCitation: Weng H, Bateman R, Morris JC, Xiong C. Validity and power of minimization algorithm in longitudinal analysis of clinical trials. Biostat Epidemiol. 2017;1(1):59-77. doi: 10.1080/24709360.2017.1331822. Epub 2017 Jun 13.

ipd_sharing_description: Access to DIAN-TU trial data will follow the DIAN-TU data access policy, which complies with the guidelines established by the Collaboration for Alzheimer's Prevention [CAP REF].

lead_sponsor: Washington University School of Medicine

collaborators: Accelerating Medicines Partnership (AMP)

location_country:
Germany
Ireland
Italy
Colombia
United Kingdom
Argentina
Australia
Brazil
Japan
Mexico
Netherlands
United States
Spain
Canada
Puerto Rico
France

location_facility: Grupo de Neurociencias Sede de la Universidad de Antioquia

location_facility: University of California San Diego Medical Center

location_facility: Instituto de Investigaciones Neurologicas Raul Carrea, FLENI

location_facility: The McCuster Foundation of Alzheimer's Disease Research

location_facility: Hospital das Clínicas da Faculdade de Medicina da USP

location_facility: CHU de Quebec - Hôpital de l' Enfant Jésus

location_facility: IRCCS Centro San Giovanni di Dio Fatebenefratelli

location_facility: Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez

location_facility: University of Puerto Rico, School of Medicine

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: The National Hospital for Neurology and Neurosurgery

location_facility: Hospital Clínic I Provincial de Barcelona

lead_sponsor_type: academique


title: A Pivotal Phase 2b/3, Multicentre, Randomised, Open, Controlled Study on the Efficacy and Safety of Autologous Osteoblastic Cells (PREOB®) Implantation in Non-Infected Hypotrophic Non-Union Fractures

summary:
Fracture healing is a complex physiological process caused by interaction of cellular elements, cytokines and signaling proteins, which results in the formation of new bone (Gerstenfeld et al., 2003). Depending on fracture site, complexity, co-morbidities and other factors, 10% of all fractures will eventually fail to unite.

Non-union fractures are defined as fractures that are at least six to nine months old and in which there have been no signs of healing for the last three months. Various causes have been evoked for impaired healing in hypotrophic (atrophic and oligotrophic) non-unions, including poor fracture stabilization, local infection and failure of the osteoblastic cells to multiply. Currently the treatment of choice for non-unions, particularly atrophic non-unions, is bone autograft (or allograft), combined or not with intramedullary nailing, plating, and external fixation devices (Kanakaris et al., 2007). This procedure produces good results but requires an invasive surgery of several hours under general anesthesia and a few days of hospitalization. Because of this, major complications have been reported in up to 20-30% of patients (Pieske et al., 2009, Zimmerman et al., 2009).

This Phase 2b/3 study aims at demonstrating the safety and efficacy of PREOB®, a proprietary population of autologous osteoblastic cells, in the treatment of hypotrophic non-union fractures of long bones. PREOB® will be compared to Bone Autograft in a non-inferiority design.

lead_sponsor: Bone Therapeutics S.A

location_country: Netherlands Belgium France

location_facility:
Investigating site BE06
Investigating site FR04
Investigating site BE03
Investigating site FR06
Investigating site FR03
Investigating site NL02
Investigating site FR02
Investigating site BE02
Investigating site BE04
Investigating site BE01
Investigating site BE08
Investigating site NL01
Investigating site FR01
Investigating site BE05
Investigating site BE09
Investigating site BE07


title: Study NOG112264, a Phase II Study of Ozanezumab (GSK1223249) Versus Placebo in the Treatment of Amyotrophic Lateral Sclerosis

summary: This is a 48-week, randomised, multi-centre, double-blind, placebo-controlled, parallel group investigation of the efficacy and safety of intravenous (IV) ozanezumab (GSK1223249) compared to placebo in subjects with Amyotrophic Lateral Sclerosis (ALS). Following a screening period of up to four weeks, eligible subjects will be randomised (1:1) to receive IV placebo or 15 milligram (mg)/ kilogram (kg) IV ozanezumab every 2 weeks for a period of 48 weeks with a follow-up visit around 14 weeks after the last infusion. A total of approximately 294 eligible subjects will be randomised from approximately 37 centers worldwide. The primary objective is to assess the effect of ozanezumab on the physical function and survival of ALS subjects over a treatment period of 48 weeks. Function will be measured using the ALS Functional Rating Scale - Revised (ALSFRS-R). Secondary objectives include the evaluation of other clinical outcomes associated with ALS (respiratory function, muscle strength, progression free survival and overall survival) in support of the primary objective. Quality of life, safety, tolerability, immunogenicity and pharmacokinetics (ozanezumab and riluzole) will also be assessed.

ReferenceCitation: Meininger V, Genge A, van den Berg LH, Robberecht W, Ludolph A, Chio A, Kim SH, Leigh PN, Kiernan MC, Shefner JM, Desnuelle C, Morrison KE, Petri S, Boswell D, Temple J, Mohindra R, Davies M, Bullman J, Rees P, Lavrov A; NOG112264 Study Group. Safety and efficacy of ozanezumab in patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Neurol. 2017 Mar;16(3):208-216. doi: 10.1016/S1474-4422(16)30399-4. Epub 2017 Jan 28.

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

repository_institution: University of Southampton - ePrints Soton

location_country:
Germany
Italy
United Kingdom
Australia
Japan
Netherlands
Belgium
United States
Korea, Republic of
Canada
France


title: Phase 1b/2, Multicenter, Open-label Trial to Evaluate the Safety and Efficacy of Talimogene Laherparepvec and Ipilimumab Compared to Ipilimumab Alone in Subjects With Unresected, Stage IIIB-IV Melanoma

summary: Phase 1b of the study will evaluate the safety of talimogene laherparepvec in combination with ipilimumab. Phase 2 is a randomized study that will evaluate the safety and efficacy of talimogene laherparepvec in combination with ipilimumab versus ipilumumab alone.

ReferenceCitation: Chesney J, Puzanov I, Collichio F, Singh P, Milhem MM, Glaspy J, Hamid O, Ross M, Friedlander P, Garbe C, Logan TF, Hauschild A, Lebbe C, Chen L, Kim JJ, Gansert J, Andtbacka RHI, Kaufman HL. Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma. J Clin Oncol. 2018 Jun 10;36(17):1658-1667. doi: 10.1200/JCO.2017.73.7379. Epub 2017 Oct 5.

ReferenceCitation: Puzanov I, Milhem MM, Minor D, Hamid O, Li A, Chen L, Chastain M, Gorski KS, Anderson A, Chou J, Kaufman HL, Andtbacka RH. Talimogene Laherparepvec in Combination With Ipilimumab in Previously Untreated, Unresectable Stage IIIB-IV Melanoma. J Clin Oncol. 2016 Aug 1;34(22):2619-26. doi: 10.1200/JCO.2016.67.1529. Epub 2016 Jun 13.

ReferenceCitation: Chesney J, Puzanov I, Collichio F, Milhem MM, Hauschild A, Chen L, Sharma A, Garbe C, Singh P, Mehnert JM. Patterns of response with talimogene laherparepvec in combination with ipilimumab or ipilimumab alone in metastatic unresectable melanoma. Br J Cancer. 2019 Aug;121(5):417-420. doi: 10.1038/s41416-019-0530-6. Epub 2019 Jul 29.

ReferenceCitation: Dummer R, Hoeller C, Gruter IP, Michielin O. Combining talimogene laherparepvec with immunotherapies in melanoma and other solid tumors. Cancer Immunol Immunother. 2017 Jun;66(6):683-695. doi: 10.1007/s00262-017-1967-1. Epub 2017 Feb 25.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
United States
Germany
France


title: A Randomized, Open-label, Active-controlled Multi-center Study to Assess Safety of Uninterrupted Rivaroxaban vs. Usual Care in Subjects Undergoing Catheter Ablation Therapy for Atrial Fibrillation

acronym: VENTURE-AF

summary: The purpose of this exploratory study is to evaluate the safety of rivaroxaban and uninterrupted vitamin K antagonist (VKA) in adult participants with non-valvular atrial fibrillation (NVAF) who undergo catheter ablation as measured by post-procedure major bleeding events.

ReferenceCitation: Cappato R, Marchlinski FE, Hohnloser SH, Naccarelli GV, Xiang J, Wilber DJ, Ma CS, Hess S, Wells DS, Juang G, Vijgen J, Hugl BJ, Balasubramaniam R, De Chillou C, Davies DW, Fields LE, Natale A; VENTURE-AF Investigators. Uninterrupted rivaroxaban vs. uninterrupted vitamin K antagonists for catheter ablation in non-valvular atrial fibrillation. Eur Heart J. 2015 Jul 21;36(28):1805-11. doi: 10.1093/eurheartj/ehv177. Epub 2015 May 14.

repository_institution: PubMed Central - Europe PMC

evidence: oa repository (semantic scholar lookup)

repositories_concat: PubMed Central;pdfs.semanticscholar.org

publisher_dissemination: Oxford University Press

lead_sponsor: Janssen Scientific Affairs, LLC

sponsor_collaborators:
Janssen Scientific Affairs, LLC
Bayer

location_country:
Germany
United Kingdom
Belgium
United States
France


title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors

acronym: RA-BEACON

summary: The purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).

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.

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

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

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: Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8. Erratum In: Arthritis Res Ther. 2020 Jul 2;22(1):166.

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

repositories_concat: PubMed Central;eprints.whiterose.ac.uk

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.

evidence: open (via free pdf)

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: 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.

repositories_institution: University of Oxford - Oxford Academic Notes & Queries

ReferenceCitation: Genovese MC, Kremer JM, Kartman CE, Schlichting DE, Xie L, Carmack T, Pantojas C, Sanchez Burson J, Tony HP, Macias WL, Rooney TP, Smolen JS. Response to baricitinib based on prior biologic use in patients with refractory rheumatoid arthritis. Rheumatology (Oxford). 2018 May 1;57(5):900-908. doi: 10.1093/rheumatology/kex489.

ReferenceCitation: Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, Stoykov I, Rooney T, Bird P, Sanchez Burson JM, Genovese MC, Combe B. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017 Apr;76(4):694-700. doi: 10.1136/annrheumdis-2016-209821. Epub 2016 Oct 31.

ReferenceCitation: Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, Beattie SD, Koch AE, Cardillo TE, Rooney TP, Macias WL, de Bono S, Schlichting DE, Smolen JS. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247.

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.

location_country:
Germany
Poland
Argentina
Australia
Japan
Turkey
Canada
France
Denmark
Switzerland
United States
Belgium
Puerto Rico
Italy
United Kingdom
Netherlands
Austria
Mexico
Korea, Republic of
Spain
Greece
Israel

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.


lead_sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

summary: This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.

ReferenceCitation: Pierce CM, Zhang MH, Jonsson B, Iorga D, Cheruvu N, Balagtas CC, Steinhorn RH. Efficacy and Safety of IV Sildenafil in the Treatment of Newborn Infants with, or at Risk of, Persistent Pulmonary Hypertension of the Newborn (PPHN): A Multicenter, Randomized, Placebo-Controlled Trial. J Pediatr. 2021 Oct;237:154-161.e3. doi: 10.1016/j.jpeds.2021.05.051. Epub 2021 May 27.

location_facility: Neonatologia Fondazione IRCCS Policlinico San Matteo

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: OU Neonatal Intensive Care Unit at Children's Hospital

location_facility: Centre Hospitalier et Regional de Lille - Hopital Jeanne de Flandre

location_facility: Indiana University Health Methodist Hospital

location_facility: Glenfield Hospital, University Hospitals of Leicester NHS Trust

location_facility: The University of Oklahoma Health Sciences Center

location_facility: OU Follow-Up Program, PREMIEr Clinic, Children's Hospital

location_facility: Centre Hospitalier et Régional de Lille,

location_facility: Henry Zarrow Neonatal Intensive Care Unit, Children's Hospital at Saint Francis

location_facility: Great Ormond Street Hospital NHS Foundation Trust

location_facility: University of California Davis Medical Center

location_facility: Riley Hospital for Children at IU Health

location_facility: Hôpital de la Conception Assistance Publique-Hôpitaux de Marseille

location_facility: Radboud University Nijmegen Medical Centre

title: A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT

location_country:
Germany
Italy
Norway
United Kingdom
Denmark
Sweden
Netherlands
Belgium
United States
Spain
Canada
France


title: A Phase 1/2 Study of the Combination of Lirilumab (Anti-KIR) Plus Nivolumab (Anti-PD-1) or Lirilumab Plus Nivolumab and Ipilimumab in Advanced Refractory Solid Tumors

summary: To assess the safety and tolerability and preliminary anti-tumor activity of lirilumab (BMS-986015) given in combination with nivolumab (BMS-936558) and to identify dose limiting toxicities (DLTs) and the maximally tolerated dose (MTD) of the combination. In addition, to assess the combinations of lirilumab and nivolumab or lirilumab and nivolumab plus ipilimumab (BMS-734016) in subjects with advanced (metastatic and/or unresectable) refractory solid tumors.

location_country:
Italy
Switzerland
United States
Spain
Canada
France

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: The Ohio State University Wexner Medical Center

location_facility: University Of Texas Medical Branch Of Galveston

location_facility: Texas Oncology-Central Austin Cancer Center