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. 2021 Oct 27. pii: annrheumdis-2021-221276. doi: 10.1136/annrheumdis-2021-221276. [Epub ahead of print]

family: Taylor

full_name: Peter C Taylor

given: Peter C

family: Takeuchi

full_name: Tsutomu Takeuchi

given: Tsutomu

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Durez

full_name: Patrick Durez

given: Patrick

family: Smolen

full_name: Josef S Smolen

given: Josef S

family: Deberdt

full_name: Walter Deberdt

given: Walter

family: Issa

full_name: Maher Issa

given: Maher

family: Terres

full_name: Jorge Ross Terres

given: Jorge Ross

family: Bello

full_name: Natalia Bello

given: Natalia

family: Winthrop

full_name: Kevin L Winthrop

given: Kevin L

journal_name: Annals of the Rheumatic Diseases

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

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.

full_name: Alvin F. Wells

given: Alvin F.

family: Jia

full_name: Bochao Jia

given: Bochao

family: Xie

full_name: Li Xie

given: Li

family: Valenzuela

full_name: Guillermo J. Valenzuela

given: Guillermo J.

family: Keystone

full_name: Edward C. Keystone

given: Edward C.

family: Li

full_name: Zhanguo Li

given: Zhanguo

family: Quebe

full_name: Amanda K. Quebe

given: Amanda K.

family: Griffing

full_name: Kirstin Griffing

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.

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

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

name: University of Occupational and Environmental Health Japan Kitakyushu Japan

name: Botnar Research Centre and University of Oxford Oxford UK

name: Eli Lilly and Company Indianapolis Indiana

name: NIHR Leeds Musculoskeletal Biomedical Research Centre, Leeds Teaching Hospitals NHS Trust, and University of Leeds Leeds UK

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

repository_institution: The University of Glasgow - Enlighten: Publications

title: Characterization and Changes of Lymphocyte Subsets in Baricitinib‐Treated Patients With Rheumatoid Arthritis

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

repository_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.

name: Division of Immunology and Rheumatology, Stanford University Medical Center, Palo Alto, CA

name: Center for Rheumatology, Albany Medical College, Albany, NY

name: Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA

name: Latin Clinical Trial Center, San Juan, Puerto Rico

name: Rheumatology, Hospital Infanta Luisa, Sevilla, Spain

name: Department of Rheumatology and Clinical Immunology, University Hospital of Würzburg, Würzburg, Germany

name: Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria

ReferenceCitation: Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, Stoykov I, Rooney T, Bird P, Sánchez Bursón 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:
Greece
Australia
Belgium
Denmark
France
Japan
Poland
Argentina
Canada
Korea, Republic of
Switzerland
Netherlands
Puerto Rico
Germany
United States
United Kingdom
Italy
Austria
Mexico
Israel
Spain
Turkey

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.


ReferenceType: derived

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.

family: Pierce

full_name: Christine M. Pierce

given: Christine M.

sequence: first

family: Zhang

full_name: Min H. Zhang

given: Min H.

sequence: additional

family: Jonsson

full_name: Baldvin Jonsson

given: Baldvin

family: Iorga

full_name: Dinu Iorga

given: Dinu

family: Cheruvu

full_name: Narayan Cheruvu

given: Narayan

family: Balagtas

full_name: Cecile C. Balagtas

given: Cecile C.

family: Steinhorn

full_name: Robin H. Steinhorn

given: Robin H.

bso_classification: Medical research

datasource: user

genre: journal-article

genre_raw: journal-article

journal_name: The Journal of Pediatrics

publisher: Elsevier BV

publisher_dissemination: Elsevier

publisher_group: Elsevier

publisher_normalized: Elsevier

design_allocation: Randomized

intervention_type: Drug

status: Completed

study_start_date_type: Actual

study_type: Interventional

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.

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

enrollment_type: Actual

primary_purpose: Treatment

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

location_facility: Riley Hospital for Children at IU Health

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

location_facility: University of California Davis Medical Center

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

location_facility: Glenfield Hospital, University Hospitals of Leicester NHS Trust

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

location_facility: Neonatologia Fondazione IRCCS Policlinico San Matteo

location_facility: Indiana University Health Methodist Hospital

location_facility: The University of Oklahoma Health Sciences Center

location_facility: Radboud University Nijmegen Medical Centre

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Centre Hospitalier et Régional de Lille,

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

ipd_sharing: Yes

study_completion_date_type: Actual

type: EudraCT Number

source: euctr

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

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.

lead_sponsor_type: industriel

status_simplified: Completed


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.

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Switzerland
France
Spain
United States
Canada

location_facility: University Of Texas Medical Branch Of Galveston

location_facility: Sidney Kimmel Comprehensive Cancer Center At Johns Hopkins

location_facility: Texas Oncology-Central Austin Cancer Center

location_facility: The Ohio State University Wexner Medical Center

location_facility: Centre Hospitalier Universitaire Vaudois


ReferenceType: background

ReferenceCitation: Sands BE, Chen J, Feagan BG, Penney M, Rees WA, Danese S, Higgins PDR, Newbold P, Faggioni R, Patra K, Li J, Klekotka P, Morehouse C, Pulkstenis E, Drappa J, van der Merwe R, Gasser RA Jr. Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study. Gastroenterology. 2017 Jul;153(1):77-86.e6. doi: 10.1053/j.gastro.2017.03.049. Epub 2017 Apr 5.

lead_sponsor: AstraZeneca

location_country:
Italy
United States
France
Czechia
Poland
Hungary
Spain
Germany
Canada

title: A Phase 2a Study to Evaluate the Efficacy and Safety of MEDI2070 in Subjects With Moderate to Severe Crohn's Disease Who Have Failed or Are Intolerant to Anti-tumor Necrosis Factor-alpha Therapy

summary: The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection in open-label period


title: A Phase 1/2 Dose Escalation and Cohort Expansion Study of the Safety and Tolerability of Urelumab Administered in Combination With Nivolumab in Advanced/Metastatic Solid Tumors and B-cell Non-Hodgkins Lymphoma

summary: The purpose of this study is to determine which doses of Urelumab and Nivolumab are safe and tolerable when they are given together.

status: Terminated

location_country:
Germany
United States
France
Spain

location_facility: Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

intervention_type: Biological

status_simplified: Unknown


lead_sponsor: Janssen Research & Development, LLC

primary_purpose: Health Services Research

location_country:
Austria
South Africa
Philippines
Germany
France
Poland
Hungary
Argentina
Australia
Belgium
Russian Federation
United States
Canada
Taiwan

acronym: Long term Safety TOPAMAX monotherapy in pediatric patients

type: Other Identifier

title: A Randomized, Active-Controlled, Open-Label, Flexible-Dose Study to Assess the Safety and Tolerability of Topiramate as Monotherapy Compared With Levetiracetam as Monotherapy in Pediatric Subjects With New or Recent-Onset Epilepsy

summary: The purpose of this study is to evaluate the safety of topiramate monotherapy compared with levetiracetam another standard antiepileptic drug (AED), as monotherapy for new-onset or recent-onset epilepsy (seizure disorder) on pediatric growth and maturation, bone mineralization, and kidney stone formation in children aged 2 to 15 years.


title: A Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Followed by an Active Treatment Period, to Evaluate the Efficacy, Safety and Tolerability of Two Doses of Oral Administration of Laquinimod (0.6 mg/Day or 1.2 mg/Day) in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

acronym: CONCERTO

summary: This is a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study followed by active treatment, to evaluate the efficacy, safety and tolerability of two doses of oral administration of laquinimod in participants with RRMS. The study has 2 periods: Period 1, the double-blind, placebo-controlled period (up to 24 months) and Period 2, the active treatment period (24 months).

ReferenceCitation: Comi G, Dadon Y, Sasson N, Steinerman JR, Knappertz V, Vollmer TL, Boyko A, Vermersch P, Ziemssen T, Montalban X, Lublin FD, Rocca MA, Volkinshtein R, Rubinchick S, Halevy N, Filippi M. CONCERTO: A randomized, placebo-controlled trial of oral laquinimod in relapsing-remitting multiple sclerosis. Mult Scler. 2021 Aug 11:13524585211032803. doi: 10.1177/13524585211032803. [Epub ahead of print]

name: Vita-Salute San Raffaele University, Milan, Italy/Centro Sclerosi Multipla, Presidio Ospedaliero di Gallarate, Gallarate, Italy

family: Comi

full_name: Giancarlo Comi

given: Giancarlo

name: Teva Pharmaceutical Industries, Netanya, Israel

family: Dadon

full_name: Yuval Dadon

given: Yuval

family: Sasson

full_name: Nissim Sasson

given: Nissim

name: Teva Pharmaceutical Industries, Great Valley, PA, USA

family: Steinerman

full_name: Joshua R Steinerman

given: Joshua R

name: Heinrich-Heine Universität Düsseldorf, Düsseldorf, Germany

family: Knappertz

full_name: Volker Knappertz

given: Volker

family: Vollmer

full_name: Timothy L Vollmer

given: Timothy L

name: Pirogov Russian National Research University and Department of Neuroimmunology of the Federal Center of Cerebrovascular Pathology and Stroke, Moscow, Russia

family: Boyko

full_name: Alexey Boyko

given: Alexey

name: Univ. Lille, Inserm U1172 LilNCog, CHU Lille, FHU Precise, Lille, France

family: Vermersch

full_name: Patrick Vermersch

given: Patrick

name: Center of Clinical Neuroscience, University Hospital, Dresden, Germany

family: Ziemssen

full_name: Tjalf Ziemssen

given: Tjalf

name: Division of Neurology, St Michael’s Hospital, University of Toronto, Toronto, ON, Canada/Department of Neurology-Neuroimmunology, Centre d’Esclerosi Múltiple de Catalunya (Cemcat), Hospital Universitario Vall d’Hebron, Barcelona, Spain

family: Montalban

full_name: Xavier Montalban

given: Xavier

name: Icahn School of Medicine at Mount Sinai, New York, NY, USA

family: Lublin

full_name: Fred D Lublin

given: Fred D

family: Rocca

full_name: Maria A Rocca

given: Maria A

family: Volkinshtein

full_name: Rita Volkinshtein

given: Rita

family: Rubinchick

full_name: Svetlana Rubinchick

given: Svetlana

family: Halevy

full_name: Nitsan Halevy

given: Nitsan

name: Vita-Salute San Raffaele University, Milan, Italy/Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy/Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy/Neurorehabilitation Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy/Neurophysiology Service, IRCCS San Raffaele Scientific Institute, Milan, Italy

family: Filippi

full_name: Massimo Filippi

given: Massimo

journal_name: Multiple Sclerosis Journal

publisher: SAGE Publications

publisher_dissemination: SAGE Publications

publisher_group: SAGE Publications

publisher_normalized: SAGE Publications

lead_sponsor: Teva Branded Pharmaceutical Products R&D, Inc.

location_country:
North Macedonia
Greece
Romania
Belgium
Russian Federation
Ukraine
Spain
Croatia
France
Poland
Slovakia
Montenegro
Moldova, Republic of
Canada
Korea, Republic of
Bulgaria
Hungary
Germany
United States
United Kingdom
Italy
Austria
Bosnia and Herzegovina
Serbia
Czechia
Israel
Georgia
Belarus
Estonia
Latvia

location_facility:
Teva Investigational Site 80024
Teva Investigational Site 50124
Teva Investigational Site 32185
Teva Investigational Site 34017
Teva Investigational Site 10318
Teva Investigational Site 59062
Teva Investigational Site 10335
Teva Investigational Site 54041
Teva Investigational Site 53079
Teva Investigational Site 50135
Teva Investigational Site 58073
Teva Investigational Site 81016
Teva Investigational Site 32200
Teva Investigational Site 32197
Teva Investigational Site 53084
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Teva Investigational Site 53080
Teva Investigational Site 50125
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Teva Investigational Site 80023
Teva Investigational Site 53074
Teva Investigational Site 59046
Teva Investigational Site 68008
Teva Investigational Site 11013
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Teva Investigational Site 56006
Teva Investigational Site 53063
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Teva Investigational Site 30030
Teva Investigational Site 63028
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Teva Investigational Site 50131
Teva Investigational Site 52037
Teva Investigational Site 33014
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Teva Investigational Site 61022
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Teva Investigational Site 58078
Teva Investigational Site 87003
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Teva Investigational Site 53085
Teva Investigational Site 58085
Teva Investigational Site 10340
Teva Investigational Site 55007
Teva Investigational Site 51045
Teva Investigational Site 54048
Teva Investigational Site 30039
Teva Investigational Site 50142
Teva Investigational Site 30027
Teva Investigational Site 58077
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Teva Investigational Site 33013
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Teva Investigational Site 60011
Teva Investigational Site 30025
Teva Investigational Site 32177
Teva Investigational Site 53070
Teva Investigational Site 50144
Teva Investigational Site 52035
Teva Investigational Site 10324
Teva Investigational Site 55005
Teva Investigational Site 52048
Teva Investigational Site 65012
Teva Investigational Site 59044
Teva Investigational Site 53076
Teva Investigational Site 61017
Teva Investigational Site 54044
Teva Investigational Site 59058
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Teva Investigational Site 61019
Teva Investigational Site 32198
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Teva Investigational Site 32194
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Teva Investigational Site 35076
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Teva Investigational Site 32202
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Teva Investigational Site 37023
Teva Investigational Site 32203
Teva Investigational Site 32173
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Teva Investigational Site 10315
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Teva Investigational Site 50208
Teva Investigational Site 81015
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Teva Investigational Site 61014
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Teva Investigational Site 30035
Teva Investigational Site 59043
Teva Investigational Site 65011
Teva Investigational Site 32189
Teva Investigational Site 59059
Teva Investigational Site 61015
Teva Investigational Site 62013
Teva Investigational Site 58082
Teva Investigational Site 10350
Teva Investigational Site 30026
Teva Investigational Site 70006
Teva Investigational Site 10325
Teva Investigational Site 32176
Teva Investigational Site 58088
Teva Investigational Site 10329
Teva Investigational Site 54046
Teva Investigational Site 50136
Teva Investigational Site 59051
Teva Investigational Site 31030
Teva Investigational Site 54047
Teva Investigational Site 53073
Teva Investigational Site 31033
Teva Investigational Site 32182
Teva Investigational Site 59052
Teva Investigational Site 32186
Teva Investigational Site 59061
Teva Investigational Site 59057
Teva Investigational Site 52040
Teva Investigational Site 52039
Teva Investigational Site 30037
Teva Investigational Site 34010
Teva Investigational Site 35077
Teva Investigational Site 52050
Teva Investigational Site 31032
Teva Investigational Site 66002
Teva Investigational Site 50137
Teva Investigational Site 50139
Teva Investigational Site 53068
Teva Investigational Site 52046
Teva Investigational Site 52036
Teva Investigational Site 54043
Teva Investigational Site 54049
Teva Investigational Site 30032
Teva Investigational Site 30028
Teva Investigational Site 10339
Teva Investigational Site 50148
Teva Investigational Site 52038
Teva Investigational Site 30024
Teva Investigational Site 61016
Teva Investigational Site 58089
Teva Investigational Site 10348
Teva Investigational Site 32193
Teva Investigational Site 52043
Teva Investigational Site 10334
Teva Investigational Site 32181
Teva Investigational Site 59041
Teva Investigational Site 31031
Teva Investigational Site 53083
Teva Investigational Site 10331
Teva Investigational Site 58075
Teva Investigational Site 50143
Teva Investigational Site 59055
Teva Investigational Site 30023
Teva Investigational Site 33015
Teva Investigational Site 37024
Teva Investigational Site 52045
Teva Investigational Site 52042
Teva Investigational Site 54042
Teva Investigational Site 69006
Teva Investigational Site 53066
Teva Investigational Site 50132
Teva Investigational Site 31035
Teva Investigational Site 61026
Teva Investigational Site 50140
Teva Investigational Site 81018
Teva Investigational Site 10349
Teva Investigational Site 69008
Teva Investigational Site 62012
Teva Investigational Site 50133
Teva Investigational Site 10309
Teva Investigational Site 60009
Teva Investigational Site 63027
Teva Investigational Site 32174
Teva Investigational Site 50147
Teva Investigational Site 31034
Teva Investigational Site 65010
Teva Investigational Site 10343
Teva Investigational Site 10346
Teva Investigational Site 10311
Teva Investigational Site 30031
Teva Investigational Site 63024
Teva Investigational Site 59039
Teva Investigational Site 59053
Teva Investigational Site 32196
Teva Investigational Site 51046
Teva Investigational Site 53071
Teva Investigational Site 53064
Teva Investigational Site 54045
Teva Investigational Site 52044
Teva Investigational Site 50126
Teva Investigational Site 59045
Teva Investigational Site 52041
Teva Investigational Site 60010
Teva Investigational Site 10307
Teva Investigational Site 50134
Teva Investigational Site 31037
Teva Investigational Site 56005
Teva Investigational Site 58076
Teva Investigational Site 58081
Teva Investigational Site 68009
Teva Investigational Site 32201
Teva Investigational Site 59050
Teva Investigational Site 68011
Teva Investigational Site 32179
Teva Investigational Site 51043
Teva Investigational Site 11016
Teva Investigational Site 53072
Teva Investigational Site 50146
Teva Investigational Site 30034
Teva Investigational Site 58084
Teva Investigational Site 53069
Teva Investigational Site 81014
Teva Investigational Site 61021
Teva Investigational Site 11015
Teva Investigational Site 58087
Teva Investigational Site 58074
Teva Investigational Site 61025
Teva Investigational Site 52049
Teva Investigational Site 58086
Teva Investigational Site 32184
Teva Investigational Site 59060
Teva Investigational Site 55006
Teva Investigational Site 87001
Teva Investigational Site 34013
Teva Investigational Site 10332
Teva Investigational Site 35073
Teva Investigational Site 58115
Teva Investigational Site 10319
Teva Investigational Site 55008
Teva Investigational Site 34015
Teva Investigational Site 10330
Teva Investigational Site 50127
Teva Investigational Site 53067
Teva Investigational Site 59049
Teva Investigational Site 68010
Teva Investigational Site 61018
Teva Investigational Site 69009
Teva Investigational Site 32199
Teva Investigational Site 34011
Teva Investigational Site 52047
Teva Investigational Site 32195
Teva Investigational Site 59063
Teva Investigational Site 30040
Teva Investigational Site 34019
Teva Investigational Site 63025
Teva Investigational Site 63030
Teva Investigational Site 10310
Teva Investigational Site 31036
Teva Investigational Site 10317
Teva Investigational Site 50130
Teva Investigational Site 50128
Teva Investigational Site 58080
Teva Investigational Site 10313
Teva Investigational Site 33016
Teva Investigational Site 32190
Teva Investigational Site 68012
Teva Investigational Site 63026
Teva Investigational Site 59042


ReferenceCitation: Emery P, Burmester GR, Naredo E, Sinigaglia L, Lagunes I, Koenigsbauer F, Conaghan PG. Adalimumab dose tapering in patients with rheumatoid arthritis who are in long-standing clinical remission: results of the phase IV PREDICTRA study. Ann Rheum Dis. 2020 Aug;79(8):1023-1030. doi: 10.1136/annrheumdis-2020-217246. Epub 2020 May 13.

ReferenceCitation: Emery P, Burmester GR, Naredo E, Zhou Y, Hojnik M, Conaghan PG. Design of a phase IV randomised, double-blind, placebo-controlled trial assessing the ImPact of Residual Inflammation Detected via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) patients (PREDICTRA). BMJ Open. 2018 Feb 28;8(2):e019007. doi: 10.1136/bmjopen-2017-019007.

family: Emery

full_name: Paul Emery

given: Paul

family: Burmester

full_name: Gerd R Burmester

given: Gerd R

family: Naredo

full_name: Esperanza Naredo

given: Esperanza

family: Zhou

full_name: Yijie Zhou

given: Yijie

family: Hojnik

full_name: Maja Hojnik

given: Maja

family: Conaghan

full_name: Philip G Conaghan

given: Philip G

currency_apc_doaj: GBP

journal_name: BMJ Open

oa_colors: green gold

oa_host_type: publisher;repository

evidence: oa journal (via doaj)

host_type: publisher

license: cc-by-nc

license_normalized: cc-by-nc

version: publishedVersion

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

host_type: repository

repository_institution: PubMed Central - Europe PMC

repository_normalized: PubMed Central

evidence: oa repository (via pmcid lookup)

license_normalized: no license

publisher: BMJ

publisher_dissemination: British Medical Journal

publisher_group: British Medical Journal

publisher_normalized: British Medical Journal

title: Design of a phase IV randomised, double-blind, placebo-controlled trial assessing the ImPact ofResidual Inflammation Detected via Imaging TEchniques,Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab inClinical Remission Rheumatoid ArThritis (RA) patients (PREDICTRA)

intervention_type: Other

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

lead_sponsor: AbbVie

location_country:
Italy
Austria
United States
Sweden
Netherlands
Germany
France
Greece
Hungary
Australia
Ireland
Spain
Canada
United Kingdom

acronym: PREDICTRA

location_facility: North Georgia Rheumatology Grp /ID# 155225

location_facility: Fondazione IRCCS Policlinico /ID# 133886

location_facility: Hosp Sant J. Despi-Moises Brog /ID# 135368

location_facility: Hospital Universitario La Paz /ID# 135369

location_facility: North Mississippi Med Clinics /ID# 149443

location_facility: Orszagos Reumatologiai es Fizi /ID# 134710

location_facility: Mid Essex Hospitals NHS Trust /ID# 151636

location_facility: St Vincent's University Hosp /ID# 129210

location_facility: Hospital General Universitario Gregorio Maranon /ID# 133889

location_facility: CHU de Grenoble - Albet Michal /ID# 135953

location_facility: Hospital Universitario Basurto /ID# 135529

location_facility: University General Hospital "Attikon" /ID# 134709

location_facility: Azienda Istituto Gaetano Pini /ID# 132964

location_facility: Hospital Parc de Salut del Mar /ID# 148670

location_facility: Guy's and St Thomas' NHS Found /ID# 132965

location_facility: Hosp Clinico Virgen Arrixaca /ID# 137020

location_facility: Institut de Rhum. de Montreal /ID# 129055

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 149017

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 129142

location_facility: Low Country Rheumatology, PA /ID# 154198

location_facility: The Arthritis Program Res Grp /ID# 129056

location_facility: A.O.U.I. di Verona Policlinico /ID# 132973

location_facility: West Tennessee Research Inst /ID# 148391

location_facility: Debreceni Egyetem Klinikai Koz /ID# 134715

location_facility: Hosp General Univ de Valencia /ID# 134488

location_facility: A.O. Univ Consorziale Policlin /ID# 133932

location_facility: Royal Prince Alfred Hospital /ID# 154649

location_facility: Westlake Medical Research (WMR) Clinical Trials /ID# 155386

location_facility: Groupe de Recherche en Maladies Osseuses /ID# 129057

location_facility: Optimus Clinical Research Pty. /ID# 133881

title: A Phase 4 Trial Assessing the ImPact of Residual Inflammation Detected Via Imaging TEchniques, Drug Levels and Patient Characteristics on the Outcome of Dose TaperIng of Adalimumab in Clinical Remission Rheumatoid ArThritis (RA) Subjects (PREDICTRA)

summary: The primary objective of the study was to investigate the association between residual disease activity at Baseline as detected by Magnetic Resonance Imaging (MRI) and the occurrence of flares in participants with rheumatoid arthritis (RA) randomized to an adalimumab dose tapering regimen controlled by adalimumab withdrawal.


study_type: Observational

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Serbia
United Kingdom
Germany
Croatia
Bulgaria
France
Russian Federation
Spain
United States
Slovenia
Canada
Ukraine

time_perspective: Prospective

title: A 2-Month, Observational, Rollover Trial to Evaluate the Safety of Subjects With Agitation Associated With Dementia of the Alzheimer's Type Who Were Previously Treated With Brexpiprazole (OPC 34712) or Placebo in a Phase 3, Double-blind Trial

summary: To follow-up on the safety of subjects who were previously treated in a double-blind trial of brexpiprazole.


type: Registry Identifier

title: A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Multiple Rising Doses of MLN9708 for the Treatment of Subjects With ISN / RPS Class III or IV Lupus Nephritis

summary: The purpose of this study is to characterize the safety and tolerability of ixazomib when administered as multiple oral doses at escalating dose levels in participants with lupus nephritis.

ipd_sharing_description: Takeda makes patient-level, de-identified data sets and associated documents available after applicable marketing approvals and commercial availability have been received, an opportunity for the primary publication of the research has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com/Approach for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

lead_sponsor: Takeda

location_country:
Italy
United States
France
Russian Federation
Spain
Germany
United Kingdom


ReferenceCitation: Mahon FX, Boquimpani C, Kim DW, Benyamini N, Clementino NCD, Shuvaev V, Ailawadhi S, Lipton JH, Turkina AG, De Paz R, Moiraghi B, Nicolini FE, Dengler J, Sacha T, Takahashi N, Fellague-Chebra R, Acharya S, Wong S, Jin Y, Hughes TP. Treatment-Free Remission After Second-Line Nilotinib Treatment in Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Single-Group, Phase 2, Open-Label Study. Ann Intern Med. 2018 Apr 3;168(7):461-470. doi: 10.7326/M17-1094. Epub 2018 Feb 20.

name: University of Bordeaux, Bordeaux, France (F.M.)

family: Mahon

full_name: François-Xavier Mahon

given: François-Xavier

name: Hemocentro do Rio de Janeiro, HEMORIO, Rio de Janeiro, Brazil (C.B.)

family: Boquimpani

full_name: Carla Boquimpani

given: Carla

name: The Catholic University of Korea, Seoul, South Korea (D.K.)

family: Kim

full_name: Dong-Wook Kim

given: Dong-Wook

name: Rambam Health Care Campus, Haifa, Israel (N.B.)

family: Benyamini

full_name: Noam Benyamini

given: Noam

name: Hospital Das Clinicas da Universidade Federal de Minas Gerais, Belo Horizonte, Brazil (N.C.C.)

family: Clementino

full_name: Nelma Cristina D. Clementino

given: Nelma Cristina D.

name: Russian Research Institute of Hematology and Transfusiology, Saint Petersburg, Russia (V.S.)

family: Shuvaev

full_name: Vasily Shuvaev

given: Vasily

name: Mayo Clinic, Jacksonville, Florida (S.A.)

family: Ailawadhi

full_name: Sikander Ailawadhi

given: Sikander

name: University of Toronto, Toronto, Ontario, Canada (J.H.L.)

family: Lipton

full_name: Jeffrey Howard Lipton

given: Jeffrey Howard

name: National Research Center for Hematology, Moscow, Russia (A.G.T.)

family: Turkina

full_name: Anna G. Turkina

given: Anna G.

name: University Hospital La Paz, Madrid, Spain (R.D.)

family: De Paz

full_name: Raquel De Paz

given: Raquel

name: Hospital General De Agudos J. M. Ramos Mejia, Buenos Aires, Argentina (B.M.)

family: Moiraghi

full_name: Beatriz Moiraghi

given: Beatriz

name: Centre Hospitalier Lyon Sud, Pierre-Bénite, France (F.E.N.)

family: Nicolini

full_name: Franck E. Nicolini

given: Franck E.

name: Onkologische Praxis Heilbronn, Heilbronn, Germany (J.D.)

family: Dengler

full_name: Jolanta Dengler

given: Jolanta

name: Jagiellonian University Hospital, Kraków, Poland (T.S.)

family: Sacha

full_name: Tomasz Sacha

given: Tomasz

name: Akita University Hospital, Akita, Japan (N.T.)

family: Takahashi

full_name: Naoto Takahashi

given: Naoto

name: Novartis Pharma SAS, Rueil-Malmaison, France (R.F.)

family: Fellague-Chebra

full_name: Rafik Fellague-Chebra

given: Rafik

name: Novartis Healthcare Pvt Ltd, Hyderabad, India (S.A.)

family: Acharya

full_name: Sandip Acharya

given: Sandip

name: Novartis Oncology Precision Medicine, Cambridge, Massachusetts (S.W.)

family: Wong

full_name: Stephane Wong

given: Stephane

name: Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Y.J.)

family: Jin

full_name: Yu Jin

given: Yu

name: University of Adelaide, Adelaide, South Australia, Australia (T.P.H.)

family: Hughes

full_name: Timothy P. Hughes

given: Timothy P.

journal_name: Annals of Internal Medicine

publisher: American College of Physicians

publisher_dissemination: American College of Physicians

publisher_group: American College of Physicians

publisher_normalized: American College of Physicians

status: Active, not recruiting

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:
Brazil
Mexico
Spain
Germany
France
Japan
Greece
Israel
Korea, Republic of
Poland
Singapore
Belgium
Argentina
Australia
Russian Federation
United States
United Kingdom
Canada

acronym: ENESTop

location_facility: USC Kenneth Norris Comprehensive Cancer Center USC

study_completion_date_type: Anticipated

title: A Phase II, Single Arm, Open Label Study of Treatment-free Remission in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) Patients After Achieving Sustained MR4.5 on Nilotinib

summary: A clinical research study to find out if it is safe to stop the drug nilotinib (Tasigna) in chronic myeloid leukemia (CML) patients. Patients who started treatment with imatinib (Gleevec) when they were first diagnosed with CML, then switched to nilotinib (Tasigna) for at least 2 years with the combined time on imatinib (Gleevec) and nilotinib (Tasigna) for at least 3 years and have very small amount of leukemia cells remaining after the nilotinib (Tasigna) treatment will qualify for the study.


title: A Phase 1/2, First in Human, Dose Escalation Study of MGD006, a CD123 x CD3 DART® Bi-Specific Antibody Based Molecule, in Patients With Relapsed or Refractory AML or Intermediate-2/High Risk Myelodysplastic Syndrome (MDS)

summary: The primary objective of this study now is to assess the anti-neoplastic activity of flotetuzumab in patients with PIF/ER AML, as determined by the proportion of patients who achieve complete remission (CR) or complete remission with partial hematologic recovery (CRh).

status: Recruiting

enrollment_type: Anticipated

ReferenceCitation: Uy GL, Aldoss I, Foster MC, Sayre PH, Wieduwilt MJ, Advani AS, Godwin JE, Arellano ML, Sweet KL, Emadi A, Ravandi F, Erba HP, Byrne M, Michaelis L, Topp MS, Vey N, Ciceri F, Carrabba MG, Paolini S, Huls GA, Jongen-Lavrencic M, Wermke M, Chevallier P, Gyan E, Récher C, Stiff PJ, Pettit KM, Löwenberg B, Church SE, Anderson E, Vadakekolathu J, Santaguida M, Rettig MP, Muth J, Curtis T, Fehr E, Guo K, Zhao J, Bakkacha O, Jacobs K, Tran K, Kaminker P, Kostova M, Bonvini E, Walter RB, Davidson-Moncada JK, Rutella S, DiPersio JF. Flotetuzumab as salvage immunotherapy for refractory acute myeloid leukemia. Blood. 2021 Feb 11;137(6):751-762. doi: 10.1182/blood.2020007732.

name: Department of Medicine, School of Medicine, Washington University in St. Louis, St. Louis, MO;

family: Uy

full_name: Geoffrey L. Uy

given: Geoffrey L.

name: Gehr Family Center for Leukemia Research, City of Hope, Duarte, CA;

family: Aldoss

full_name: Ibrahim Aldoss

given: Ibrahim

name: Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC;

family: Foster

full_name: Matthew C. Foster

given: Matthew C.

name: Division of Hematology and Blood and Marrow Transplantation, University of California San Francisco, San Francisco, CA;

family: Sayre

full_name: Peter H. Sayre

given: Peter H.

name: Moores Cancer Center, University of California, San Diego, La Jolla, CA;

family: Wieduwilt

full_name: Matthew J. Wieduwilt

given: Matthew J.

name: Leukemia Program, Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH;

family: Advani

full_name: Anjali S. Advani

given: Anjali S.

name: Providence Cancer Institute, Portland, OR;

family: Godwin

full_name: John E. Godwin

given: John E.

name: Winship Cancer Institute, Emory University, Atlanta, GA;

family: Arellano

full_name: Martha L. Arellano

given: Martha L.

name: Department of Malignant Hematology, H. Lee Moffitt Cancer Center, Tampa, FL;

family: Sweet

full_name: Kendra L. Sweet

given: Kendra L.

name: Marlene & Stewart Greenebaum Cancer, School of Medicine, University of Maryland, Baltimore, MD;

family: Emadi

full_name: Ashkan Emadi

given: Ashkan

name: Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX;

family: Ravandi

full_name: Farhad Ravandi

given: Farhad

name: Division of Hematological Malignancies and Cellular Therapy, Department of Medicine, Duke University Medical Centre, Durham, NC;

family: Erba

full_name: Harry P. Erba

given: Harry P.

name: Division of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN;

family: Byrne

full_name: Michael Byrne

given: Michael

name: Division of Hematology/Oncology, Froedtert Hospital, Medical College of Wisconsin, Milwaukee, WI;

family: Michaelis

full_name: Laura Michaelis

given: Laura

name: Medizinische Klinik Und Poliklinik II, Universitätsklinikum Würzburg, Würzburg, Germany;

family: Topp

full_name: Max S. Topp

given: Max S.

name: Hematologie Clinique, Institut Paoli-Calmettes, Marseille, France;

family: Vey

full_name: Norbert Vey

given: Norbert

name: Hematology and Bone Marrow Transplantation Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Raffaele, Milan, Italy;

family: Ciceri

full_name: Fabio Ciceri

given: Fabio

family: Carrabba

full_name: Matteo Giovanni Carrabba

given: Matteo Giovanni

name: Department of Experimental, Diagnostic and Specialty Medicine, Institute of Hematology L. and A. Seràgnoli, University of Bologna, Bologna, Italy;

family: Paolini

full_name: Stefania Paolini

given: Stefania

name: Hematology, University Medical Center Groningen, Groningen, The Netherlands;

family: Huls

full_name: Gerwin A. Huls

given: Gerwin A.

name: Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands;

family: Jongen-Lavrencic

full_name: Mojca Jongen-Lavrencic

given: Mojca

name: Universitätsklinikum Carl Gustav Carus an der Technische Universität, Dresden, Germany;

family: Wermke

full_name: Martin Wermke

given: Martin

name: Institut Universitaire du Cancer Toulouse Oncopole, Centre Hospitalier Universitaire de Toulouse, Toulouse, France;

family: Chevallier

full_name: Patrice Chevallier

given: Patrice

name: Centre Hospitalier Universitaire de Nantes, Nantes, France;

family: Gyan

name: Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU) de Tours, Tours, France;

name: Loyola University Medical Center, Maywood, IL;

name: Michigan Medicine Bone Marrow Transplant and Leukemia, C. S. Mott Children’s Hospital, Ann Arbor, MI;

name: NanoString Technologies Inc, Seattle, WA;

name: John van Geest Cancer Research Centre, School of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom;

name: Fred Hutchinson Cancer Research Center, Seattle, WA; and

name: Centre for Health, Ageing and Understanding Disease (CHAUD), School of Science and Technology, Nottingham Trent University, Nottingham, United Kingdom

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

location_country:
Italy
United States
Netherlands
France
Germany
United Kingdom

location_facility: Unità Operativa di Ematologia Ospedale Santa Maria delle Croci

location_facility: Universitätsmedizin der Johannes Gutenberg-Universität Mainz

location_facility: Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden

location_facility: Washington University School of Medicine

location_facility: III. Med. Klinik-Klinikum rechts der Isar-Technische Universität München

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)

location_facility: University of North Carolina Lineberger Comprehensive Cancer Center

location_facility: Medizinische Klinik und II, Universitätsklinikum Würzburg

location_facility: Institut Universitaire du Cancer de Toulouse-Oncopole


title: A Double-Blind, Randomised, Placebo-Controlled, Multi-Centre Field Study to Assess the Efficacy and Safety of HDM-SPIRE in Subjects With a History of House Dust Mite-Induced Rhinoconjunctivitis

summary: The purpose of this study is to compare the treatment effect of three treatment regimens of HDM-SPIRE vs placebo and to evaluates the treatment effect of HDM-SPIRE on symptoms, rescue medication usage, Quality of Life and Sleep Quality

lead_sponsor: Circassia Limited

location_country:
Italy
United States
South Africa
Netherlands
France
Spain
Germany
Canada


ReferenceCitation: Van Cutsem E, Yoshino T, Lenz HJ, Lonardi S, Falcone A, Limón ML, Saunders M, Sobrero A, Park YS, Ferreiro R, Hong YS, Tomasek J, Taniguchi H, Ciardiello F, Stoehr J, Oum'Hamed Z, Vlassak S, Studeny M, Argiles G. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study. Ann Oncol. 2018 Sep 1;29(9):1955-1963. doi: 10.1093/annonc/mdy241.

family: Van Cutsem

full_name: E. Van Cutsem

given: E.

family: Yoshino

full_name: T. Yoshino

given: T.

family: Lenz

full_name: H.J. Lenz

family: Lonardi

full_name: S. Lonardi

given: S.

family: Falcone

full_name: A. Falcone

given: A.

family: Limón

full_name: M.L. Limón

family: Saunders

full_name: M. Saunders

given: M.

family: Sobrero

full_name: A. Sobrero

family: Park

full_name: Y.S. Park

family: Ferreiro

full_name: R. Ferreiro

given: R.

family: Hong

full_name: Y.S. Hong

family: Tomasek

full_name: J. Tomasek

given: J.

family: Taniguchi

full_name: H. Taniguchi

given: H.

family: Ciardiello

full_name: F. Ciardiello

given: F.

family: Stoehr

full_name: J. Stoehr

family: Oum’Hamed

full_name: Z. Oum’Hamed

given: Z.

family: Vlassak

full_name: S. Vlassak

family: Studeny

full_name: M. Studeny

family: Argiles

full_name: G. Argiles

given: G.

journal_name: Annals of Oncology

oa_colors: green hybrid

evidence: open (via crossref license)

repository_institution: KU Leuven - Lirias

repository_normalized: LIRIAS (KU Leuven)

repositories_institution:
KU Leuven - Lirias
PubMed Central - Europe PMC

ReferenceCitation: Van Cutsem E, Yoshino T, Hocke J, Oum'Hamed Z, Studeny M, Tabernero J. Rationale and Design for the LUME-Colon 1 Study: A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Nintedanib Plus Best Supportive Care Versus Placebo Plus Best Supportive Care in Patients With Advanced Colorectal Cancer Refractory to Standard Treatment. Clin Colorectal Cancer. 2016 Mar;15(1):91-94.e1. doi: 10.1016/j.clcc.2015.09.005. Epub 2015 Oct 9.

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

location_facility: 1199.52.3501 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3305 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8109 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1003 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8801 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8112 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3521 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6103 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6104 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3205 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9004 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8106 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8110 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6105 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9002 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3901 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3307 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8202 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8805 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3103 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3402 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3504 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9003 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3404 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8501 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3401 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8114 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8116 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3304 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8104 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3206 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1001 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4402 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4502 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0121 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4302 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8107 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4602 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3905 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4504 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3301 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4405 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0115 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5401 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4501 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8105 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3102 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4503 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4906 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8102 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4403 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8802 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3207 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4202 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4904 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0120 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4804 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4404 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5406 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8803 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3406 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0113 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3204 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4903 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4303 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5404 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0105 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4803 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1002 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3506 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3502 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3403 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3407 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0119 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8115 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3906 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9704 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4601 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3202 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6102 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3203 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0703 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4401 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3903 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8111 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9703 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4901 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4801 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0106 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0123 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8108 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3208 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5403 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3904 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8101 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3405 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0108 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0104 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8113 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4304 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.5405 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.6106 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0114 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8503 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9001 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9706 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8502 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0102 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4201 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.9005 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8103 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4204 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0702 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.4905 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8504 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3505 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0707 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0125 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8203 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.8204 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.3907 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.1004 Boehringer Ingelheim Investigational Site

location_facility: 1199.52.0701 Boehringer Ingelheim Investigational Site

title: A Double-blind, Randomised, Placebo Controlled Phase III Study of Nintedanib Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Patients With Metastatic Colorectal Cancer Refractory to Standard Therapies.

summary: The objective of this Phase III study is to evaluate the efficacy of nintedanib in patients with metastatic colorectal cancer (mCRC) after failure of previous treatment with standard chemotherapy and biological agents.


title: A Phase 3 Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AMG0001 in Subjects With Critical Limb Ischemia

acronym: AGILITY

summary: Study to Evaluate the Efficacy and Safety of AMG0001 in Subjects with Critical Limb Ischemia.

lead_sponsor: AnGes USA, Inc.

location_country:
Italy
United States
Sweden
Netherlands
Finland
France
Poland
Hungary
Belgium
Denmark
Canada

location_facility: New York Presbyterian Hospital - Columbia University Medical Center

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Central Arkansas Veteran's Healthcare System

location_facility: Somogy Megyei Kaposi Mor Oktato Korhaz Altalanos- Mellkas es Ersebeszeti Osztaly

location_facility: San Francisco Veterans Affairs Medical Center

location_facility: Sarasota Memorial Hospital Clinical Research Center

location_facility: Szpital Uniwersytecki nr 1 im. Dr A. Jurasza w Bydgoszczy

location_facility: Karlkirurgiska Kliniken, Karolinska Universitetssjukhuset

location_facility: University of California, San Diego (UCSD)

location_facility: Bekes Megyei Pandy Kalman Korhaz Ersebeszet

location_facility: The Methodist Hospital Research Institute

location_facility: Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

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

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinika Központ

location_facility: SzSzB Megyei Korhazak es Egyetemi Oktatokorhaz

location_facility: Debreceni Egyetem Klinikai Kozpont, Belgyogyaszati Klinika

location_facility: Northwestern Medicine Central DuPage Hospital

location_facility: Universita Cattolica Policlinico Gemelli

location_facility: University of Oklahoma - Physicians Surgical Specialists

location_facility: CHU Amiens - Groupe Hospitalier Hopital Sud


title: Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793

summary: This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

ReferenceType: result

ReferenceCitation: Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.

family: Florian

full_name: Hana Florian

given: Hana

family: Meier

full_name: Andreas Meier

given: Andreas

name: McGill University Research Center for Studies in Aging, McGill University, Montreal, Quebec, Canada

family: Gauthier

full_name: Serge Gauthier

given: Serge

name: The Dr. Stanley Lipschitz Clinic, Rosebank, Johannesburg, South Africa

family: Lipschitz

full_name: Stanley Lipschitz

given: Stanley

family: Lin

full_name: Yunzhi Lin

given: Yunzhi

family: Tang

full_name: Qi Tang

given: Qi

name: Department of Pharmaceutics, Faculty of Pharmacy, Cairo University, Cairo, Egypt

family: Othman

full_name: Ahmed A. Othman

given: Ahmed A.

family: Robieson

full_name: Weining Z. Robieson

given: Weining Z.

family: Gault

full_name: Laura M. Gault

given: Laura M.

journal_name: Journal of Alzheimer's Disease

publisher: IOS Press

publisher_dissemination: IOS Press

publisher_group: IOS Press

publisher_normalized: IOS Press

title: Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer’s Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study

lead_sponsor: AbbVie (prior sponsor, Abbott)

location_country:
United States
South Africa
France
Greece
Germany
United Kingdom
Canada

location_facility:
Site Reference ID/Investigator# 84178
Site Reference ID/Investigator# 84391
Site Reference ID/Investigator# 84382
Site Reference ID/Investigator# 84375
Site Reference ID/Investigator# 84174
Site Reference ID/Investigator# 84380
Site Reference ID/Investigator# 84390
Site Reference ID/Investigator# 84376
Site Reference ID/Investigator# 84381
Site Reference ID/Investigator# 84182
Site Reference ID/Investigator# 84393
Site Reference ID/Investigator# 84181
Site Reference ID/Investigator# 84183
Site Reference ID/Investigator# 84389
Site Reference ID/Investigator# 84176
Site Reference ID/Investigator# 84399
Site Reference ID/Investigator# 84378
Site Reference ID/Investigator# 84374
Site Reference ID/Investigator# 84392
Site Reference ID/Investigator# 84187
Site Reference ID/Investigator# 84373
Site Reference ID/Investigator# 84394
Site Reference ID/Investigator# 84180
Site Reference ID/Investigator# 84173
Site Reference ID/Investigator# 84383
Site Reference ID/Investigator# 84398
Site Reference ID/Investigator# 84397
Site Reference ID/Investigator# 84179
Site Reference ID/Investigator# 84177
Site Reference ID/Investigator# 84385
Site Reference ID/Investigator# 84388
Site Reference ID/Investigator# 84400
Site Reference ID/Investigator# 84386
Site Reference ID/Investigator# 84379
Site Reference ID/Investigator# 84185
Site Reference ID/Investigator# 84186
Site Reference ID/Investigator# 84175
Site Reference ID/Investigator# 84377
Site Reference ID/Investigator# 84395


title: A Single Arm, Open-label, Phase 2 Study to Assess the Efficacy and Safety of Lucitanib Given Orally as a Single Agent to Patients With Advanced/Metastatic Lung Cancer and FGF, VEGF, or PDGF Related Genetic Alterations

summary: The purpose of this study is to determine whether lucitanib is safe and effective in the treatment of patients with advanced/metastatic lung cancer and fibroblast growth factor (FGF), vascular endothelial growth factor receptor (VEGF), or platelet derived growth factor (PDGF) related genetic alterations.

lead_sponsor: Clovis Oncology, Inc.

location_country:
Italy
United States
France
Spain
Germany

location_facility: Fondazione IRCCS Istituto Nazionale Tumori


ReferenceCitation: Neven P, Rugo HS, Tolaney SM, Iwata H, Toi M, Goetz MP, Kaufman PA, Lu Y, Haddad N, Hurt KC, Sledge GW Jr. Abemaciclib plus fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in premenopausal women: subgroup analysis from the MONARCH 2 trial. Breast Cancer Res. 2021 Aug 23;23(1):87. doi: 10.1186/s13058-021-01463-2.

family: Neven

full_name: Patrick Neven

given: Patrick

family: Rugo

full_name: Hope S. Rugo

given: Hope S.

family: Tolaney

full_name: Sara M. Tolaney

given: Sara M.

family: Iwata

full_name: Hiroji Iwata

given: Hiroji

family: Toi

full_name: Masakazu Toi

given: Masakazu

family: Goetz

full_name: Matthew P. Goetz

given: Matthew P.

family: Kaufman

full_name: Peter A. Kaufman

given: Peter A.

family: Lu

full_name: Yi Lu

given: Yi

family: Haddad

full_name: Nadine Haddad

given: Nadine

family: Hurt

full_name: Karla C. Hurt

given: Karla C.

family: Sledge

full_name: George W. Sledge

given: George W.

suffix: Jr.

journal_name: Breast Cancer Research

license: cc-by

license_normalized: cc-by

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

repository_institution: Research Square - Research Square

repository_normalized: Research Square

version: submittedVersion

repositories:
LIRIAS (KU Leuven)
PubMed Central
Research Square

repositories_institution:
KU Leuven - Lirias
Research Square - Research Square

publisher: Springer Science and Business Media LLC

publisher_dissemination: Springer-Nature

publisher_group: Springer-Nature

publisher_normalized: Springer

ReferenceCitation: Inoue K, Masuda N, Iwata H, Takahashi M, Ito Y, Miyoshi Y, Nakayama T, Mukai H, van der Walt JS, Mori J, Sakaguchi S, Kawaguchi T, Tanizawa Y, Llombart-Cussac A, Sledge GW Jr, Toi M. Japanese subpopulation analysis of MONARCH 2: phase 3 study of abemaciclib plus fulvestrant for treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that progressed on endocrine therapy. Breast Cancer. 2021 Sep;28(5):1038-1050. doi: 10.1007/s12282-021-01239-8. Epub 2021 Apr 1.

family: Inoue

full_name: Kenichi Inoue

given: Kenichi

family: Masuda

full_name: Norikazu Masuda

given: Norikazu

family: Takahashi

full_name: Masato Takahashi

given: Masato

family: Ito

full_name: Yoshinori Ito

ReferenceCitation: Goetz MP, Okera M, Wildiers H, Campone M, Grischke EM, Manso L, André VAM, Chouaki N, San Antonio B, Toi M, Sledge GW Jr. Safety and efficacy of abemaciclib plus endocrine therapy in older patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer: an age-specific subgroup analysis of MONARCH 2 and 3 trials. Breast Cancer Res Treat. 2021 Apr;186(2):417-428. doi: 10.1007/s10549-020-06029-y. Epub 2021 Jan 3.

ReferenceCitation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.

name: Stanford University School of Medicine, Stanford, California

name: Graduate School of Medicine, Kyoto University, Kyoto, Japan

name: Universitaire Ziekenhuizen Leuven, Leuven, Belgium

name: Centre Paul Strauss, INSERM 110, Strasbourg, France

name: Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russia

name: Adelaide Cancer Centre, Adelaide, Australia

name: National Hospital Organization, Osaka National Hospital, Osaka, Japan

name: University of Vermont Cancer Center, Burlington

name: Kaiser Permanente, Bellflower, California

name: Universitäts-Frauenklinik Tubingen, Eberhard Karls University, Tubingen, Germany

name: DiSCOG, University of Padova and Medical Oncology 2, Istituto Oncologico Veneto, Istituto di Ricovero e Cura a Carattere Scientifico, Padova, Italy

name: Eli Lilly and Company, Indianapolis, Indiana

name: The Royal Marsden NHS Foundation Trust, London, United Kingdom

name: Hospital Arnau Vilanova, Valencia, Spain

title: The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor–Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy—MONARCH 2

ReferenceCitation: Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Frenzel M, Lin Y, Barriga S, Smith IC, Bourayou N, Llombart-Cussac A. MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2- Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy. J Clin Oncol. 2017 Sep 1;35(25):2875-2884. doi: 10.1200/JCO.2017.73.7585. Epub 2017 Jun 3.

name: George W. Sledge Jr., Stanford University, Stanford; Han Koh, Kaiser Permanente Medical Group, Bellflower, CA; Masakazu Toi, Kyoto University; Kenichi Inoue, Saitama Cancer Center, Saitama; Norikazu Masuda, Osaka National Hospital, Osaka, Japan; Patrick Neven, Universitaire Ziekenhuizen Leuven – Campus Gasthuisberg, Leuven, Belgium; Joohyuk Sohn, Yonsei Cancer Center, Seoul, Korea; Xavier Pivot, CHU de Besancon Hopital Jean Minjoz, Besancon Cedex; Nawel Bourayou, Eli Lilly, Paris, France; Olga Burdaeva,...

publisher: American Society of Clinical Oncology (ASCO)

title: MONARCH 2: Abemaciclib in Combination With Fulvestrant in Women With HR+/HER2− Advanced Breast Cancer Who Had Progressed While Receiving Endocrine Therapy

ipd_sharing_description: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Italy
United States
Switzerland
Mexico
Spain
Germany
Finland
France
Japan
Greece
Poland
Romania
Belgium
Australia
Puerto Rico
Russian Federation
Denmark
Canada
Korea, Republic of
Taiwan

location_facility: Columbia University College of Phys & Surgeons

location_facility: Mount Sinai School of Medicine Dermatology Clinical Trials

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

location_facility: Oncology and Hematology Associates of Southwest Virginia Inc

location_facility: Southern California Permanente Medical Group

location_facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

location_facility: Novant Health, Oncology Research Institute

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

title: MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

summary:
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant.

For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.


title: A Double Blind, Placebo Controlled Two-part Study to Investigate the Dose-ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome

summary: To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.

ReferenceCitation: Devinsky O, Cross JH, Laux L, Marsh E, Miller I, Nabbout R, Scheffer IE, Thiele EA, Wright S; Cannabidiol in Dravet Syndrome Study Group. Trial of Cannabidiol for Drug-Resistant Seizures in the Dravet Syndrome. N Engl J Med. 2017 May 25;376(21):2011-2020. doi: 10.1056/NEJMoa1611618.

lead_sponsor: GW Research Ltd

location_country:
United States
United Kingdom
France
Poland


ReferenceCitation: Thangarajh M, Elfring GL, Trifillis P, McIntosh J, Peltz SW; Ataluren Phase 2b Study Group. The relationship between deficit in digit span and genotype in nonsense mutation Duchenne muscular dystrophy. Neurology. 2018 Sep 25;91(13):e1215-e1219. doi: 10.1212/WNL.0000000000006245. Epub 2018 Aug 22.

family: Thangarajh

full_name: Mathula Thangarajh

given: Mathula

family: Elfring

full_name: Gary L. Elfring

given: Gary L.

family: Trifillis

full_name: Panayiota Trifillis

given: Panayiota

family: McIntosh

full_name: Joseph McIntosh

given: Joseph

family: Peltz

full_name: Stuart W. Peltz

given: Stuart W.

name: on behalf of the Ataluren Phase 2b Study Group

journal_name: Neurology

oa_host_type: repository

publisher: Ovid Technologies (Wolters Kluwer Health)

publisher_dissemination: Wolters Kluwer Health

publisher_group: Wolters Kluwer Health

publisher_normalized: Wolters Kluwer Health

lead_sponsor: PTC Therapeutics

location_country:
Italy
Brazil
Chile
Sweden
Switzerland
Germany
France
Bulgaria
Czechia
Israel
Korea, Republic of
Poland
Belgium
Australia
Spain
Turkey
United States
United Kingdom
Canada

location_facility: Child Neurology Center of Northwest Florida

location_facility: Columbia University College of Physicians & Surgeons

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico di Milano

location_facility: U.O. Complessa di Neuropsichiatria Infantile

location_facility: Universitat Munchen - von Haunersche Kinder Clinic

location_facility: The Newcastle upon Tyne Hospitals, NHS Foundation Trust

location_facility: Children's Hospital Colorado - Center for Cancer and Blood Disorders

location_facility: Washington University School of Medicine, Division of Endocrinology, Metabolism and Lipid Research

location_facility: Hospital Universitari i Politecnic la Fe

location_facility: Seattle Children's Hospital - Childhood Cancer and Blood Disorders

location_facility: University College London Institute of Child Health

location_facility: Universidade Federal do Rio de Janeiro - Instituto de Puericultura e Pediatria Martagao Gesteira

ipd_sharing: No

title: A Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Dystrophinopathy

summary:
The primary objective of this study is to obtain long term safety data of ataluren in male participants with nonsense mutation dystrophinopathy (who participated and completed a previous Phase 3 study of ataluren [PTC124-GD-020-DMD {NCT01826487}]) to augment the overall safety database. Screening and baseline procedures are structured to avoid a gap in treatment between the double-blind study (PTC124-GD-020-DMD) and this extension study.

This study may be further extended by amendment until either ataluren becomes commercially available or the clinical development of ataluren in duchenne muscular dystrophy (DMD) is discontinued.


title: A Multicenter, Double-blind and Open Label, 4 Year Extension Study of Subcutaneous Secukinumab in Prefilled Syringes, Assessing Long-term Safety, Tolerability and Efficacy in Subjects With Moderate to Severe Chronic Plaque-type Psoriasis Treated With Either a Fixed Dose Regimen or on a Retreatment at Start of Relapse Regimen

summary: CAIN457A2304E1 was an extension study to two phase III studies, CAIN457A2304 and CAIN457A2307 (core studies). This extension study planned to collect up to four years of long-term safety, tolerability and efficacy data of secukinumab in both the fixed interval regimen and the retreatment at start of relapse regimen. All subjects who completed the full study treatment period (52 weeks) in the cores studies CAIN457A2304 and CAIN457A2307 were eligible to participate in this extension study. In this extension study, the prefilled syringe (PFS) liquid formulation of secukinumab was used.

design_allocation: Non-Randomized

ReferenceCitation: Bissonnette R, Luger T, Thaçi D, Toth D, Messina I, You R, Guana A, Fox T, Papavassilis C, Gilloteau I, Mrowietz U. Secukinumab sustains good efficacy and favourable safety in moderate-to-severe psoriasis after up to 3 years of treatment: results from a double-blind extension study. Br J Dermatol. 2017 Oct;177(4):1033-1042. doi: 10.1111/bjd.15706. Epub 2017 Sep 4.

name: Innovaderm Research Inc; Montréal QC Canada

family: Bissonnette

full_name: R. Bissonnette

given: R.

name: Department of Dermatology; University of Münster; Münster Germany

family: Luger

full_name: T. Luger

given: T.

name: Comprehensive Center for Inflammation Medicine; University Hospital Schleswig-Holstein; Lübeck Germany

family: Thaçi

full_name: D. Thaçi

given: D.

name: XLR8 Medical Research; Windsor ON Canada

family: Toth

full_name: D. Toth

name: Novartis Pharmaceuticals; East Hanover NJ U.S.A.

family: Messina

full_name: I. Messina

given: I.

name: Novartis Beijing Novartis Pharma Co. Ltd; Shanghai China

family: You

full_name: R. You

family: Guana

full_name: A. Guana

given: A.

family: Fox

full_name: T. Fox

family: Papavassilis

full_name: C. Papavassilis

given: C.

family: Gilloteau

full_name: I. Gilloteau

name: Psoriasis-Center; Department of Dermatology; University Medical Center Schleswig-Holstein; Kiel Germany

family: Mrowietz

full_name: U. Mrowietz

given: U.

journal_name: British Journal of Dermatology

oa_host_type: publisher

evidence: open (via free article)

publisher: Wiley

publisher_dissemination: Wiley

publisher_group: Wiley

publisher_normalized: Wiley

ipd_sharing: Undecided

location_country:
Italy
Austria
Switzerland
Vietnam
Germany
France
Czechia
Bulgaria
Japan
Poland
Singapore
Slovakia
United States
United Kingdom
Canada


title: An Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Dexpramipexole (BIIB050) in Subjects With Amyotrophic Lateral Sclerosis

acronym: ENVISION

summary: The purpose of the study is to collect long-term safety data from subjects with Amyotrophic Lateral Sclerosis (ALS) exposed to dexpramipexole.

lead_sponsor: Knopp Biosciences

location_country:
United States
Sweden
Netherlands
Germany
France
Ireland
Belgium
Australia
Spain
Canada
United Kingdom

location_facility: University of Texas Health Sciences Center

location_facility: Research Foundation of the State University of New York

location_facility: Kings College Hospital NHS Foundation Trust

location_facility: University of Miami Miller School of Medicine

location_facility: Washington University School of Medicine

location_facility: Sunnybrook and Women's College and Health Sciences Centre

location_facility: University of California at San Francisco - Fresno

location_facility: Walton Centre for Neurology & Neurosurgery

location_facility: Barrow Neurological Institute - St. Joseph's Hospital

location_facility: Johns Hopkins University School of Medicine

location_facility: Sheffield Institute for Transnational Neuroscience

location_facility: Newcastle University Hospital - Clinical Ageing Research Unit

location_facility: University of South Florida Medical Center


title: Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment. A 26-week Double-blind Placebo-controlled, Randomised, Multicentre, Multi-national, Parallel-group Trial

summary:
This trial is conducted in Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of liraglutide in subjects with type 2 diabetes and moderate renal impairment.

The trial medication will be add-on to the subject's stable pre-trial OAD and/or insulin regimen.

ReferenceCitation: Davies MJ, Bain SC, Atkin SL, Rossing P, Scott D, Shamkhalova MS, Bosch-Traberg H, Syrén A, Umpierrez GE. Efficacy and Safety of Liraglutide Versus Placebo as Add-on to Glucose-Lowering Therapy in Patients With Type 2 Diabetes and Moderate Renal Impairment (LIRA-RENAL): A Randomized Clinical Trial. Diabetes Care. 2016 Feb;39(2):222-30. doi: 10.2337/dc14-2883. Epub 2015 Dec 17.

family: Davies

full_name: Melanie J. Davies

given: Melanie J.

family: Bain

full_name: Stephen C. Bain

given: Stephen C.

family: Atkin

full_name: Stephen L. Atkin

given: Stephen L.

family: Rossing

full_name: Peter Rossing

given: Peter

family: Scott

full_name: David Scott

given: David

family: Shamkhalova

full_name: Minara S. Shamkhalova

given: Minara S.

family: Bosch-Traberg

full_name: Heidrun Bosch-Traberg

given: Heidrun

family: Syrén

full_name: Annika Syrén

given: Annika

family: Umpierrez

full_name: Guillermo E. Umpierrez

given: Guillermo E.

journal_name: Diabetes Care

oa_colors: green other

evidence: open (via free pdf)

repository_institution: Swansea University - Cronfa

version: acceptedVersion

publisher: American Diabetes Association

publisher_dissemination: American Diabetes Association

publisher_group: American Diabetes Association

publisher_normalized: American Diabetes Association

ReferenceCitation: Zobel EH, von Scholten BJ, Goldman B, Persson F, Hansen TW, Rossing P. Pleiotropic effects of liraglutide in patients with type 2 diabetes and moderate renal impairment: Individual effects of treatment. Diabetes Obes Metab. 2019 May;21(5):1261-1265. doi: 10.1111/dom.13638. Epub 2019 Feb 22.

name: Complications Research, Steno Diabetes Center Copenhagen Gentofte Denmark

family: Zobel

full_name: Emilie H. Zobel

given: Emilie H.

family: von Scholten

full_name: Bernt J. von Scholten

given: Bernt J.

family: Goldman

full_name: Bryan Goldman

given: Bryan

family: Persson

full_name: Frederik Persson

given: Frederik

family: Hansen

full_name: Tine W. Hansen

given: Tine W.

name: Department of Clinical Medicine, University of Copenhagen Copenhagen Denmark

journal_name: Diabetes, Obesity and Metabolism

repository_institution: University of Copenhagen - Research at the University of Copenhagen

ReferenceCitation: Kim JD, Park CY, Cha BY, Ahn KJ, Kim IJ, Park KS, Lee HW, Min KW, Won JC, Chung MY, Kim JT, Kang JG, Park SW. Comparison of Adherence to Glimepiride/Metformin Sustained Release Once-daily Versus Glimepiride/Metformin Immediate Release BID Fixed-combination Therapy Using the Medication Event Monitoring System in Patients With Type 2 Diabetes. Clin Ther. 2018 May;40(5):752-761.e2. doi: 10.1016/j.clinthera.2018.04.002. Epub 2018 May 3.

location_country:
France
Poland
Russian Federation
United States
United Kingdom
Ukraine


title: A Phase 2 Randomized Study to Investigate the Efficacy and Safety of LY2495655 Versus Placebo in Older Patients Who Have Fallen Recently and Have Muscle Weakness

summary: LY2495655 is an investigational drug being tested for muscle wasting.

ReferenceCitation: Becker C, Lord SR, Studenski SA, Warden SJ, Fielding RA, Recknor CP, Hochberg MC, Ferrari SL, Blain H, Binder EF, Rolland Y, Poiraudeau S, Benson CT, Myers SL, Hu L, Ahmad QI, Pacuch KR, Gomez EV, Benichou O; STEADY Group. Myostatin antibody (LY2495655) in older weak fallers: a proof-of-concept, randomised, phase 2 trial. Lancet Diabetes Endocrinol. 2015 Dec;3(12):948-57. doi: 10.1016/S2213-8587(15)00298-3. Epub 2015 Oct 27.

family: Becker

full_name: Clemens Becker

given: Clemens

family: Lord

full_name: Stephen R Lord

given: Stephen R

family: Studenski

full_name: Stephanie A Studenski

given: Stephanie A

family: Warden

full_name: Stuart J Warden

given: Stuart J

family: Fielding

full_name: Roger A Fielding

given: Roger A

family: Recknor

full_name: Christopher P Recknor

given: Christopher P

family: Hochberg

full_name: Marc C Hochberg

given: Marc C

family: Ferrari

full_name: Serge L Ferrari

given: Serge L

family: Blain

full_name: Hubert Blain

given: Hubert

family: Binder

full_name: Ellen F Binder

given: Ellen F

family: Rolland

full_name: Yves Rolland

given: Yves

family: Poiraudeau

full_name: Serge Poiraudeau

given: Serge

family: Benson

full_name: Charles T Benson

given: Charles T

family: Myers

full_name: Stephen L Myers

given: Stephen L

family: Hu

full_name: Leijun Hu

given: Leijun

family: Ahmad

full_name: Qasim I Ahmad

given: Qasim I

family: Pacuch

full_name: Kelli R Pacuch

given: Kelli R

family: Gomez

full_name: Elisa V Gomez

given: Elisa V

family: Benichou

full_name: Olivier Benichou

given: Olivier

journal_name: The Lancet Diabetes & Endocrinology

lead_sponsor: Eli Lilly and Company

location_country:
United States
Sweden
France
Argentina
Australia
Germany

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


title: A Phase 2, Double-blind, Placebo-controlled, Randomized Study to Evaluate the Safety, Tolerability, and Efficacy of KB003 in Subjects With Asthma Inadequately Controlled by Corticosteroids

summary: This study will evaluate the safety, tolerability and efficacy of a single dose level of KB003 in subjects with inadequately controlled asthma.

ReferenceCitation: Molfino NA, Kuna P, Leff JA, Oh CK, Singh D, Chernow M, Sutton B, Yarranton G. Phase 2, randomised placebo-controlled trial to evaluate the efficacy and safety of an anti-GM-CSF antibody (KB003) in patients with inadequately controlled asthma. BMJ Open. 2016 Jan 6;6(1):e007709. doi: 10.1136/bmjopen-2015-007709.

family: Molfino

full_name: Nestor A Molfino

given: Nestor A

family: Kuna

full_name: Piotr Kuna

given: Piotr

family: Leff

full_name: Jonathan A Leff

given: Jonathan A

family: Oh

full_name: Chad K Oh

given: Chad K

family: Singh

full_name: Dave Singh

given: Dave

family: Chernow

full_name: Marlene Chernow

given: Marlene

family: Sutton

full_name: Brian Sutton

given: Brian

family: Yarranton

full_name: Geoffrey Yarranton

given: Geoffrey

lead_sponsor: Humanigen, Inc.

location_country:
France
Poland
Australia
United States
United Kingdom
Ukraine


title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of Tabalumab in Combination With Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma

summary: The purpose of this study is to evaluate an investigational drug called tabalumab in participants with Multiple Myeloma (MM) who have tried at least one other therapy in the past. Tabalumab will be given in combination with standard doses of two other drugs that are often used to treat MM. Study doctors will collect information about the effectiveness and side effects of this therapy.

ipd_sharing_description:
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

location_country:
Italy
Brazil
Mexico
Netherlands
Germany
France
Korea, Republic of
Greece
Poland
Spain
Turkey
United States
United Kingdom
Canada
Taiwan


title: An Open Label, Randomized (2:1) Phase IIb Study of Dasatinib Versus Imatinib in Patients With Chronic Phase Chronic Myeloid Leukemia Who Have Not Achieved an Optimal Response to 3 Months of Therapy With 400 mg Imatinib

acronym: DASCERN

summary: The purpose of this study is to test the hypothesis that patients with CML who have not achieved optimal response after 3 months of treatment with imatinib will have a better response by switching to dasatinib compared to staying on their original imatinib regimen.

ReferenceCitation: Cortes JE, Jiang Q, Wang J, Weng J, Zhu H, Liu X, Hochhaus A, Kim DW, Radich J, Savona M, Martin-Regueira P, Sy O, Gurnani R, Saglio G. Dasatinib vs. imatinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) who have not achieved an optimal response to 3 months of imatinib therapy: the DASCERN randomized study. Leukemia. 2020 Aug;34(8):2064-2073. doi: 10.1038/s41375-020-0805-1. Epub 2020 Apr 7.

family: Cortes

full_name: Jorge E. Cortes

given: Jorge E.

family: Jiang

full_name: Qian Jiang

given: Qian

family: Wang

full_name: Jianxiang Wang

given: Jianxiang

family: Weng

full_name: Jianyu Weng

given: Jianyu

family: Zhu

full_name: Huanling Zhu

given: Huanling

family: Liu

full_name: Xiaoli Liu

given: Xiaoli

family: Hochhaus

full_name: Andreas Hochhaus

given: Andreas

family: Kim

full_name: Dong-Wook Kim

given: Dong-Wook

family: Radich

full_name: Jerald Radich

given: Jerald

family: Savona

full_name: Michael Savona

given: Michael

family: Martin-Regueira

full_name: Patricia Martin-Regueira

given: Patricia

family: Sy

full_name: Oumar Sy

given: Oumar

family: Gurnani

full_name: Renuka Gurnani

given: Renuka

family: Saglio

full_name: Giuseppe Saglio

given: Giuseppe

journal_name: Leukemia

repository_institution: INFN Catania - INFM-OAR

repository_normalized: Zenodo

repositories:
PubMed Central
Zenodo

lead_sponsor: Bristol-Myers Squibb

location_country:
Italy
Austria
Brazil
Spain
France
Czechia
Korea, Republic of
Poland
Thailand
Hungary
Argentina
Belgium
China
United States
Canada

location_facility: Kaiser Permanente Oncology Clinical Trials

location_facility: Institute of Oncology Hematology Biomedical Research

location_facility: Tennesssee Oncology - Centennial Clinic Location

location_facility: Northern Indiana Cancer Research Consortium

location_facility: Froedtert & Medical College of Wisconsin

location_facility: University Of Southern California University Hospital

location_facility: Kaiser Permanente Medical Center_Fontana

status_simplified: Ongoing


lead_sponsor: Pierre Fabre Medicament

location_country:
France
Hungary
Spain
Germany
Czech Republic

location_facility: Complejo Hospitalario de Pontevedra- Montecelo

location_facility: Pécsi Tudományegyetem Általános Orvostudományi Kar

location_facility: Universitätsklinikum Schleswig-Holstein Campus Lübeck

location_facility: Borsod Abaúj Zemplén Megyei Kórház és Egyetemi Oktató Kórház

location_facility: Debreceni Egyetem Orvos- és Egészségtudományi Centrum

title:
EFFECT OF V0251 IN ACUTE VERTIGO.
 A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.

summary: Assessment of efficacy and tolerance of a new anti-dizziness drug in acute vertigo.


ReferenceCitation: Gladman DD, Kavanaugh A, Gómez-Reino JJ, Wollenhaupt J, Cutolo M, Schett G, Lespessailles E, Guerette B, Delev N, Teng L, Edwards CJ, Birbara CA, Mease PJ. Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1-3 studies. RMD Open. 2018 Jun 27;4(1):e000669. doi: 10.1136/rmdopen-2018-000669. eCollection 2018.

family: Gladman

full_name: Dafna D Gladman

given: Dafna D

family: Kavanaugh

full_name: Arthur Kavanaugh

given: Arthur

family: Gómez-Reino

full_name: Juan J Gómez-Reino

given: Juan J

family: Wollenhaupt

full_name: Jürgen Wollenhaupt

given: Jürgen

family: Cutolo

full_name: Maurizio Cutolo

given: Maurizio

family: Schett

full_name: Georg Schett

given: Georg

family: Lespessailles

full_name: Eric Lespessailles

given: Eric

family: Guerette

full_name: Benoit Guerette

given: Benoit

family: Delev

full_name: Nikolay Delev

given: Nikolay

family: Teng

full_name: Lichen Teng

given: Lichen

family: Edwards

full_name: Christopher J Edwards

given: Christopher J

family: Birbara

full_name: Charles A Birbara

given: Charles A

family: Mease

full_name: Philip J Mease

given: Philip J

journal_name: RMD Open

repository_institution: American Medical Association - The Journal of the American Medical Association (JAMA) Network

title: Therapeutic benefit of apremilast on enthesitis and dactylitis in patients with psoriatic arthritis: a pooled analysis of the PALACE 1–3 studies

ReferenceCitation: Kavanaugh A, Gladman DD, Edwards CJ, Schett G, Guerette B, Delev N, Teng L, Paris M, Mease PJ. Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1-3 pooled analysis. Arthritis Res Ther. 2019 May 10;21(1):118. doi: 10.1186/s13075-019-1901-3.

full_name: Dafna D. Gladman

given: Dafna D.

full_name: Christopher J. Edwards

given: Christopher J.

repository_institution: Kooperativer Bibliotheksverbund Berlin-Brandenburg - OPUS Repository

title: Long-term experience with apremilast in patients with psoriatic arthritis: 5-year results from a PALACE 1–3 pooled analysis

ReferenceCitation: Taylor PC, van der Heijde D, Landewé R, McCue S, Cheng S, Boonen A. A Phase III Randomized Study of Apremilast, an Oral Phosphodiesterase 4 Inhibitor, for Active Ankylosing Spondylitis. J Rheumatol. 2021 Aug;48(8):1259-1267. doi: 10.3899/jrheum.201088. Epub 2021 Feb 15.

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:
Austria
United States
Sweden
Netherlands
Germany
France
Bulgaria
Czechia
Poland
Slovakia
Romania
Hungary
Australia
Russian Federation
Spain
Estonia
Canada
United Kingdom

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela Travesía de la Choupana s/n

location_facility: IPROS - CHR ORLEANS - Hôpital de la Source

location_facility: Clinic: University of Calgary Heritage Medical Research Clinic (HMRC),Teaching Research and Wellness (TRW)

location_facility: Centrum fur innovative Diagnostik und Therapie Rheumatologie Immunologie GmbH

location_facility: University of Utah Hospitals and Clinics

location_facility: Cividino Medicine Professional Corporation

location_facility: National Multiprofile Transport Hospital Tzar Boris III

location_facility: Veszprem Megyei Csolnoky Ferenc Korhaz-Rendelointezet

location_facility: Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: NZOZ NASZ LEKARZ Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna

location_facility: Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Federal State Budget Institution "Rheumatology Research Institute RAMS"

location_facility: NZOZ Osteo-Medic sc A. Racewicz J. Supronik

location_facility: Sf Apostol Andrei Emergency Clinical County Hospital

location_facility: Diagnostic and Consulting Center Sv. Pantaleymon

location_facility: Dr. William G. Bensen Medicine Professional Corporation

location_facility: MUDr. Zuzana Cizmarikova, s.r.o., Reumatologick ambulancia

location_facility: Departmental Hospital at Smolensk Station RZhD JSC

location_facility: Royal National Hospital for Rheumatic Diseases

location_facility: The Arthritis Program Research Group Inc.

location_facility: Cristei R. Rodica - Private Medical Practice

location_facility: Nizhniy Novgorod State Medical Academy of Roszdrav

location_facility: Fakultni Thomayerova nemocnice s poliklinikou - Klinicko-farmakologicka jednotka

location_facility: Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

title: A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF APREMILAST (CC-10004) IN THE TREATMENT OF ACTIVE ANKYLOSING SPONDYLITIS

summary: Apremilast is a new, orally available, small molecule drug that specifically inhibits phosphodiesterase 4 (PDE4), an enzyme that modulates inflammatory cytokines. This clinical study tests whether apremilast can improve the signs and symptoms of ankylosing spondylitis.