Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
NCT ID: NCT01894516
Last Updated: 2020-12-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
287 participants
INTERVENTIONAL
2013-10-08
2015-05-29
Brief Summary
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* During the course of the study, patients were also examined for any side effects that could occur (safety and tolerability), and the amount of GLPG0634 present in the blood (Pharmacokinetics) as well as the effects of GLPG0634 on disease- and mechanism of action-related parameters in the blood (Pharmacodynamics) were determined. Also, the effects of different doses of GLPG0634 administration on participants' disability, fatigue and quality of life were evaluated.
Detailed Description
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* However, at Week 12, all participants on placebo and the participants on the 50 mg dose who had not achieved 20% improvement in swollen joint count (SJC66) and tender joint count (TJC68) were assigned (automatically via interactive web response system (IWRS)) to 100 mg once daily (QD) in a blinded fashion and continued treatment until Week 24.
* Participants in the other groups maintained their randomized treatment until Week 24.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD during Weeks 13 to 24.
Placebo
Placebo capsules.
GLPG0634 50 mg QD
Participants received GLPG0634 50 mg capsules, orally, QD during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 50 mg QD while nonresponders were re-randomized to 100 mg QD during Weeks 13 to 24.
GLPG0634
GLPG0634 capsules.
GLPG0634 100 mg QD
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
GLPG0634
GLPG0634 capsules.
GLPG0634 200 mg QD
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
GLPG0634
GLPG0634 capsules.
Interventions
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GLPG0634
GLPG0634 capsules.
Placebo
Placebo capsules.
Eligibility Criteria
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Inclusion Criteria
* have a diagnosis of RA since at least 6 months and meeting the 2010 ACR/EULAR criteria of RA and ACR functional class I-III,
* have ≥6 swollen joints (from a 66-joint count) and
≥8 tender joints (from a 68-joint count) at Screening and at Baseline,
* Screening serum c-reactive protein ≥ 0.7 x upper limit of laboratory normal range (ULN),
* have shown an inadequate response in terms of either lack of efficacy or toxicity to MTX,
* have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.
Exclusion Criteria
* current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; where the biologic DMARD was effective, and if discontinued, this should not be due to lack of efficacy,
* previous treatment at any time with a cytotoxic agent, other than MTX, before Screening.
18 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Responsible Party
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Principal Investigators
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Galapagos Study Director
Role: STUDY_DIRECTOR
Galapagos NV
Locations
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Artho Care, Arthritis Care & Research P.C.
Gilbert, Arizona, United States
Arizona Arthritis & Rheumatology Research PLLC
Mesa, Arizona, United States
Arizona Arthritis Rheum Res
Phoenix, Arizona, United States
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States
C.V. Mehta MD Medical Corp.
Hemet, California, United States
Center for Innovative Therapy Division of Rheumatology, UCSD
La Jolla, California, United States
Desert Medical Advances
Palm Desert, California, United States
Infosphere Clinical Research, Inc.
West Hills, California, United States
Lovelace Scientific Resources
Venice, Florida, United States
Arthritis Center of North GA
Gainesville, Georgia, United States
The Arthritis Center
Springfield, Illinois, United States
Klein and Associates MD
Hagerstown, Maryland, United States
Private practice
Lansing, Michigan, United States
Arthritis Center of Reno
Reno, Nevada, United States
New Jersey Physicians, LLC
Clifton, New Jersey, United States
Health research of Oklahoma
Oklahoma City, Oklahoma, United States
Altoona Center Clin Research
Duncansville, Pennsylvania, United States
Low Country Rheumatology, PA
Charleston, South Carolina, United States
Arthritis Clinic
Jackson, Tennessee, United States
Austin Rheumatology Research PA
Austin, Texas, United States
Pioneer Research Solutions Inc
Houston, Texas, United States
Centro de Investigaciones Medicas Lanus
Lanús, , Argentina
Instituto Centralizado de Asistencia e investigacion Clinica Integral
Rosario, , Argentina
Centro Médico Privado de Reumatología
San Miguel de Tucumán, , Argentina
Royal Prince Alfred Hospital
Camperdown, , Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Rheumazentrum Favoriten
Vienna, , Austria
"Multiprofile Hospital for Active Treatment - Kaspela" LTD
Plovdiv, , Bulgaria
Clinic of Rheumatology MHAT
Sofia, , Bulgaria
Hospital Regional "Guillermo Grant Benavente"
Concepción, , Chile
Private Office
Temuco, , Chile
Fundación del Caribe para la Investigación Biomédica BIOS
Barranquilla, , Colombia
Centro Integral de Reumatologia SAS
Bogotá, , Colombia
Cirei Sas
Bogotá, , Colombia
Idearg S.A.S.
Bogotá, , Colombia
Medicity S.A.S.
Bucaramanga, , Colombia
Preventive Care Ltda
Chía, , Colombia
Schlossparkklinik - Akad. Lehrkrankenhaus Charite
Berlin, , Germany
Schwerpunktpraxis fuer Rheumatologie
Hamburg, , Germany
Clinica Médica Especializada en Medicina Interna
Guatemala City, , Guatemala
Reuma S.A.
Guatemala City, , Guatemala
Reuma-Centro
Guatemala City, , Guatemala
DRC
Balatonfüred, , Hungary
Qualiclinic Ltd
Budapest, , Hungary
Revita Clinic
Budapest, , Hungary
Csolnoky Ferenc County Hospital
Veszprém, , Hungary
L. Atikes doktorats
Liepāja, , Latvia
"Bruninieku" Polyclinic
Riga, , Latvia
Arké Estudios Clínicos S.A. de C.V.
México, , Mexico
Centro Medico Dalinde
México, , Mexico
Clinstile, S.A. de C.V.
México, , Mexico
Mexico Centre for Clinical Research
México, , Mexico
Hospital Universitario
Monterrey, , Mexico
Hospital de Especialidades
Oaxaca City, , Mexico
IMSP Institutul de Cardiologie
Chisinau, , Moldova
North Shore hospital
Auckland, , New Zealand
Timaru Rheumatology Studies
Timaru, , New Zealand
Silesiana Centrum Medyczne
Bytom, , Poland
Centrum Kliniczno
Elblag, , Poland
Medica Pro Familia Sp. z o.o. S.K.A.
Katowice, , Poland
Nowomed
Krakow, , Poland
Nzoz "Dobry Lekarz"
Krakow, , Poland
NZOZ Przychodnia Lekarska "Eskulap"
Skierniewice, , Poland
NZOZ Medicus Bonus
Środa Wielkopolska, , Poland
AMED Medical Center
Warsaw, , Poland
Ars Rheumatica Sp. Z.o.o.
Warsaw, , Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu
Wroclaw, , Poland
Ianuli Med Consult SRL
Bucharest, , Romania
Sana Medical Center
Bucharest, , Romania
Spitalul Clinic Sfanta Maria
Bucharest, , Romania
Emergency County Hospital
Galati, , Romania
Orenburg State Medical Academy
Orenburg, , Russia
GUZ "Regional Clinical Hospital"
Saratov, , Russia
Vladimir Reg Clin Hosp
Vladimir, , Russia
Hospital General Elche
Elche, , Spain
Consorci Sanitari Parc Tauli
Sabadell, , Spain
CICEC S.L.P Hospital Ntra.Sra.de la Esperanza
Santiago de Compostela, , Spain
V. Gusak Institute of Urgent and Recovery Surgery
Donetsk, , Ukraine
City Hospital #8
Kharkiv, , Ukraine
Municipal Hospital
Kherson, , Ukraine
Central Outpatient Hospital of Deanyanskyy Distric
Kiev, , Ukraine
Regional Clinical Hospital
Vinnytsia, , Ukraine
Countries
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References
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Balsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.
Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.
Tarrant JM, Galien R, Li W, Goyal L, Pan Y, Hawtin R, Zhang W, Van der Aa A, Taylor PC. Filgotinib, a JAK1 Inhibitor, Modulates Disease-Related Biomarkers in Rheumatoid Arthritis: Results from Two Randomized, Controlled Phase 2b Trials. Rheumatol Ther. 2020 Mar;7(1):173-190. doi: 10.1007/s40744-019-00192-5. Epub 2020 Jan 7.
Kavanaugh A, Kremer J, Ponce L, Cseuz R, Reshetko OV, Stanislavchuk M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: results from a randomised, dose-finding study (DARWIN 2). Ann Rheum Dis. 2017 Jun;76(6):1009-1019. doi: 10.1136/annrheumdis-2016-210105. Epub 2016 Dec 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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GLPG0634-CL-204 (DARWIN2)
Identifier Type: -
Identifier Source: org_study_id