Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
NCT ID: NCT02065700
Last Updated: 2024-06-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
739 participants
INTERVENTIONAL
2014-02-25
2023-01-19
Brief Summary
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Participants were enrolled in this open-label long-term follow-up study after they had completed one of the two core studies, GLPG0634-CL-203 (DARWIN1) (NCT01888874) or GLPG0634-CL-204 (DARWIN2) (NCT01894516), and were evaluated for any side effects that might have occured (long-term safety and tolerability) when taking filgotinib. During the course of the study, participants were also examined for long-term effects of filgotinib administration on disease activity (efficacy), participant's disability, fatigue, and quality of life.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Filgotinib Darwin 1
Participants in Study GLPG0634-CL-203 (NCT01888874) were rolled-over to receive an oral dose of filgotinib at a daily dose of 200 milligrams (mg) in this extension study, with the exception of male participants in the United States (US) who were limited to a daily dose of 100 mg due to a Food and Drug Administration (FDA) requirement based on a non-clinical finding. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
In case of intolerance or for safety reasons, and as per investigator's discretion, a daily dose of filgotinib 200 mg could be decreased to 100 mg per day, and later returned to 200 mg per day after the reasons for decreasing the dose were resolved.
Filgotinib
Administered as Oral Tablets
Filgotinib Darwin 2
Participants from Study GLPG0634-CL-204 (NCT01894516) were rolled-over to receive oral dose of filgotinib tablet at 200 mg once daily (q.d) in this extension study. Treatment was administered until marketing, local (if applicable) regulatory and/or pertinent local reimbursement approval.
Participants started the study with the same dose level (filgotinib 200 mg per day) and in case of intolerance or safety reasons and as per investigator's discretion, the daily dose of filgotinib was decreased to 100 mg q.d and was returned to 200 mg per day after the reasons for decreasing the dose had resolved and at the investigator's discretion.
Filgotinib
Administered as Oral Tablets
Interventions
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Filgotinib
Administered as Oral Tablets
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Females of childbearing potential and sexually active men must agree to use highly effective method of birth control as specified in the protocol, during the study and for at least 12 weeks after the last dose of filgotinib
Exclusion Criteria
* Persistent abnormal lab values during one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), according to the Investigator's judgment
* Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis, except for secondary Sjogren's syndrome
* Any condition or circumstances which, in the opinion of the Investigator, may make a participant unlikely or unable to complete the study or comply with study procedures and requirements
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
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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Arthro, Arthritis Care & Research
Gilbert, Arizona, United States
Arizona Arthritis & Rheumatology Research PLLC
Mesa, Arizona, United States
C.V. Mehta MD Medical Corp.
Hemet, California, United States
Desert Medical Advances
Palm Desert, California, United States
RASF Clinical Research Center
Boca Raton, Florida, United States
Millenium Research
Ormond Beach, Florida, United States
Lovelace Scientific Resources
Venice, Florida, United States
Springfield Clinic
Springfield, Illinois, United States
Klein and Associates MD, PA
Hagerstown, Maryland, United States
Physicians East
Greenville, North Carolina, United States
Health Research of Oklahoma
Oklahoma City, Oklahoma, United States
Low County Rheumatology PA
Charleston, South Carolina, United States
West Tennessee Research Institute
Jackson, Tennessee, United States
Austin Rheumatology Research PA
Austin, Texas, United States
Pioneer Research Solutions Inc
Houston, Texas, United States
Atencion Integral en Reumatologa
Buenos Aires, , Argentina
CER Intituto Medico
Buenos Aires, , Argentina
Organizacion Medica de Investigaciones (OMI)
Buenos Aires, , Argentina
Instituto Reumatologico Strusberg
Córdoba, , Argentina
CIMeL Centro dee Investigacion Medico Lanus
Lanús, , Argentina
Instituto CAICI
Rosario, , Argentina
Instituto de Asistencia Reumatologia Integral - IARI
San Fernando, , Argentina
Centro Médico Privado de Reumatologia
San Miguel de Tucumán, , Argentina
Flinders Medical Centre
Bedford Park, Flinders Drive, South Australia, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Princess Alexandra Hospital
Woolloongabba, , Australia
Cliniques Universitaires St-Luc
Brussels, , Belgium
UZ Leuven
Leuven, , Belgium
University "Multiprofile Hospital for Active Treatment - Kaspela" LTD
Plovdiv, , Bulgaria
Multiprofile Hospital for Active Treatment - Ruse
Rousse, , Bulgaria
Diagnostic Consultative Center "Sveta Anna" LTD
Sofia, , Bulgaria
National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases
Sofia, , Bulgaria
University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic
Sofia, , Bulgaria
Hospital Regional "Guillermo Grant Benavente"
Santiago, , Chile
Prosalud
Santiago, , Chile
Someal SA
Santiago, , Chile
Centro de Investigacion Clinica del Sur
Temuco, , Chile
Consulta Privada Dra. Ponce
Temuco, , Chile
Medicity S.A.S.
Bucaramanga, Santander Department, Colombia
Circaribe S.A.S
Barranquilla, , Colombia
Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
Bogotá, , Colombia
Riesgo De Fractura Cayre Ips7
Bogotá, , Colombia
Idearg Sas
Bogotá, , Colombia
Preventive Care SAS
Cundinamarca, , Colombia
Hospital Pablo Tobon Uribe
Medellín, , Colombia
Revmatologie S.R.O
Brno, , Czechia
Revmatologicka a interni ambulance
Kladno, , Czechia
Revmatologicka ambulance
Praha-Nusle, , Czechia
PV-Medical S.R.O.
Zlín, , Czechia
Hospitaux de Hautepierre
Strasbourg, , France
Schlossparkklinik - Akad. Lehrkrankenhaus Charite
Berlin, , Germany
MVZ Rheumatologie and Autoimmun Medizin HH GmbH
Hamburg, , Germany
Centro Clinico
Guatemala City, , Guatemala
Clinica de Especialidades Medicas
Guatemala City, , Guatemala
Clinica Medica Especializada en Reumatologia
Guatemala City, , Guatemala
Clinica Medica
Guatemala City, , Guatemala
Reuma S.A.
Guatemala City, , Guatemala
Reuma-Centro
Guatemala City, , Guatemala
Gyogyszervizs galo Kozpont Kft
Balatonfüred, , Hungary
QualiClinic Kft.
Budapest, , Hungary
Reumatologiai Kft.
Budapest, , Hungary
Markhot Ferenc Hospital, Rheumatology
Eger, , Hungary
Csolnoky Ferenc Hospital, Rheumatology
Veszprém, , Hungary
Carmel Medical Center
Haifa, , Israel
Rambam Medical Center
Haifa, , Israel
Ltd M&M Centr
Ādaži, , Latvia
SIA Arijas Ancane's Family Doctor
Baldone, , Latvia
Daugavpils Regional Hospital
Daugavpils, , Latvia
L. Atikes doktorats
Liepāja, , Latvia
'Bruninieku' polyclinic
Riga, , Latvia
Centro de Estudios de Investigacion Basica y Clinica, SC
Guadalajara, , Mexico
Centro Medico Dalinde
Mexico City, , Mexico
Arke Estudios Clinicos S.A. de C.V.
México, , Mexico
Clinstile, S.A. de C.V.
México, , Mexico
Hospital General de México
México, , Mexico
Hospital Universitario José E. Gonzalez
Monterrey, , Mexico
OSMO
Oaxaca City, , Mexico
IMSP Institutul de Cardiologie
Chisinau, , Moldova
Waikato Hospital
Hamilton, , New Zealand
Timaru Rheumatology Studies
Timaru, , New Zealand
NZOZ Osteo-Medic s.c.
Bialystok, , Poland
Centrum Medyczne Silesiana Sp. Z.o.o.
Bytom, , Poland
Centrum Medyczne Pratia Katowice
Katowice, , Poland
Centrum Medyczne Plejady
Krakow, , Poland
NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
Krakow, , Poland
Specjalistyczne Centrum Medyczne Nowomed
Krakow, , Poland
NZOZ Przychodnia Lekarska "Eskulap"
Skierniewice, , Poland
Powiatowy Zaklad Opieki Zdrowotnej w Starachowicach
Starachowice, , Poland
NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz
Torun, , Poland
AMED Medical Center
Warsaw, , Poland
Rheumatica Sp. Z.o.o.
Warsaw, , Poland
Spitalul Clinic Sfanta Maria
Bucharest, , Romania
Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati
Galati, , Romania
First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health
Moscow, , Russia
Scientific Research Institute of Rheumatology
Moscow, , Russia
City Clinical Hospital #5
Nizhny Novgorod, , Russia
GBOU VPO Orenburg State Medical University
Orenburg, , Russia
Ryazan State Medical University
Ryazan, , Russia
City Hospital #26
Saint Petersburg, , Russia
Regional Clinical Hospital
Saratov, , Russia
Vladimir Regional State Instituion of Healthcare
Vladimir, , Russia
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, , Spain
Sanatorio Nuestra Señora de la Esperanza
A Coruña, , Spain
Hospital Parc Tauli
Sabadell, , Spain
Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13
Kharkiv, , Ukraine
Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology
Kharkiv, , Ukraine
L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine
Kharkiv, , Ukraine
Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin
Kherson, , Ukraine
Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv
Kiev, , Ukraine
Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city
Kyiv, , Ukraine
Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department
Vinnytsia, , Ukraine
Countries
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References
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Genovese MC, Kavanaugh A, Winthrop K, et al. Long Term Safety of Filgotinib in the Treatment of Rheumatoid Arthritis: Week 84 Data from a Phase 2b Open-Label Extension Study [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10).
Kavanaugh A, Westhovens R, Winthrop K, et al. Rheumatoid Arthritis Treatment with Filgotinib: Week 156 Safety and Efficacy Data from a Phase 2b Open-Label Extension Study [abstract]. Arthritis Rheumatol. 2019; 71 (suppl 10).
R. Westhovens, R. Alten, K. Winthrop, et al. Long term safety of filgotinib in the treatment of rheumatoid arthritis: week 108 data from a phase 2b open-label extension study. [abstract]. Ann Rheum Dis. 2018;77 (suppl 2)
Kavanaugh A, Genovese MC, Winthrop K, et al. Rheumatoid Arthritis Treatment with Filgotinib: Week 132 Safety Data from a Phase 2b Open-Label Extension Study [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9).
Kavanaugh A, Westhovens RR, Winthrop KL, Lee SJ, Tan Y, An D, Ye L, Sundy JS, Besuyen R, Meuleners L, Stanislavchuk M, Spindler AJ, Greenwald M, Alten R, Genovese MC. Safety and Efficacy of Filgotinib: Up to 4-year Results From an Open-label Extension Study of Phase II Rheumatoid Arthritis Programs. J Rheumatol. 2021 Aug;48(8):1230-1238. doi: 10.3899/jrheum.201183. Epub 2021 Feb 1.
Westhovens R, Winthrop KL, Kavanaugh A, Greenwald M, Dagna L, Cseuz R, Besuyen R, de Vries D, Modgill V, Le LH, Genovese MC, Emery P, Verschueren P, Alten R. Safety and efficacy of filgotinib in patients with rheumatoid arthritis: final results of the DARWIN 3 long-term extension study. RMD Open. 2025 Jan 30;11(1):e004857. doi: 10.1136/rmdopen-2024-004857.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-003655-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GLPG0634-CL-205
Identifier Type: -
Identifier Source: org_study_id
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