Clinical trial NCT02065700: Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
Official title: A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Methotrexate
insufficient responders
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
Collaborators: name: Gilead Sciences
First posted: 2014-02-19
Enrollment: 739
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study was to evaluate the long-term safety and tolerability of filgotinib (formerly GLPG0634) for the treatment of rheumatoid arthritis.

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.


Eligibility criteria: Key Inclusion Criteria:

* Participants who completed one of the qualifying core studies GLPG0634-CL-203 or GLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to the Investigator's judgment
* 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

Key Exclusion Criteria:

* Participants who prematurely withdrew from one of the 2 core studies (GLPG0634-CL-203 or GLPG0634-CL-204), for any reason
* 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

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: From First dose to Week 437
Secondary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving ACR20 Response: Observed Case (OC)
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving ACR50 Response: NRI
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving ACR50 Response: OC
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving ACR70 Response: NRI
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving ACR70 Response: OC
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: ACR N% Improvement (ACR-N) Response: OC
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Change From Core Baseline in Disease Activity Score Based on 28 Joints Using C-reactive Protein (DAS28[CRP]): OC
timeFrame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Change From Core Baseline in Simple Disease Activity Index (SDAI): OC
timeFrame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Change From Core Baseline in Clinical Disease Activity Index (CDAI): OC
timeFrame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving European League Against Rheumatism (EULAR) Response: OC
timeFrame: Core Baseline, Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving ACR/EULAR Remission: NRI
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Percentage of Participants Achieving ACR/EULAR Remission: OC
timeFrame: Extension Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408
measure: Change From Core Baseline in Physical Component Score (PCS) of Quality of Life Using the Short Form-36 (SF-36) Scores: OC
timeFrame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
measure: Change From Core Baseline in MCS of Quality of Life Using the SF-36 Scores: OC
timeFrame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
measure: Change From Core Baseline in Quality of Life Using Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale: OC
timeFrame: Core Baseline, Extension Baseline, Weeks 48, 96, 144, 192, 240, 288, 336, 384
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Arthro, Arthritis Care & Research
state: Arizona
city: Mesa
country: United States
facility: Arizona Arthritis & Rheumatology Research PLLC
state: Arizona
city: Hemet
country: United States
facility: C.V. Mehta MD Medical Corp.
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Boca Raton
country: United States
facility: RASF Clinical Research Center
state: Florida
city: Ormond Beach
country: United States
facility: Millenium Research
state: Florida
city: Venice
country: United States
facility: Lovelace Scientific Resources
state: Florida
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: Hagerstown
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Greenville
country: United States
facility: Physicians East
state: North Carolina
city: Oklahoma City
country: United States
facility: Health Research of Oklahoma
state: Oklahoma
city: Charleston
country: United States
facility: Low County Rheumatology PA
state: South Carolina
city: Jackson
country: United States
facility: West Tennessee Research Institute
state: Tennessee
city: Austin
country: United States
facility: Austin Rheumatology Research PA
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc
state: Texas
city: Buenos Aires
country: Argentina
facility: Atencion Integral en Reumatologa
city: Buenos Aires
country: Argentina
facility: CER Intituto Medico
city: Buenos Aires
country: Argentina
facility: Organizacion Medica de Investigaciones (OMI)
city: Cordoba
country: Argentina
facility: Instituto Reumatologico Strusberg
city: Lanus
country: Argentina
facility: CIMeL Centro dee Investigacion Medico Lanus
city: Rosario
country: Argentina
facility: Instituto CAICI
city: San Fernando
country: Argentina
facility: Instituto de Asistencia Reumatologia Integral - IARI
city: San Miguel de Tucumán
country: Argentina
facility: Centro Médico Privado de Reumatologia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
state: Flinders Drive, South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
city: Brussels
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Leuven
country: Belgium
facility: UZ Leuven
city: Plovdiv
country: Bulgaria
facility: University "Multiprofile Hospital for Active Treatment - Kaspela" LTD
city: Ruse
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment - Ruse
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center "Sveta Anna" LTD
city: Sofia
country: Bulgaria
facility: National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic
city: Santiago
country: Chile
facility: Hospital Regional "Guillermo Grant Benavente"
city: Santiago
country: Chile
facility: Prosalud
city: Santiago
country: Chile
facility: Someal SA
city: Temuco
country: Chile
facility: Centro de Investigacion Clinica del Sur
city: Temuco
country: Chile
facility: Consulta Privada Dra. Ponce
city: Bucaramanga
country: Colombia
facility: Medicity S.A.S.
state: Santander
city: Barranquilla
country: Colombia
facility: Circaribe S.A.S
city: Bogota
country: Colombia
facility: Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)
city: Bogota
country: Colombia
facility: Idearg Sas
city: Bogotá
country: Colombia
facility: Riesgo De Fractura Cayre Ips7
city: Cundinamarca
country: Colombia
facility: Preventive Care SAS
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
city: Brno
country: Czechia
facility: Revmatologie S.R.O
city: Kladno
country: Czechia
facility: Revmatologicka a interni ambulance
city: Praha-Nusle
country: Czechia
facility: Revmatologicka ambulance
city: Zlin
country: Czechia
facility: PV-Medical S.R.O.
city: Strasbourg CEDEX
country: France
facility: Hospitaux de Hautepierre
city: Berlin
country: Germany
facility: Schlossparkklinik - Akad. Lehrkrankenhaus Charite
city: Hamburg
country: Germany
facility: MVZ Rheumatologie and Autoimmun Medizin HH GmbH
city: Guatemala City
country: Guatemala
facility: Centro Clinico
city: Guatemala
country: Guatemala
facility: Clinica de Especialidades Medicas
city: Guatemala
country: Guatemala
facility: Clinica Medica Especializada en Reumatologia
city: Guatemala
country: Guatemala
facility: Clinica Medica
city: Guatemala
country: Guatemala
facility: Reuma S.A.
city: Guatemala
country: Guatemala
facility: Reuma-Centro
city: Balatonfured
country: Hungary
facility: Gyogyszervizs galo Kozpont Kft
city: Budapest
country: Hungary
facility: QualiClinic Kft.
city: Budapest
country: Hungary
facility: Reumatologiai Kft.
city: Eger
country: Hungary
facility: Markhot Ferenc Hospital, Rheumatology
city: Veszprem
country: Hungary
facility: Csolnoky Ferenc Hospital, Rheumatology
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Adazi
country: Latvia
facility: Ltd M&M Centr
city: Baldone
country: Latvia
facility: SIA Arijas Ancane's Family Doctor
city: Daugavpils
country: Latvia
facility: Daugavpils Regional Hospital
city: Liepaja
country: Latvia
facility: L. Atikes doktorats
city: Riga
country: Latvia
facility: 'Bruninieku' polyclinic
city: Ciudad de Mexico
country: Mexico
facility: Centro Medico Dalinde
city: Guadalajara
country: Mexico
facility: Centro de Estudios de Investigacion Basica y Clinica, SC
city: Mexico
country: Mexico
facility: Arke Estudios Clinicos S.A. de C.V.
city: Mexico
country: Mexico
facility: Clinstile, S.A. de C.V.
city: Mexico
country: Mexico
facility: Hospital General de México
city: Monterrey
country: Mexico
facility: Hospital Universitario José E. Gonzalez
city: Oaxaca
country: Mexico
facility: OSMO
city: Chisinau
country: Moldova, Republic of
facility: IMSP Institutul de Cardiologie
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Timaru
country: New Zealand
facility: Timaru Rheumatology Studies
city: Bialystok
country: Poland
facility: NZOZ Osteo-Medic s.c.
city: Bytom
country: Poland
facility: Centrum Medyczne Silesiana Sp. Z.o.o.
city: Katowice
country: Poland
facility: Centrum Medyczne Pratia Katowice
city: Krakow
country: Poland
facility: Centrum Medyczne Plejady
city: Krakow
country: Poland
facility: NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie
city: Krakow
country: Poland
facility: Specjalistyczne Centrum Medyczne Nowomed
city: Skierniewice
country: Poland
facility: NZOZ Przychodnia Lekarska "Eskulap"
city: Starachowice
country: Poland
facility: Powiatowy Zaklad Opieki Zdrowotnej w Starachowicach
city: Torun
country: Poland
facility: NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz
city: Warsaw
country: Poland
facility: AMED Medical Center
city: Warszawa
country: Poland
facility: Rheumatica Sp. Z.o.o.
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sfanta Maria
city: Galati
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Rheumatology
city: Nizhniy Novgorod
country: Russian Federation
facility: City Clinical Hospital #5
city: Orenburg
country: Russian Federation
facility: GBOU VPO Orenburg State Medical University
city: Ryazan
country: Russian Federation
facility: Ryazan State Medical University
city: Saratov
country: Russian Federation
facility: Regional Clinical Hospital
city: St Petersburg
country: Russian Federation
facility: City Hospital #26
city: Vladimir
country: Russian Federation
facility: Vladimir Regional State Instituion of Healthcare
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
city: A Coruña
country: Spain
facility: Sanatorio Nuestra Señora de la Esperanza
city: Sabadell
country: Spain
facility: Hospital Parc Tauli
city: Kharkiv
country: Ukraine
facility: Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13
city: Kharkiv
country: Ukraine
facility: Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology
city: Kharkiv
country: Ukraine
facility: L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine
city: Kherson
country: Ukraine
facility: Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin
city: Kiev
country: Ukraine
facility: Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city
city: Vinnytsya
country: Ukraine
facility: Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department
Study officials:
affiliation: Galapagos NV
name: Galapagos Study Director
role: STUDY_DIRECTOR
References:
citation: 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).
citation: 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).
citation: 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)
citation: 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).
citation: 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.
citation: 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.