Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants

Last updated: May 6, 2024
Sponsor: Galapagos NV
Overall Status: Completed

Phase

2

Condition

Joint Injuries

Rheumatoid Arthritis

Dermatomyositis (Connective Tissue Disease)

Treatment

Filgotinib

Clinical Study ID

NCT02065700
GLPG0634-CL-205
2012-003655-11
  • Ages > 18
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  • Participants who completed one of the qualifying core studies GLPG0634-CL-203 orGLPG0634-CL-204 and may benefit from filgotinib long-term treatment according to theInvestigator's judgment

  • Females of childbearing potential and sexually active men must agree to use highlyeffective method of birth control as specified in the protocol, during the study andfor at least 12 weeks after the last dose of filgotinib

Exclusion

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 orGLPG0634-CL-204), according to the Investigator's judgment

  • Diagnosis of rheumatic autoimmune disease or inflammatory joint disease other thanrheumatoid arthritis, except for secondary Sjogren's syndrome

  • Any condition or circumstances which, in the opinion of the Investigator, may make aparticipant unlikely or unable to complete the study or comply with study proceduresand requirements

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

Study Design

Total Participants: 739
Treatment Group(s): 1
Primary Treatment: Filgotinib
Phase: 2
Study Start date:
February 25, 2014
Estimated Completion Date:
January 19, 2023

Connect with a study center

  • Atencion Integral en Reumatologa

    Buenos Aires,
    Argentina

    Site Not Available

  • CER Intituto Medico

    Buenos Aires,
    Argentina

    Site Not Available

  • Organizacion Medica de Investigaciones (OMI)

    Buenos Aires,
    Argentina

    Site Not Available

  • Instituto Reumatologico Strusberg

    Cordoba,
    Argentina

    Site Not Available

  • CIMeL Centro dee Investigacion Medico Lanus

    Lanus,
    Argentina

    Site Not Available

  • Instituto Medico CER

    Quilmes,
    Argentina

    Site Not Available

  • Instituto CAICI

    Rosario,
    Argentina

    Site Not Available

  • Instituto de Asistencia Reumatologia Integral - IARI

    San Fernando,
    Argentina

    Site Not Available

  • Centro Médico Privado de Reumatologia

    San Miguel de Tucumán,
    Argentina

    Site Not Available

  • Centro Médico Privado de Reumatologia

    Tucuman,
    Argentina

    Site Not Available

  • Flinders Medical Centre

    Bedford Park, Flinders Drive, South Australia
    Australia

    Site Not Available

  • Monash Medical Centre

    Clayton, Victoria
    Australia

    Site Not Available

  • Repatriation General Hospital

    Daw Park,
    Australia

    Site Not Available

  • Princess Alexandra Hospital

    Woolloongabba,
    Australia

    Site Not Available

  • Cliniques Universitaires St-Luc

    Brussels,
    Belgium

    Site Not Available

  • AZ Groeninge

    Kortrijk,
    Belgium

    Site Not Available

  • UZ Leuven

    Leuven,
    Belgium

    Site Not Available

  • "Multiprofile Hospital for Active Treatment - Kaspela" LTD

    Plovdiv,
    Bulgaria

    Site Not Available

  • University "Multiprofile Hospital for Active Treatment - Kaspela" LTD

    Plovdiv,
    Bulgaria

    Site Not Available

  • MHAT Ruse AD

    Rusa,
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment - Ruse

    Ruse,
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center "Sveta Anna" LTD

    Sofia,
    Bulgaria

    Site Not Available

  • National Multiprofile Transport Hospital "Tsar Boris III," Sofia, Clinical of Internal Diseases

    Sofia,
    Bulgaria

    Site Not Available

  • University Multiprofile Hospital for Active Treatment "SV. Ivan Rilski" EAD, Sofia, Rheumatology Clinic

    Sofia,
    Bulgaria

    Site Not Available

  • Hospital Regional "Guillermo Grant Benavente"

    Concepcion,
    Chile

    Site Not Available

  • Hospital Regional "Guillermo Grant Benavente"

    Santiago,
    Chile

    Site Not Available

  • Prosalud

    Santiago,
    Chile

    Site Not Available

  • Someal SA

    Santiago,
    Chile

    Site Not Available

  • Centro de Investigacion Clinica del Sur

    Temuco,
    Chile

    Site Not Available

  • Consulta Privada Dra. Ponce

    Temuco,
    Chile

    Site Not Available

  • Medicity S.A.S.

    Bucaramanga, Santander
    Colombia

    Site Not Available

  • Circaribe S.A.S

    Barranquilla,
    Colombia

    Site Not Available

  • Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)

    Bogota, 110221
    Colombia

    Site Not Available

  • Idearg Sas

    Bogota,
    Colombia

    Site Not Available

  • Riesgo De Fractura Cayre Ips7

    Bogotá, 110221
    Colombia

    Site Not Available

  • Preventive Care SAS

    Cundinamarca,
    Colombia

    Site Not Available

  • Hospital Pablo Tobon Uribe

    Medellin,
    Colombia

    Site Not Available

  • Revmatologie S.R.O

    Brno,
    Czechia

    Site Not Available

  • Revmatologicka a interni ambulance

    Kladno,
    Czechia

    Site Not Available

  • Revmatologicka ambulance

    Praha-Nusle,
    Czechia

    Site Not Available

  • PV-Medical S.R.O.

    Zlin,
    Czechia

    Site Not Available

  • Hospitaux universitaires de Strasbourg

    Strasbourg,
    France

    Site Not Available

  • Hospitaux de Hautepierre

    Strasbourg CEDEX,
    France

    Site Not Available

  • Schlossparkklinik - Akad. Lehrkrankenhaus Charite

    Berlin,
    Germany

    Site Not Available

  • MVZ Rheumatologie and Autoimmun Medizin HH GmbH

    Hamburg,
    Germany

    Site Not Available

  • Clinica Medica

    Guatemala,
    Guatemala

    Site Not Available

  • Clinica Medica Especializada en Reumatologia

    Guatemala,
    Guatemala

    Site Not Available

  • Clinica de Especialidades Medicas

    Guatemala,
    Guatemala

    Site Not Available

  • Reuma S.A.

    Guatemala,
    Guatemala

    Site Not Available

  • Reuma-Centro

    Guatemala,
    Guatemala

    Site Not Available

  • Centro Clinico

    Guatemala City,
    Guatemala

    Site Not Available

  • Gyogyszervizs galo Kozpont Kft

    Balatonfured,
    Hungary

    Site Not Available

  • QualiClinic Kft.

    Budapest,
    Hungary

    Site Not Available

  • Reumatologiai Kft.

    Budapest,
    Hungary

    Site Not Available

  • Markhot Ferenc Hospital, Rheumatology

    Eger,
    Hungary

    Site Not Available

  • Csolnoky Ferenc Hospital, Rheumatology

    Veszprem,
    Hungary

    Site Not Available

  • Carmel Medical Center

    Haifa,
    Israel

    Site Not Available

  • Rambam Medical Center

    Haifa,
    Israel

    Site Not Available

  • Ltd M&M Centr

    Adazi,
    Latvia

    Site Not Available

  • SIA Arijas Ancane's Family Doctor

    Baldone,
    Latvia

    Site Not Available

  • Daugavpils Regional Hospital

    Daugavpils,
    Latvia

    Site Not Available

  • Meda D

    Daugavplis,
    Latvia

    Site Not Available

  • L. Atikes doktorats

    Liepaja,
    Latvia

    Site Not Available

  • 'Bruninieku' polyclinic

    Riga,
    Latvia

    Site Not Available

  • Centro Medico Dalinde

    Ciudad de Mexico,
    Mexico

    Site Not Available

  • Centro Medico Dalinde

    Ciudad de México,
    Mexico

    Site Not Available

  • Centro de Estudios de Investigacion Basica y Clinica, SC

    Guadalajara,
    Mexico

    Site Not Available

  • Arke Estudios Clinicos S.A. de C.V.

    Mexico,
    Mexico

    Site Not Available

  • Clinstile, S.A. de C.V.

    Mexico,
    Mexico

    Site Not Available

  • Hospital General de México

    Mexico,
    Mexico

    Site Not Available

  • Hospital Universitario José E. Gonzalez

    Monterrey,
    Mexico

    Site Not Available

  • OSMO

    Oaxaca,
    Mexico

    Site Not Available

  • IMSP Institutul de Cardiologie

    Chisinau,
    Moldova, Republic of

    Site Not Available

  • Waikato Hospital

    Hamilton,
    New Zealand

    Site Not Available

  • Timaru Rheumatology Studies

    Timaru,
    New Zealand

    Site Not Available

  • NZOZ Osteo-Medic s.c.

    Bialystok,
    Poland

    Site Not Available

  • Centrum Medyczne Silesian a Sp. Z.o.o.

    Bytom,
    Poland

    Site Not Available

  • Centrum Medyczne Silesiana Sp. Z.o.o.

    Bytom,
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice

    Katowice,
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Katowice la

    Katowice,
    Poland

    Site Not Available

  • Centrum Medyczne Plejady

    Krakow,
    Poland

    Site Not Available

  • NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie

    Krakow,
    Poland

    Site Not Available

  • Specjalisty Czne Centrum Medyczne Nowomed

    Krakow,
    Poland

    Site Not Available

  • Specjalistyczne Centrum Medyczne Nowomed

    Krakow,
    Poland

    Site Not Available

  • NZOZ Przychodnia Lekarska "Eskulap"

    Skierniewice,
    Poland

    Site Not Available

  • Powiatowy Zaklad Opieki Zdrowotnej w Starachowicach

    Starachowice,
    Poland

    Site Not Available

  • Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach

    Starachowice,
    Poland

    Site Not Available

  • NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz

    Torun,
    Poland

    Site Not Available

  • AMED Medical Center

    Warsaw,
    Poland

    Site Not Available

  • Ars Rheumatica Sp. Z.o.o.

    Warszawa,
    Poland

    Site Not Available

  • Rheumatica Sp. Z.o.o.

    Warszawa,
    Poland

    Site Not Available

  • Spitalul Clinic Sfanta Maria

    Bucuresti,
    Romania

    Site Not Available

  • Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati

    Galati,
    Romania

    Site Not Available

  • First Moscow State Medical University n.a. I.M. Sechenova of the Ministry of Health

    Moscow,
    Russian Federation

    Site Not Available

  • Scientific Research Institute of Rheumatology

    Moscow,
    Russian Federation

    Site Not Available

  • City Clinical Hospital #5

    Nizhniy Novgorod,
    Russian Federation

    Site Not Available

  • GBOU VPO Orenburg State Medical University

    Orenburg,
    Russian Federation

    Site Not Available

  • Ryazan State Medical University

    Ryazan,
    Russian Federation

    Site Not Available

  • Regional Clinical Hospital

    Saratov,
    Russian Federation

    Site Not Available

  • City Hospital #26

    St Petersburg,
    Russian Federation

    Site Not Available

  • Vladimir Regional State Instituion of Healthcare

    Vladimir,
    Russian Federation

    Site Not Available

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña,
    Spain

    Site Not Available

  • Sanatorio Nuestra Señora de la Esperanza

    A Coruña,
    Spain

    Site Not Available

  • Complejo Hospitalario Universitario

    Coruña,
    Spain

    Site Not Available

  • Hospital Parc Tauli

    Sabadell,
    Spain

    Site Not Available

  • CICEC S.L.P Hospital Ntra.Sra.de la Esperanza

    Santiago de Compostella,
    Spain

    Site Not Available

  • Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13

    Kharkiv,
    Ukraine

    Site Not Available

  • Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology

    Kharkiv,
    Ukraine

    Site Not Available

  • L.T. Malaya Therapy Institute of National Academy of Medical Sciences of Ukraine

    Kharkiv,
    Ukraine

    Site Not Available

  • Kherson City Clinical Hospital N. A. Afanasii and Olga Tropin

    Kherson,
    Ukraine

    Site Not Available

  • Municipal Non-Profit Institution Consultative and Diagnostic Centre of Desnyasky District of Kyiv

    Kiev,
    Ukraine

    Site Not Available

  • Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kiev city

    Kyiv,
    Ukraine

    Site Not Available

  • Vinnitsya Regional Clinical Hospital Named after M.I.Pirogov, Rheumatology Department

    Vinnytsya,
    Ukraine

    Site Not Available

  • Arthro, Arthritis Care & Research

    Gilbert, Arizona
    United States

    Site Not Available

  • Arizona Arthritis & Rheumatology Research PLLC

    Mesa, Arizona
    United States

    Site Not Available

  • C.V. Mehta MD Medical Corp.

    Hemet, California
    United States

    Site Not Available

  • Desert Medical Advances

    Palm Desert, California
    United States

    Site Not Available

  • RASF Clinical Research Center

    Boca Raton, Florida
    United States

    Site Not Available

  • Millenium Research

    Ormond Beach, Florida
    United States

    Site Not Available

  • Lovelace Scientific Resources

    Venice, Florida
    United States

    Site Not Available

  • Springfield Clinic

    Springfield, Illinois
    United States

    Site Not Available

  • Klein and Associates MD, PA

    Hagerstown, Maryland
    United States

    Site Not Available

  • Physicians East

    Greenville, North Carolina
    United States

    Site Not Available

  • Health Research of Oklahoma

    Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Low County Rheumatology PA

    Charleston, South Carolina
    United States

    Site Not Available

  • West Tennessee Research Institute

    Jackson, Tennessee
    United States

    Site Not Available

  • Austin Rheumatology Research PA

    Austin, Texas
    United States

    Site Not Available

  • Pioneer Research Solutions Inc

    Houston, Texas
    United States

    Site Not Available

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