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

NCT02065700 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: GLPG0634-CL-2052012-003655-11
• Study Type: interventional
• Target: 739
• Locations: 22 countries
• Sites: 111

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.

Conditions

Rheumatoid Arthritis

Keywords

Methotrexate; insufficient responders

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Treatment-Emergent Adverse Events

  An Adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. Treatment-emergent adverse events (TEAEs) were defined as any AEs with an onset date on or after the filgotinib start date in the core studies or GLPG0634-CL-205 (NCT02065700), and no later than 30 days after permanent discontinuation of filgotinib in GLPG0634-CL-205 (NCT02065700) or of either 30 days after the last dose date.

  From First dose to Week 437

Secondary Outcomes (16)

• Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response: Non-Responder Imputation (NRI)

  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

• Percentage of Participants Achieving ACR20 Response: Observed Case (OC)

  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

• Percentage of Participants Achieving ACR50 Response: NRI

  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

• Percentage of Participants Achieving ACR50 Response: OC

  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

• Percentage of Participants Achieving ACR70 Response: NRI

  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

Study Arms (2)

Filgotinib Darwin 1

EXPERIMENTAL

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.

Drug: Filgotinib

Filgotinib Darwin 2

EXPERIMENTAL

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.

Drug: Filgotinib

Interventions

Filgotinib DRUG

Administered as Oral Tablets

Also known as: GS-6034, GLPG0634

Filgotinib Darwin 1; Filgotinib Darwin 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Galapagos NV: lead
• Gilead Sciences: collaborator

Study Sites (111)

Arthro, Arthritis Care & Research

Gilbert, Arizona, United States

Location

Arizona Arthritis & Rheumatology Research PLLC

Mesa, Arizona, United States

Location

C.V. Mehta MD Medical Corp.

Hemet, California, United States

Location

Desert Medical Advances

Palm Desert, California, United States

Location

RASF Clinical Research Center

Boca Raton, Florida, United States

Location

Millenium Research

Ormond Beach, Florida, United States

Location

Lovelace Scientific Resources

Venice, Florida, United States

Location

Springfield Clinic

Springfield, Illinois, United States

Location

Klein and Associates MD, PA

Hagerstown, Maryland, United States

Location

Physicians East

Greenville, North Carolina, United States

Location

Health Research of Oklahoma

Oklahoma City, Oklahoma, United States

Location

Low County Rheumatology PA

Charleston, South Carolina, United States

Location

West Tennessee Research Institute

Jackson, Tennessee, United States

Location

Austin Rheumatology Research PA

Austin, Texas, United States

Location

Pioneer Research Solutions Inc

Houston, Texas, United States

Location

Atencion Integral en Reumatologa

Buenos Aires, Argentina

Location

CER Intituto Medico

Buenos Aires, Argentina

Location

Organizacion Medica de Investigaciones (OMI)

Buenos Aires, Argentina

Location

Instituto Reumatologico Strusberg

Córdoba, Argentina

Location

CIMeL Centro dee Investigacion Medico Lanus

Lanús, Argentina

Location

Instituto CAICI

Rosario, Argentina

Location

Instituto de Asistencia Reumatologia Integral - IARI

San Fernando, Argentina

Location

Centro Médico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Location

Flinders Medical Centre

Bedford Park, Flinders Drive, South Australia, Australia

Location

Monash Medical Centre

Clayton, Victoria, Australia

Location

Princess Alexandra Hospital

Woolloongabba, Australia

Location

Cliniques Universitaires St-Luc

Brussels, Belgium

Location

UZ Leuven

Leuven, Belgium

Location

University "Multiprofile Hospital for Active Treatment - Kaspela" LTD

Plovdiv, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Ruse

Rousse, Bulgaria

Location

Diagnostic Consultative Center "Sveta Anna" LTD

Sofia, Bulgaria

Location

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

Sofia, Bulgaria

Location

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

Sofia, Bulgaria

Location

Hospital Regional "Guillermo Grant Benavente"

Santiago, Chile

Location

Prosalud

Santiago, Chile

Location

Someal SA

Santiago, Chile

Location

Centro de Investigacion Clinica del Sur

Temuco, Chile

Location

Consulta Privada Dra. Ponce

Temuco, Chile

Location

Medicity S.A.S.

Bucaramanga, Santander Department, Colombia

Location

Circaribe S.A.S

Barranquilla, Colombia

Location

Centro de Investigacion en Reumatologia y Especialidades Medicas (CIREEM)

Bogotá, 110221, Colombia

Location

Riesgo De Fractura Cayre Ips7

Bogotá, 110221, Colombia

Location

Idearg Sas

Bogotá, Colombia

Location

Preventive Care SAS

Cundinamarca, Colombia

Location

Hospital Pablo Tobon Uribe

Medellín, Colombia

Location

Revmatologie S.R.O

Brno, Czechia

Location

Revmatologicka a interni ambulance

Kladno, Czechia

Location

Revmatologicka ambulance

Praha-Nusle, Czechia

Location

PV-Medical S.R.O.

Zlín, Czechia

Location

Hospitaux de Hautepierre

Strasbourg, France

Location

Schlossparkklinik - Akad. Lehrkrankenhaus Charite

Berlin, Germany

Location

MVZ Rheumatologie and Autoimmun Medizin HH GmbH

Hamburg, Germany

Location

Centro Clinico

Guatemala City, Guatemala

Location

Clinica de Especialidades Medicas

Guatemala City, Guatemala

Location

Clinica Medica Especializada en Reumatologia

Guatemala City, Guatemala

Location

Clinica Medica

Guatemala City, Guatemala

Location

Reuma S.A.

Guatemala City, Guatemala

Location

Reuma-Centro

Guatemala City, Guatemala

Location

Gyogyszervizs galo Kozpont Kft

Balatonfüred, Hungary

Location

QualiClinic Kft.

Budapest, Hungary

Location

Reumatologiai Kft.

Budapest, Hungary

Location

Markhot Ferenc Hospital, Rheumatology

Eger, Hungary

Location

Csolnoky Ferenc Hospital, Rheumatology

Veszprém, Hungary

Location

Carmel Medical Center

Haifa, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Ltd M&M Centr

Ādaži, Latvia

Location

SIA Arijas Ancane's Family Doctor

Baldone, Latvia

Location

Daugavpils Regional Hospital

Daugavpils, Latvia

Location

L. Atikes doktorats

Liepāja, Latvia

Location

'Bruninieku' polyclinic

Riga, Latvia

Location

Centro de Estudios de Investigacion Basica y Clinica, SC

Guadalajara, Mexico

Location

Centro Medico Dalinde

Mexico City, Mexico

Location

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

México, Mexico

Location

Clinstile, S.A. de C.V.

México, Mexico

Location

Hospital General de México

México, Mexico

Location

Hospital Universitario José E. Gonzalez

Monterrey, Mexico

Location

OSMO

Oaxaca City, Mexico

Location

IMSP Institutul de Cardiologie

Chisinau, Moldova

Location

Waikato Hospital

Hamilton, New Zealand

Location

Timaru Rheumatology Studies

Timaru, New Zealand

Location

NZOZ Osteo-Medic s.c.

Bialystok, Poland

Location

Centrum Medyczne Silesiana Sp. Z.o.o.

Bytom, Poland

Location

Centrum Medyczne Pratia Katowice

Katowice, Poland

Location

Centrum Medyczne Plejady

Krakow, Poland

Location

NZOZ "DOBRY LEKARZ" Specjalistyczne Poradnie Lekarskie

Krakow, Poland

Location

Specjalistyczne Centrum Medyczne Nowomed

Krakow, Poland

Location

NZOZ Przychodnia Lekarska "Eskulap"

Skierniewice, Poland

Location

Powiatowy Zaklad Opieki Zdrowotnej w Starachowicach

Starachowice, Poland

Location

NZOZ "Nasz Lekarz" Pratyka Grupowa Lekarzy Rodzinnychz

Torun, Poland

Location

AMED Medical Center

Warsaw, Poland

Location

Rheumatica Sp. Z.o.o.

Warsaw, Poland

Location

Spitalul Clinic Sfanta Maria

Bucharest, Romania

Location

Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Galati

Galati, Romania

Location

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

Moscow, Russia

Location

Scientific Research Institute of Rheumatology

Moscow, Russia

Location

City Clinical Hospital #5

Nizhny Novgorod, Russia

Location

GBOU VPO Orenburg State Medical University

Orenburg, Russia

Location

Ryazan State Medical University

Ryazan, Russia

Location

City Hospital #26

Saint Petersburg, Russia

Location

Regional Clinical Hospital

Saratov, Russia

Location

Vladimir Regional State Instituion of Healthcare

Vladimir, Russia

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, Spain

Location

Sanatorio Nuestra Señora de la Esperanza

A Coruña, Spain

Location

Hospital Parc Tauli

Sabadell, Spain

Location

Communal Institution of Healthcare - Kharkiv City Clinical Hospital #13

Kharkiv, Ukraine

Location

Kharkiv Medical Academy of Postgraduate Education, Department of Cardiology

Kharkiv, Ukraine

Location

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

Kharkiv, Ukraine

Location

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

Kherson, Ukraine

Location

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

Kiev, Ukraine

Location

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

Kyiv, Ukraine

Location

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

Vinnytsia, Ukraine

Location

Related Publications (8)

• 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).

  RESULT

• 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).

  RESULT

• 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)

  RESULT

• 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).

  RESULT

• 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.

  PMID: 33526618 RESULT

• 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.

  PMID: 39884731 DERIVED

• 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.

  PMID: 37747626 DERIVED

• 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.

  PMID: 36205910 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

GLPG0634

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Galapagos Medical Information
• Organization: Galapagos NV

medicalinfo@glpg.com

+32 15 342900

Study Officials

• Galapagos Study Director

  Galapagos NV

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2014
• First Posted: February 19, 2014
• Study Start: February 25, 2014
• Primary Completion: January 19, 2023
• Study Completion: January 19, 2023
• Last Updated: June 4, 2024
• Results First Posted: June 4, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

FR (1); PL (11); UA (7); US (15); CO (7); IL (2); MO (1); LA (5); ME (7); AU (3); BE (2); RO (2); ES (3); BU (5); CL (5); CZ (4); HU (5); NZ (2); RU (8); AR (8); GU (6); DE (2)