Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1) (DARWIN1)

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

Participants suffering from active rheumatoid arthritis despite continued treatment with methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 (3 different doses - 50 milligram [mg], 100 mg and 200 mg daily -, each evaluated as once daily [QD] and twice daily [BID] regimen) or matching placebo for 24 weeks.

•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 and dose regiments of GLPG0634 administration on participants' disability, fatigue, and quality of life were evaluated.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: GLPG0634

Detailed Description

• Treatment duration was 24 weeks in total.
• However, at Week 12, participants on placebo who did not achieve a 20% improvement in swollen joint count(SJC66) and tender joint count (TJC68) were re-randomized (automatically via interactive voice/web response [IXRS]) to treatment to receive GLPG0634 100 mg QD or 50 mg BID doses in a blinded fashion, participants on 50 mg QD who had not achieved a 20% improvement in SJC66 and TJC68 were assigned to 100 mg QD and participants on 25 mg BID. who did not achieve a 20% improvement in SJC66 and TJC68 were assigned to 50 mg BID. All continued the study until Week 24.
• Participants in the other groups maintained their randomized treatment until Week 24.

• Study Type: Interventional
• Enrollment (Actual): 599
• Phase: Phase 2

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Atencion Integral en Reumatologa
  • Buenos Aires, Argentina
    • Rheumatology OMI
  • Cordoba, Argentina
    • Instituto Reumatologico
  • Quilmes, Argentina
    • Instituto Médico CER
  • San Fernando, Argentina
    • Instituto de Asistencia Reumatologia Integral
  • Tucuman, Argentina
    • Centro Medico Privado de Reumatologia
• Australia
  • Camperdown, Australia
    • Royal Prince Alfred Hospital
  • Clayton, Australia
    • Monash Medical Centre
  • Daw Park, Australia
    • Repatriation General Hospital
  • Woolloongabba, Australia
    • Princess Alexandra Hospital
• Austria
  • Wien, Austria
    • Medical University/ AKH Vienna/ Dep.of Rheumatology 6J
• Belgium
  • Brussels, Belgium
    • Cliniques Universitaires St-Luc
  • Brussels, Belgium
    • Hospital Brugmann
  • Hasselt, Belgium
    • Rheuma Instituut
  • Kortrijk, Belgium
    • AZ Groeninge
  • Leuven, Belgium
    • UZ Leuven
  • Liege, Belgium
    • CHU de Liège
• Bulgaria
  • Plovdiv, Bulgaria
    • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
  • Ruse, Bulgaria
    • MHAT Ruse AD
  • Sofia, Bulgaria
    • Diagnostic Consultative Center "Sveta Anna" LTD
  • Sofia, Bulgaria
    • Clinic of Rheumatology MHAT
  • Sofia, Bulgaria
    • National Transport Hospital "Tsar Boris" III
  • Sofia, Bulgaria
    • Rheumatology Clinic
• Chile
  • Concepcion, Chile
    • Hospital Regional "Guillermo Grant Benavente"
  • Santiago, Chile
    • PROSALUD
  • Santiago, Chile
    • Someal SA
  • Santiago, Chile
    • Instituto Terapias Oncologicas Providencia
  • Temuco, Chile
    • Private Office
  • Temuco, Chile
    • Centro de Investigacion Clínica del Sur Freire
• Colombia
  • Barranquilla, Colombia
    • Centro Integral de Reumatologia de Caribe
  • Barranquilla, Colombia
    • Fundación del caribe para la investigación medica Fundación BIOS
  • Bogota, Colombia
    • Cirei Sas
  • Bogota, Colombia
    • Idearg S.A.S.
  • Bogota, Colombia
    • Centro Integral de Reumatologia e Inmunologia SAS
  • Bucaramanga, Colombia
    • Medicity S.A.S.
  • Cali, Colombia
    • Clinica de Arthritis Temprana S.A.S.
  • Cundinamarca, Colombia
    • Preventive Care SAS
  • Medellin, Colombia
    • Hospital Pablo Tobón Uribe
• Czechia
  • Brno, Czechia
    • Revmatologie S.R.O
  • Kladno, Czechia
    • Ambulance Revmatologie a Interniho Lekarstvi
  • Praha-Nusle, Czechia
    • Revmatologicka ambulance
  • Uherske Hradiste, Czechia
    • MEDICAL PLUS, s.r.o.
  • Zlin, Czechia
    • PV-Medical
• France
  • Strasbourg, France
    • Hopitaux Universitaires de Strasbourg
• Germany
  • Berlin, Germany
    • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
  • Berlin, Germany
    • Charite Mitte, Rheumatologie Neue Therapien
  • Frankfurt, Germany
    • Klinikum Goethe-Universität
  • Hamburg, Germany
    • Schwerpunktpraxis fuer Rheumatologie
  • Herne, Germany
    • Rheumazentrum Ruhrgebiet
• Guatemala
  • Guatemala, Guatemala
    • Reuma-Centro
  • Guatemala City, Guatemala
    • Reuma S.A.
  • Guatemala City, Guatemala
    • Centro Médico
  • Guatemala City, Guatemala
    • Clinica de Especialidades Medicas
  • Guatemala City, Guatemala
    • Clinica Medica Especializada en Reumatologia
  • Guatemala City, Guatemala
    • Clinica Medica
• Hungary
  • Balatonfured, Hungary
    • DRC
  • Budapest, Hungary
    • Budai Irgalmasrendi Kórház
  • Budapest, Hungary
    • Qualiclinic Ltd
  • Budapest, Hungary
    • Revita Clinic
  • Eger, Hungary
    • Markhot Ferenc Korhaz
  • Gyula, Hungary
    • Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
  • Veszprem, Hungary
    • Csolnoky Ferenc County Hospital
• Israel
  • Haifa, Israel
    • Rambam Medical Center
  • Haifa, Israel
    • Carmel Medical Center
  • Ramat Gan, Israel
    • Sheba Medical Center
• Latvia
  • Adazi, Latvia
    • M&M Centre Ltd.
  • Daugavplis, Latvia
    • Meda D
  • Liepaja, Latvia
    • L. Atikes doktorats
  • Riga, Latvia
    • "Bruninieku" polyclinic
  • Riga, Latvia
    • Arija's Ancane's Family Doctor
• Mexico
  • Guadalajara, Mexico
    • Centro de Estudios de Investigacion Basica y Clinica, Sc
  • Mexico, Mexico
    • Clinstile, S.A. de C.V.
  • Mexico, Mexico
    • Hospital General de Mexico
  • Mexico, Mexico
    • Arké Estudios Clínicos
  • Monterrey, Mexico
    • Accelerium Clinical Research
  • Monterrey, Mexico
    • Hospital Universitario José E. Gonzalez
  • San Luis Potosi, Mexico
    • Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.
• Moldova, Republic of
  • Chisinau, Moldova, Republic of
    • IMSP Institutul de Cardiologie
• New Zealand
  • Auckland, New Zealand
    • North Shore Hospital
  • Hamilton, New Zealand
    • Waikato Hospital
  • Timaru, New Zealand
    • Timaru Rheumatology Studies
• Poland
  • Bialystok, Poland
    • NZOZ Osteo-Medic s.c.
  • Bytom, Poland
    • Silesiana Centrum Medyczne
  • Katowice, Poland
    • Medica Pro Familia Sp. z o.o. S.K.A.
  • Krakow, Poland
    • Centrum Medyczne Plejady
  • Krakow, Poland
    • Nowomed
  • Krakow, Poland
    • Nzoz "Dobry Lekarz"
  • Skierniewice, Poland
    • NZOZ Przychodnia Lekarska "Eskulap"
  • Sroda Wielkopolska, Poland
    • NS ZOZ Medicus Bonus
  • Starachowice, Poland
    • Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
  • Torun, Poland
    • NZOZ Nasz Lekarz
  • Warsaw, Poland
    • AMED Medical Center
  • Wroclaw, Poland
    • Wojewodzki Szpital Specjalistyczny We Wroclawiu
• Russian Federation
  • Moscow, Russian Federation
    • I.M. Sechenov First Moscow State Medical University
  • Moscow, Russian Federation
    • Research Institute of Rheumatology RAMS
  • Moscow, Russian Federation
    • State University of Medicine and Dentistry
  • Nizhniy Novgorod, Russian Federation
    • City Clinical Hospital 5
  • Ryazan, Russian Federation
    • Ryazan State Medical University
  • St Petersburg, Russian Federation
    • City Hospital # 26
  • Vladimir, Russian Federation
    • Vladimir Reg Clin Hosp
• Spain
  • Cordoba, Spain
    • Hospital Reina Sofa
  • Coruña, Spain
    • Complejo Hospitalario Universitario A Coruna
  • Elche, Spain
    • Hospital General Universitario de Elche
  • Mostoles, Spain
    • Hospital Universitario de Móstoles
  • Sabadell, Spain
    • Consorci Sanitari Parc Taulí
  • Sevilla, Spain
    • Hospital Infanta Luisa
• Ukraine
  • Donetsk, Ukraine
    • V. Gusak Institute of Urgent and Recovery Surgery
  • Donetsk, Ukraine
    • City Hospital #5
  • Kharkiv, Ukraine
    • City Hospital #8
  • Kharkiv, Ukraine
    • City Hospital #13
  • Kharkiv, Ukraine
    • Government Institution
  • Kiev, Ukraine
    • Central Outpatient Hospital of Deanyanskyy Distric
  • Kyiv, Ukraine
    • Central regional polyclinic of Pechersk District
  • Lutsk, Ukraine
    • Municipal Institution Lutsk City Clinical Hospital
• United States
  • Alabama
    • Huntsville, Alabama, United States
      • Rheumatology Associates of North Alabama, PC
  • Arizona
    • Gilbert, Arizona, United States
      • Artho Care, Arthritis Care & Research P.C.
    • Phoenix, Arizona, United States
      • Arizona Arthritis & Rheumatology Research PLLC
  • California
    • Hemet, California, United States
      • C.V. Mehta MD Medical Corporation
    • La Jolla, California, United States
      • Center for Innovative TherapyDivision of Rheumatology, UCSD
    • Palm Desert, California, United States
      • Desert Medical Advances
    • Victorville, California, United States
      • Desert Valley Medical Center
    • West Hills, California, United States
      • Infosphere Clinical Research, Inc.
  • Florida
    • Boca Raton, Florida, United States
      • RASF Clinical Research Center
    • Ormond Beach, Florida, United States
      • Millennium Research
    • Venice, Florida, United States
      • Lovelace Scientific Resources
  • Georgia
    • Gainesville, Georgia, United States
      • Arthritis Center of North GA
  • Idaho
    • Meridian, Idaho, United States
      • Idaho Arthritis Center
  • Illinois
    • Springfield, Illinois, United States
      • The Arthritis Center
  • Kansas
    • Wichita, Kansas, United States
      • Professional Research Network of Kansas
  • Maryland
    • Frederick, Maryland, United States
      • Arthritis Treatment Center
    • Hagerstown, Maryland, United States
      • Klein and Associates MD
  • Michigan
    • Lansing, Michigan, United States
      • Private Practice
  • Minnesota
    • Rochester, Minnesota, United States
      • Mayo Clinic
  • North Carolina
    • Greenville, North Carolina, United States
      • Physicians East
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
      • Health Research of Oklahoma
  • Pennsylvania
    • Duncansville, Pennsylvania, United States
      • Altoona Center Clinical Research
  • Texas
    • Austin, Texas, United States
      • Austin Rheumatology Research PA
    • Dallas, Texas, United States
      • Arthritis Centers Of Texas
    • Houston, Texas, United States
      • Pioneer Research Solutions Inc
    • Victoria, Texas, United States
      • Crossroads Clinical Research, LLC
  • Washington
    • Seattle, Washington, United States
      • Seattle Rheumatology Associates, PLLC
  • West Virginia
    • Clarksburg, West Virginia, United States
      • Mountain State Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 received MTX for ≥6 months and have been on a stable dose (15 to 25 mg/week) of MTX for at least 4 weeks prior to Screening and willing to continue on their current regimen for the duration of the study. Stable doses of MTX as low as 10 mg/week are allowed when there is documented evidence of intolerance or safety issues at higher doses.

Exclusion Criteria:

• current therapy with any disease-modifying anti-rheumatic drugs (DMARD) other than MTX,
• current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs administered in a single clinical study setting more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: GLPG0634; GLPG0634 capsules.
Experimental: GLPG0634 100 mg QD; Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.	Drug: GLPG0634; GLPG0634 capsules.
Experimental: GLPG0634 200 mg QD; Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.	Drug: GLPG0634; GLPG0634 capsules.
Placebo Comparator: Placebo; Participants received GLPG0634 matching placebo capsules, orally, twice daily (BID) during Weeks 1 to 12. Participants who were responders (having at least 20 percent [%] improvement on TJC68 and SJC66) remained on placebo while nonresponders were re-randomized to GLPG0634 100 milligram (mg) once daily (QD) or 50 mg BID during Weeks 13 to 24.	Drug: Placebo; Placebo capsules.
Experimental: GLPG0634 25 mg BID; Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.	Drug: GLPG0634; GLPG0634 capsules.
Experimental: GLPG0634 50 mg BID; Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.	Drug: GLPG0634; GLPG0634 capsules.
Experimental: GLPG0634 100 mg BID; Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.	Drug: GLPG0634; GLPG0634 capsules.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12	The American College of Rheumatology (ACR) response is a measurement of improvement in multiple disease assessment criteria. The ACR20 response is defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in tender TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain visual analog scale (VAS) (taken from the Health Assessment Questionnaire - Disability Index [HAQ-DI]), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used (ie, to impute a missing response, the participant was assumed to be a non-responder).	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving an ACR20 Response at Week 24	ACR20 response was defined as: 1) ≥ 20% improvement from baseline in SJC66, and 2) ≥ 20% improvement from baseline in TJC68, and 3) ≥ 20% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used.	Week 24
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24	ACR50 response was defined as: 1) ≥ 50% improvement from baseline in SJC66, and 2) ≥ 50% improvement from baseline in TJC68, and 3) ≥ 50% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI) 2. Patient's Global Assessment of Disease Activity VAS 3. Physician's Global Assessment of Disease Activity VAS 4. Total HAQ-DI score 5. CRP. Non-responder imputation was used.	Weeks 1, 2, 4, 8, 12, and 24
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24	ACR70 response: 1) ≥ 70% improvement from baseline in SJC66, and 2) ≥ 70% improvement from baseline in TJC68, and 3) ≥ 70% improvement from baseline in at least 3 of the following 5 items: 1. Pain VAS (taken from the HAQ-DI), 2. Patient's Global Assessment of Disease Activity VAS, 3. Physician's Global Assessment of Disease Activity VAS, 4. Total HAQ-DI score, and 5. CRP. Non-responder imputation was used.	Weeks 1, 2, 4, 8, 12, and 24
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24	The ACR-N is the smallest percentage improvement in swollen and tender joints and the median of the remaining 5 core parameters, and is expected to be more sensitive to change than the ACR20, ACR50 or ACR70. It is a number varying between 0 and 100, with higher numbers indicating less severity of symptoms. Last observation carried forward (LOCF) algorithm was used (ie, to impute a missing value, the last preceding nonmissing value was used).	Weeks 1, 2, 4, 8, 12, and 24
Percentage of Participants With Disease Activity Score 28 Joints Corrected for CRP (DAS28 (CRP)) European League Against Rheumatism (EULAR) Response at Weeks 1, 2, 4, 8, 12, and 24	DAS28 (CRP) was categorized into EULAR response categories (none, moderate, good) as follows: None = Actual DAS28 (CRP) ≤ 3.2, > 3.2 to ≤ 5.1, or > 5.1 AND Improvement in DAS28 (CRP) from baseline ≤ 6.0 or > 0.6 to ≤ 1.2; Moderate = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2, Actual DAS28 (CRP) > 3.2 to ≤ 5.1 or > 5.1 AND Improvement in DAS28 (CRP) from baseline > 1.2, or Actual DAS28 (CRP) > 3.2 to ≤ 5.1 AND Improvement in DAS28 (CRP) from baseline > 0.6 to ≤ 1.2; Good = Actual DAS28 (CRP) ≤ 3.2 AND Improvement in DAS28 (CRP) from baseline > 1.2. LOCF algorithm was used.	Weeks 1, 2, 4, 8, 12, and 24
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24	A participant's disease activity status can be defined as being in remission when scores on the TJC28, SJC28, CRP (actual value in mg/dL) and Patient Global Assessment of Disease Activity (cm) are all ≤ 1. Non-responder imputation was used.	Weeks 2, 4, 8, 12, and 24
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24	The SDAI is the numerical sum of 5 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), Physician's Global Assessment of Disease Activity (in cm), and CRP (mg/dL). The SDAI was categorized as follows: • High disease activity: SDAI > 26 • Moderate disease activity: 11 to 26 • Low disease activity: 3.3 to 11 • Remission: ≤ 3.3. LOCF algorithm was used. The SDAI total score ranges from 0 to approximately 86.	Baseline and Weeks 1, 2, 4, 8, 12, and 24
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24	The CDAI is the SDAI modified to exclude CRP and is the sum of the 4 outcome parameters: TJC28, SJC28, Patient Global Assessment of Disease Activity (in cm), and Physician's Global Assessment of Disease Activity (in cm). The CDAI was be categorized as follows: • High disease activity: > 22 • Moderate disease activity: 10 to 22 • Mild disease activity: 2.8 to 10 • Remission: ≤ 2.8. LOCF algorithm was used. The CDAI total score ranges from 0 to approximately 76.	Baseline and Weeks 1, 2, 4, 8, 12, and 24
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24	FACIT-Fatigue scale is a 13-item questionnaire, each scored on a 5-point scale: 0 (Not at all) to 4 (Very much). The larger the participant's response to the questions (with the exception of 2 negatively stated that are scored reversely), the greater the fatigue. The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worse score) to 52 (better score), with a higher score indicating a better quality of life. LOCF algorithm was used.	Baseline and Weeks 4, 12, and 24
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24	The SF-36 is a 36-item questionnaire measuring 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health). Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status. Two summary scale scores were computed based on weighted combinations of the 8 domain scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). LOCF algorithm was used.	Baseline and Weeks 4, 12, and 24

Collaborators and Investigators

• Sponsor: Galapagos NV

Publications and helpful links

General Publications

• 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. 2022 Oct 7. doi: 10.1007/s40744-022-00494-1. Online ahead of print.
• 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.
• Westhovens R, Taylor PC, Alten R, Pavlova D, Enriquez-Sosa F, Mazur M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral JAK1 selective inhibitor, is effective in combination with methotrexate (MTX) in patients with active rheumatoid arthritis and insufficient response to MTX: results from a randomised, dose-finding study (DARWIN 1). Ann Rheum Dis. 2017 Jun;76(6):998-1008. doi: 10.1136/annrheumdis-2016-210104. Epub 2016 Dec 19.

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2013
• Primary Completion (Actual): February 18, 2015
• Study Completion (Actual): May 14, 2015

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: June 27, 2013
• First Posted (Estimate): June 28, 2013

Study Record Updates

• Last Update Posted (Actual): November 17, 2020
• Last Update Submitted That Met QC Criteria: October 26, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Methotrexate inadequate responders
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: GLPG0634-CL-203 (DARWIN1); 2012-003635-31 (EudraCT Number)