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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GLPG0634
Placebo
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Methotrexate inadequate responders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Rheumatology Associates of North Alabama, PC
  • Artho Care, Arthritis Care & Research P.C.
  • Arizona Arthritis & Rheumatology Research PLLC
  • C.V. Mehta MD Medical Corporation
  • Center for Innovative TherapyDivision of Rheumatology, UCSD
  • Desert Medical Advances
  • Desert Valley Medical Center
  • Infosphere Clinical Research, Inc.
  • RASF Clinical Research Center
  • Millennium Research
  • Lovelace Scientific Resources
  • Arthritis Center of North GA
  • Idaho Arthritis Center
  • The Arthritis Center
  • Professional Research Network of Kansas
  • Arthritis Treatment Center
  • Klein and Associates MD
  • Private practice
  • Mayo Clinic
  • Physicians East
  • Health Research of Oklahoma
  • Altoona Center Clinical Research
  • Austin Rheumatology Research PA
  • Arthritis Centers of Texas
  • Pioneer Research Solutions Inc
  • Crossroads Clinical Research, LLC
  • Seattle Rheumatology Associates, PLLC
  • Mountain State Clinical Research
  • Atencion Integral en Reumatologa
  • Rheumatology OMI
  • Instituto Reumatologico
  • Instituto Medico CER
  • Instituto de Asistencia Reumatologia Integral
  • Centro Médico Privado de Reumatología
  • Royal Prince Alfred Hospital
  • Monash Medical Centre
  • Repatriation General Hospital
  • Princess Alexandra Hospital
  • Medical University/ AKH Vienna/ Dep.of Rheumatology 6J
  • Cliniques Universitaires St-Luc
  • Hospital Brugmann
  • Rheuma Instituut
  • AZ Groeninge
  • UZ Leuven
  • CHU de Liège
  • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
  • MHAT Ruse AD
  • Clinic of Rheumatology MHAT
  • Diagnostic Consultative Center "Sveta Anna" LTD
  • National Transport Hospital "Tsar Boris" III
  • Rheumatology Clinic
  • Hospital Regional "Guillermo Grant Benavente"
  • Instituto Terapias Oncologicas Providencia
  • Prosalud
  • Someal SA
  • Centro de Investigacion Clínica del Sur Freire
  • Private Office
  • Centro Integral de Reumatologia de Caribe
  • Fundación del caribe para la investigación medica Fundación BIOS
  • Centro Integral de Reumatologia e Inmunologia SAS
  • Cirei Sas
  • Idearg S.A.S.
  • Medicity S.A.S.
  • Clinica de Arthritis Temprana S.A.S.
  • Preventive Care SAS
  • Hospital Pablo Tobon Uribe
  • Revmatologie S.R.O
  • Ambulance Revmatologie a Interniho Lekarstvi
  • Revmatologicka ambulance
  • Medical Plus, s.r.o.
  • PV-Medical
  • Hopitaux universitaires de Strasbourg
  • Charite Mitte, Rheumatologie Neue Therapien
  • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
  • Klinikum Goethe-Universität
  • Schwerpunktpraxis fuer Rheumatologie
  • Rheumazentrum Ruhrgebiet
  • Centro Medico
  • Clinica de Especialidades Medicas
  • Clinica Medica Especializada en Reumatologia
  • Clinica Medica
  • Reuma S.A.
  • Reuma-Centro
  • DRC
  • Budai Irgalmasrendi Korhaz
  • Qualiclinic Ltd
  • Revita Clinic
  • Markhot Ferenc Korhaz
  • Bekes Megyei Pandy Kalman Korhaz, Reumatologiai Osztaly
  • Csolnoky Ferenc County Hospital
  • Carmel Medical Center
  • Rambam Medical Center
  • Sheba Medical Center
  • M&M Centre Ltd.
  • Meda D
  • L. Atikes doktorats
  • "Bruninieku" polyclinic
  • Arija's Ancane's Family Doctor
  • Centro de Estudios de Investigacion Basica y Clinica, SC
  • Arké Estudios Clínicos
  • Clinstile, S.A. de C.V.
  • Hospital General de México
  • Accelerium Clinical Research
  • Hospital Universitario José E. González
  • Centro de Alta Especialidad en Reumatología e Investigación del Potosí, S.C.
  • IMSP Institutul de Cardiologie
  • North Shore hospital
  • Waikato Hospital
  • Timaru Rheumatology Studies
  • NZOZ Osteo-Medic s.c.
  • Silesiana Centrum Medyczne
  • Medica Pro Familia Sp. z o.o. S.K.A.
  • Centrum Medyczne Plejady
  • Nowomed
  • Nzoz "Dobry Lekarz"
  • NZOZ Przychodnia Lekarska "Eskulap"
  • NS ZOZ Medicus Bonus
  • Powiatowy Zakrad Opieki Zdrowotnej w Starachowicach
  • NZOZ Nasz Lekarz
  • AMED Medical Center
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu
  • I.M. Sechenov First Moscow State Medical University
  • Research Institute of Rheumatology RAMS
  • State University of Medicine and Dentistry
  • City Clinical Hospital 5
  • Ryazan State Medical University
  • City Hospital # 26
  • Vladimir Reg Clin Hosp
  • Hospital Reina Sofa
  • Complejo Hospitalario Universitario A Coruña
  • Hospital General Universitario de Elche
  • Hospital Universitario de Mostoles
  • Consorci Sanitari Parc Tauli
  • Hospital Infanta Luisa
  • City Hospital #5
  • V. Gusak Institute of Urgent and Recovery Surgery
  • City Hospital #13
  • City Hospital #8
  • Government Institution
  • Central Outpatient Hospital of Deanyanskyy Distric
  • Central regional polyclinic of Pechersk District
  • Municipal Institution Lutsk City Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Placebo

GLPG0634 50 mg QD

GLPG0634 100 mg QD

GLPG0634 200 mg QD

GLPG0634 25 mg BID

GLPG0634 50 mg BID

GLPG0634 100 mg BID

Arm Description

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.

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.

Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.

Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.

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.

Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.

Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.
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).
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 26, 2013
Last Updated
October 26, 2020
Sponsor
Galapagos NV
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1. Study Identification

Unique Protocol Identification Number
NCT01888874
Brief Title
Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
Acronym
DARWIN1
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
July 17, 2013 (Actual)
Primary Completion Date
February 18, 2015 (Actual)
Study Completion Date
May 14, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Methotrexate inadequate responders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
GLPG0634 50 mg QD
Arm Type
Experimental
Arm Description
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.
Arm Title
GLPG0634 100 mg QD
Arm Type
Experimental
Arm Description
Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Arm Title
GLPG0634 200 mg QD
Arm Type
Experimental
Arm Description
Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Arm Title
GLPG0634 25 mg BID
Arm Type
Experimental
Arm Description
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.
Arm Title
GLPG0634 50 mg BID
Arm Type
Experimental
Arm Description
Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Arm Title
GLPG0634 100 mg BID
Arm Type
Experimental
Arm Description
Participants received GLPG0634 100 mg capsules, orally, BID during Weeks 1 to 24.
Intervention Type
Drug
Intervention Name(s)
GLPG0634
Intervention Description
GLPG0634 capsules.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsules.
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12
Description
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).
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving an ACR20 Response at Week 24
Description
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.
Time Frame
Week 24
Title
Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
Description
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.
Time Frame
Weeks 1, 2, 4, 8, 12, and 24
Title
Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24
Description
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.
Time Frame
Weeks 1, 2, 4, 8, 12, and 24
Title
ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24
Description
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).
Time Frame
Weeks 1, 2, 4, 8, 12, and 24
Title
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
Description
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.
Time Frame
Weeks 1, 2, 4, 8, 12, and 24
Title
Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24
Description
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.
Time Frame
Weeks 2, 4, 8, 12, and 24
Title
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24
Description
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.
Time Frame
Baseline and Weeks 1, 2, 4, 8, 12, and 24
Title
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24
Description
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.
Time Frame
Baseline and Weeks 1, 2, 4, 8, 12, and 24
Title
Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24
Description
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.
Time Frame
Baseline and Weeks 4, 12, and 24
Title
Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24
Description
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.
Time Frame
Baseline and Weeks 4, 12, and 24

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
36205910
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.
Results Reference
derived
PubMed Identifier
31912462
Citation
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.
Results Reference
derived
PubMed Identifier
27993829
Citation
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.
Results Reference
derived

Learn more about this trial

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

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