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Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

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

Eligibility Criteria

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

Inclusion Criteria:

  • male or female subjects who are ≥18 years of age on the day of signing informed consent,
  • 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 shown an inadequate response in terms of either lack of efficacy or toxicity to MTX,
  • have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period.

Exclusion Criteria:

  • current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening,
  • current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; 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

  • Artho Care, Arthritis Care & Research P.C.
  • Arizona Arthritis & Rheumatology Research PLLC
  • Arizona Arthritis Rheum Res
  • Little Rock Diagnostic Clinic
  • C.V. Mehta MD Medical Corp.
  • Center for Innovative Therapy Division of Rheumatology, UCSD
  • Desert Medical Advances
  • Infosphere Clinical Research, Inc.
  • Lovelace Scientific Resources
  • Arthritis Center of North GA
  • The Arthritis Center
  • Klein and Associates MD
  • Private practice
  • Arthritis Center of Reno
  • New Jersey Physicians, LLC
  • Health research of Oklahoma
  • Altoona Center Clin Research
  • Low Country Rheumatology, PA
  • Arthritis Clinic
  • Austin Rheumatology Research PA
  • Pioneer Research Solutions Inc
  • Centro de Investigaciones Medicas Lanus
  • Instituto Centralizado de Asistencia e investigacion Clinica Integral
  • Centro Médico Privado de Reumatología
  • Royal Prince Alfred Hospital
  • Princess Alexandra Hospital
  • Rheumazentrum Favoriten
  • "Multiprofile Hospital for Active Treatment - Kaspela" LTD
  • Clinic of Rheumatology MHAT
  • Hospital Regional "Guillermo Grant Benavente"
  • Private Office
  • Fundación del Caribe para la Investigación Biomédica BIOS
  • Centro Integral de Reumatologia SAS
  • Cirei Sas
  • Idearg S.A.S.
  • Medicity S.A.S.
  • Preventive Care Ltda
  • Schlossparkklinik - Akad. Lehrkrankenhaus Charite
  • Schwerpunktpraxis fuer Rheumatologie
  • Clinica Médica Especializada en Medicina Interna
  • Reuma S.A.
  • Reuma-Centro
  • DRC
  • Qualiclinic Ltd
  • Revita Clinic
  • Csolnoky Ferenc County Hospital
  • L. Atikes doktorats
  • "Bruninieku" Polyclinic
  • Arké Estudios Clínicos S.A. de C.V.
  • Centro Medico Dalinde
  • Clinstile, S.A. de C.V.
  • Mexico Centre for Clinical Research
  • Hospital Universitario
  • Hospital de Especialidades
  • IMSP Institutul de Cardiologie
  • North Shore hospital
  • Timaru Rheumatology Studies
  • Silesiana Centrum Medyczne
  • Centrum Kliniczno
  • Medica Pro Familia Sp. z o.o. S.K.A.
  • Nowomed
  • Nzoz "Dobry Lekarz"
  • NZOZ Przychodnia Lekarska "Eskulap"
  • NZOZ Medicus Bonus
  • AMED Medical Center
  • Ars Rheumatica Sp. Z.o.o.
  • Wojewodzki Szpital Specjalistyczny we Wroclawiu
  • Ianuli Med Consult SRL
  • Sana Medical Center
  • Spitalul Clinic Sfanta Maria
  • Emergency County Hospital
  • Orenburg State Medical Academy
  • GUZ "Regional Clinical Hospital"
  • Vladimir Reg Clin Hosp
  • Hospital General Elche
  • Consorci Sanitari Parc Tauli
  • CICEC S.L.P Hospital Ntra.Sra.de la Esperanza
  • V. Gusak Institute of Urgent and Recovery Surgery
  • City Hospital #8
  • Municipal Hospital
  • Central Outpatient Hospital of Deanyanskyy Distric
  • Regional Clinical Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Placebo

GLPG0634 50 mg QD

GLPG0634 100 mg QD

GLPG0634 200 mg QD

Arm Description

Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD 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.

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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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). All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.

Full Information

First Posted
July 4, 2013
Last Updated
November 24, 2020
Sponsor
Galapagos NV
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1. Study Identification

Unique Protocol Identification Number
NCT01894516
Brief Title
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Official Title
Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks as Monotherapy to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate (MTX) Alone
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2013 (Actual)
Primary Completion Date
March 5, 2015 (Actual)
Study Completion Date
May 29, 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 who had an inadequate response to methotrexate were evaluated for improvement of disease activity (efficacy) when taking GLPG0634 as monotherapy (3 different doses - 50 milligram (mg), 100 mg and 200 mg once daily) 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 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, all participants on placebo and the participants on the 50 mg dose who had not achieved 20% improvement in swollen joint count (SJC66) and tender joint count (TJC68) were assigned (automatically via interactive web response system (IWRS)) to 100 mg once daily (QD) in a blinded fashion and continued treatment 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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received GLPG0634 matching placebo capsules, orally, once daily (QD) during Weeks 1 to 12 and GLPG0634 100 milligram (mg) QD 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.
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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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). All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
Time Frame
Weeks 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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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. All placebo participants switched to GLPG0634 treatment at Week 12 and were not included in the analysis of Week 24.
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: male or female subjects who are ≥18 years of age on the day of signing informed consent, 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 shown an inadequate response in terms of either lack of efficacy or toxicity to MTX, have agreed to be washed out from MTX for a period of at least 4 weeks before or during the Screening period. Exclusion Criteria: current therapy with any non-biological disease modifying anti-rheumatic drug (DMARD), with the exception of antimalarials, which must be at a stable dose for at least 12 weeks prior to Screening, current or previous RA treatment with a biologic DMARD, with the exception of biologic DMARDs: administered in a single clinical study setting, and; more than 6 months prior to Screening (12 months for rituximab or other B cell depleting agents), and; 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
Artho Care, Arthritis Care & Research P.C.
City
Gilbert
State/Province
Arizona
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research PLLC
City
Mesa
State/Province
Arizona
Country
United States
Facility Name
Arizona Arthritis Rheum Res
City
Phoenix
State/Province
Arizona
Country
United States
Facility Name
Little Rock Diagnostic Clinic
City
Little Rock
State/Province
Arkansas
Country
United States
Facility Name
C.V. Mehta MD Medical Corp.
City
Hemet
State/Province
California
Country
United States
Facility Name
Center for Innovative Therapy Division 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
Infosphere Clinical Research, Inc.
City
West Hills
State/Province
California
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
The Arthritis Center
City
Springfield
State/Province
Illinois
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
Arthritis Center of Reno
City
Reno
State/Province
Nevada
Country
United States
Facility Name
New Jersey Physicians, LLC
City
Clifton
State/Province
New Jersey
Country
United States
Facility Name
Health research of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Altoona Center Clin Research
City
Duncansville
State/Province
Pennsylvania
Country
United States
Facility Name
Low Country Rheumatology, PA
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Arthritis Clinic
City
Jackson
State/Province
Tennessee
Country
United States
Facility Name
Austin Rheumatology Research PA
City
Austin
State/Province
Texas
Country
United States
Facility Name
Pioneer Research Solutions Inc
City
Houston
State/Province
Texas
Country
United States
Facility Name
Centro de Investigaciones Medicas Lanus
City
Lanus
Country
Argentina
Facility Name
Instituto Centralizado de Asistencia e investigacion Clinica Integral
City
Rosario
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
Princess Alexandra Hospital
City
Woolloongabba
Country
Australia
Facility Name
Rheumazentrum Favoriten
City
Wien
Country
Austria
Facility Name
"Multiprofile Hospital for Active Treatment - Kaspela" LTD
City
Plovdiv
Country
Bulgaria
Facility Name
Clinic of Rheumatology MHAT
City
Sofia
Country
Bulgaria
Facility Name
Hospital Regional "Guillermo Grant Benavente"
City
Concepcion
Country
Chile
Facility Name
Private Office
City
Temuco
Country
Chile
Facility Name
Fundación del Caribe para la Investigación Biomédica BIOS
City
Barranquilla
Country
Colombia
Facility Name
Centro Integral de Reumatologia 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
Preventive Care Ltda
City
Chia
Country
Colombia
Facility Name
Schlossparkklinik - Akad. Lehrkrankenhaus Charite
City
Berlin
Country
Germany
Facility Name
Schwerpunktpraxis fuer Rheumatologie
City
Hamburg
Country
Germany
Facility Name
Clinica Médica Especializada en Medicina Interna
City
Guatemala City
Country
Guatemala
Facility Name
Reuma S.A.
City
Guatemala City
Country
Guatemala
Facility Name
Reuma-Centro
City
Guatemala City
Country
Guatemala
Facility Name
DRC
City
Balatonfüred
Country
Hungary
Facility Name
Qualiclinic Ltd
City
Budapest
Country
Hungary
Facility Name
Revita Clinic
City
Budapest
Country
Hungary
Facility Name
Csolnoky Ferenc County Hospital
City
Veszprem
Country
Hungary
Facility Name
L. Atikes doktorats
City
Liepaja
Country
Latvia
Facility Name
"Bruninieku" Polyclinic
City
Riga
Country
Latvia
Facility Name
Arké Estudios Clínicos S.A. de C.V.
City
Mexico
Country
Mexico
Facility Name
Centro Medico Dalinde
City
Mexico
Country
Mexico
Facility Name
Clinstile, S.A. de C.V.
City
Mexico
Country
Mexico
Facility Name
Mexico Centre for Clinical Research
City
Mexico
Country
Mexico
Facility Name
Hospital Universitario
City
Monterrey
Country
Mexico
Facility Name
Hospital de Especialidades
City
Oaxaca
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
Timaru Rheumatology Studies
City
Timaru
Country
New Zealand
Facility Name
Silesiana Centrum Medyczne
City
Bytom
Country
Poland
Facility Name
Centrum Kliniczno
City
Elblag
Country
Poland
Facility Name
Medica Pro Familia Sp. z o.o. S.K.A.
City
Katowice
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
NZOZ Medicus Bonus
City
Sroda Wielkopolska
Country
Poland
Facility Name
AMED Medical Center
City
Warsaw
Country
Poland
Facility Name
Ars Rheumatica Sp. Z.o.o.
City
Warszawa
Country
Poland
Facility Name
Wojewodzki Szpital Specjalistyczny we Wroclawiu
City
Wroclaw
Country
Poland
Facility Name
Ianuli Med Consult SRL
City
Bucharest
Country
Romania
Facility Name
Sana Medical Center
City
Bucuresti
Country
Romania
Facility Name
Spitalul Clinic Sfanta Maria
City
Bucuresti
Country
Romania
Facility Name
Emergency County Hospital
City
Galati
Country
Romania
Facility Name
Orenburg State Medical Academy
City
Orenburg
Country
Russian Federation
Facility Name
GUZ "Regional Clinical Hospital"
City
Saratov
Country
Russian Federation
Facility Name
Vladimir Reg Clin Hosp
City
Vladimir
Country
Russian Federation
Facility Name
Hospital General Elche
City
Elche
Country
Spain
Facility Name
Consorci Sanitari Parc Tauli
City
Sabadell
Country
Spain
Facility Name
CICEC S.L.P Hospital Ntra.Sra.de la Esperanza
City
Santiago De Compostella
Country
Spain
Facility Name
V. Gusak Institute of Urgent and Recovery Surgery
City
Donetsk
Country
Ukraine
Facility Name
City Hospital #8
City
Kharkiv
Country
Ukraine
Facility Name
Municipal Hospital
City
Kherson
Country
Ukraine
Facility Name
Central Outpatient Hospital of Deanyanskyy Distric
City
Kiev
Country
Ukraine
Facility Name
Regional Clinical Hospital
City
Vinnytsya
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
27993828
Citation
Kavanaugh A, Kremer J, Ponce L, Cseuz R, Reshetko OV, Stanislavchuk M, Greenwald M, Van der Aa A, Vanhoutte F, Tasset C, Harrison P. Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: results from a randomised, dose-finding study (DARWIN 2). Ann Rheum Dis. 2017 Jun;76(6):1009-1019. doi: 10.1136/annrheumdis-2016-210105. Epub 2016 Dec 19.
Results Reference
derived

Learn more about this trial

Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)

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