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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01894516
Registration number
NCT01894516
Ethics application status
Date submitted
4/07/2013
Date registered
10/07/2013
Date last updated
16/12/2020
Titles & IDs
Public title
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
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Scientific 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
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Secondary ID [1]
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GLPG0634-CL-204 (DARWIN2)
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GLPG0634
Treatment: Drugs - Placebo
Placebo comparator: Placebo - 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.
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.
Experimental: GLPG0634 100 mg QD - Participants received GLPG0634 100 mg capsules, orally, QD during Weeks 1 to 24.
Experimental: GLPG0634 200 mg QD - Participants received GLPG0634 200 mg capsules, orally, QD during Weeks 1 to 24.
Treatment: Drugs: GLPG0634
GLPG0634 capsules.
Treatment: Drugs: Placebo
Placebo capsules.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Achieving an American College of Rheumatology (ACR) 20 Response at Week 12
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Assessment method [1]
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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).
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Percentage of Participants Achieving an ACR20 Response at Week 24
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Assessment method [1]
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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.
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percentage of Participants Achieving an ACR50 Response at Weeks 1, 2, 4, 8, 12, and 24
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Assessment method [2]
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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.
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Timepoint [2]
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Weeks 1, 2, 4, 8, 12, and 24
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Secondary outcome [3]
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Percentage of Participants Achieving an ACR70 Response at Weeks 1, 2, 4, 8, 12, and 24
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Assessment method [3]
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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.
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Timepoint [3]
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Weeks 1, 2, 4, 8, 12, and 24
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Secondary outcome [4]
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ACR N% Improvement (ACR-N) Response at Weeks 1, 2, 4, 8, 12, and 24
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Assessment method [4]
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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.
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Timepoint [4]
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Weeks 1, 2, 4, 8, 12, and 24
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Secondary outcome [5]
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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
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Assessment method [5]
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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.
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Timepoint [5]
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Weeks 1, 2, 4, 8, 12, and 24
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Secondary outcome [6]
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Percentage of Participants Achieving ACR/EULAR Remission at Weeks 2, 4, 8, 12, and 24
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Assessment method [6]
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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.
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Timepoint [6]
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Weeks 4, 8, 12, and 24
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Secondary outcome [7]
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Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 1, 2, 4, 8, 12, and 24
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline and Weeks 1, 2, 4, 8, 12, and 24
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Secondary outcome [8]
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 1, 2, 4, 8, 12, and 24
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline and Weeks 1, 2, 4, 8, 12, and 24
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Secondary outcome [9]
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Change From Baseline in Quality of Life Using the Functional Assessment of Chronic Illness Therapy (FACIT) at Weeks 4, 12, and 24
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Assessment method [9]
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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.
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Timepoint [9]
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Baseline and Weeks 4, 12, and 24
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Secondary outcome [10]
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Change From Baseline in Quality of Life Using the Short Form-36 (SF-36) Scores at Weeks 4, 12, and 24
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Assessment method [10]
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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.
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Timepoint [10]
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Baseline and Weeks 4, 12, and 24
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
8/10/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/05/2015
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Sample size
Target
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Accrual to date
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Final
287
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment postcode(s) [1]
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- Camperdown
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Recruitment postcode(s) [2]
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- Woolloongabba
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Recruitment outside Australia
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Ukraine
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Vinnytsya
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Galapagos NV
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Address
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT01894516
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Trial related presentations / 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. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7. 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. 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.
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Public notes
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Contacts
Principal investigator
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Galapagos Study Director
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Galapagos NV
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Contact person for scientific queries
No information has been provided regarding IPD availability
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Study protocol
https://cdn.clinicaltrials.gov/large-docs/16/NCT01894516/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/16/NCT01894516/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01894516
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