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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01888874
Registration number
NCT01888874
Ethics application status
Date submitted
26/06/2013
Date registered
28/06/2013
Date last updated
17/11/2020
Titles & IDs
Public title
Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
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Scientific 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
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Secondary ID [1]
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2012-003635-31
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Secondary ID [2]
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GLPG0634-CL-203 (DARWIN1)
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Universal Trial Number (UTN)
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Trial acronym
DARWIN1
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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, 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.
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.
Experimental: GLPG0634 25 mg BID - Participants received GLPG0634 25 mg capsules, orally, BID during Weeks 1 to 12. Participants who were responders (having at least 20% improvement on TJC68 and SJC66) remained on 25 mg BID while nonresponders were re-randomized to 50 mg BID during Weeks 13 to 24.
Experimental: GLPG0634 50 mg BID - Participants received GLPG0634 50 mg capsules, orally, BID during Weeks 1 to 24.
Experimental: GLPG0634 100 mg BID - Participants received GLPG0634 100 mg capsules, orally, BID 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.
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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.
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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).
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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.
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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.
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Timepoint [6]
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Weeks 2, 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.
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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.
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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.
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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.
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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
* 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.
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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 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.
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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
17/07/2013
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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
14/05/2015
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Sample size
Target
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Accrual to date
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Final
599
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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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Monash Medical Centre - Clayton
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Recruitment hospital [3]
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Repatriation General Hospital - Daw Park
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Recruitment hospital [4]
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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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- Clayton
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Recruitment postcode(s) [3]
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- Daw Park
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Recruitment postcode(s) [4]
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- Woolloongabba
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Idaho
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Illinois
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Kansas
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Maryland
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Michigan
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Minnesota
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North Carolina
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Oklahoma
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Cordoba
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Argentina
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Quilmes
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Argentina
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San Fernando
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Argentina
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Tucuman
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Austria
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Belgium
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Hasselt
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Kortrijk
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Belgium
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Plovdiv
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Bulgaria
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Ruse
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Chile
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Temuco
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Colombia
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Brno
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Uherske Hradiste
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Zlin
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Herne
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Guatemala
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Guatemala
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Hungary
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Balatonfured
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Eger
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Haifa
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Israel
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Ramat Gan
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Latvia
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Adazi
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Latvia
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Latvia
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Latvia
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Guadalajara
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Mexico
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Mexico
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Mexico
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Monterrey
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Mexico
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San Luis Potosi
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Moldova, Republic of
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Chisinau
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Auckland
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Hamilton
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New Zealand
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Timaru
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Poland
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Bialystok
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Bytom
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Katowice
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Krakow
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Skierniewice
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Sroda Wielkopolska
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Starachowice
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Torun
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Warsaw
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Wroclaw
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Russian Federation
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State/province [82]
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Moscow
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Russian Federation
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State/province [83]
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Nizhniy Novgorod
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Russian Federation
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State/province [84]
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Ryazan
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Russian Federation
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St Petersburg
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Country [86]
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Russian Federation
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State/province [86]
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Vladimir
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Country [87]
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Spain
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State/province [87]
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Cordoba
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Country [88]
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Spain
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State/province [88]
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Coruña
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Spain
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State/province [89]
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Elche
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Spain
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Mostoles
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Spain
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State/province [91]
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Sabadell
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Spain
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State/province [92]
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Sevilla
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Country [93]
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Ukraine
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State/province [93]
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Donetsk
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Ukraine
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State/province [94]
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Kharkiv
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Ukraine
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Kiev
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Country [96]
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Ukraine
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State/province [96]
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Kyiv
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Country [97]
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Ukraine
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State/province [97]
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Lutsk
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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 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.
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Trial website
https://clinicaltrials.gov/study/NCT01888874
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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. 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.
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Public notes
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Contacts
Principal investigator
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Galapagos Study Director
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Address
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Galapagos NV
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Fax
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/74/NCT01888874/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/74/NCT01888874/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/NCT01888874
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