Status:
COMPLETED
Dose-finding Study of GLPG0634 as add-on to Methotrexate in Active Rheumatoid Arthritis Participants (DARWIN1)
Lead Sponsor:
Galapagos NV
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 do...
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-ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 14 2015
Estimated Enrollment :
599 Patients enrolled
Trial Details
Trial ID
NCT01888874
Start Date
July 17 2013
End Date
May 14 2015
Last Update
November 17 2020
Active Locations (142)
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1
Rheumatology Associates of North Alabama, PC
Huntsville, Alabama, United States
2
Artho Care, Arthritis Care & Research P.C.
Gilbert, Arizona, United States
3
Arizona Arthritis & Rheumatology Research PLLC
Phoenix, Arizona, United States
4
C.V. Mehta MD Medical Corporation
Hemet, California, United States