Status:
COMPLETED
Dose-finding Study of GLPG0634 as Monotherapy in Active Rheumatoid Arthritis (RA) Participants (DARWIN2)
Lead Sponsor:
Galapagos NV
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 monothera...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 8 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 29 2015
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT01894516
Start Date
October 8 2013
End Date
May 29 2015
Last Update
December 16 2020
Active Locations (82)
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1
Artho Care, Arthritis Care & Research P.C.
Gilbert, Arizona, United States
2
Arizona Arthritis & Rheumatology Research PLLC
Mesa, Arizona, United States
3
Arizona Arthritis Rheum Res
Phoenix, Arizona, United States
4
Little Rock Diagnostic Clinic
Little Rock, Arkansas, United States