A Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
Phase 2
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00395577
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to assess the safety and effects of VX-702 in subjects with moderate to severe rheumatoid arthritis and who are taking the drug methotrexate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
Inclusion Criteria
- Adult patients 18 to 75 years of age with active RA
- Must have been taking MTX for at least 6 months
- No concurrent DMARD treatment (other than a stable dose of MTX)
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Exclusion Criteria
- Planned major surgery (e.g., joint replacement) within the duration of the treatment period of the study
- Treated with intra-articular injections of corticosteroids within 28 days prior to Day 1
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method To evaluate the effects of VX-702 administered with concomitant methotrexate (MTX), and MTX alone
- Secondary Outcome Measures
Name Time Method To evaluate the safety and tolerability of VX-702 administered with concomitant MTX, and MTX alone
Trial Locations
- Locations (2)
Call For Information
🇸🇮Ljubljana, Slovenia
Call for Information
🇵🇱Torun, Poland