Phase 2 Clinical Study in Rheumatoid Arthritis With an Investigational Oral p38 MAP Kinase Inhibitor VX-702
Phase 2
Completed
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00205478
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief Summary
The purpose of this study is to assess the clinical activity and safety of two doses of VX-702 compared to placebo in subjects with moderate to severe Rheumatoid Arthritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Adults with active rheumatoid arthritis for greater than 6 months and evidence of inflammation.
Exclusion Criteria
- Subjects who have conditions precluding the use of cytokine inhibitors or subjects who require DMARDs other than hydroxychloroquine or sulfasalazine are excluded.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary endpoint for the study is the ACR20 response at Week 12.
- Secondary Outcome Measures
Name Time Method The ACR50 and ACR70 responses at 12 weeks will also be assessed as well as other measures.
Trial Locations
- Locations (42)
Medical University - Sofia
🇧🇬Sofia, Bulgaria
Military Medical Academy - Sofia
🇧🇬Sofia, Bulgaria
Transport Hospital
🇧🇬Sofia, Bulgaria
MBAL "Stara Zagora" EAD
🇧🇬Stara Zagora, Bulgaria
Thalassotherapia
🇭🇷Opatija, Croatia
KBC Osijek Ambulanta za bol
🇭🇷Osijek, Croatia
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
University Hospital U Sv.Anny
🇨🇿Brno, Czech Republic
University Hospital Kralovske Vinohrady
🇨🇿Praha 10, Czech Republic
SZZ-Jizni Mesto II
🇨🇿Praha 11, Czech Republic
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