At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 264 enrolled
Drug / intervention
CP-690,550 +3 moredrug
Likely dose
CP-690,550 5 mg, 15 mg, or 30 mg orally twice daily for 6 weeksAI-extracted
Key inclusion· 1
- ✓History of inadequate response to 1–4 conventional DMARDs (sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, azathioprine, or 6-mercaptopurine)
Key exclusion· 1
- ✕Current therapy with any DMARD or biologic agent
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Compare 3 Dose Levels Of CP-690,550 Versus Placebo, Administered Orally Twice Daily (BID) For 6 Weeks, In The Treatment Of The Signs And Symptoms Of Subjects With Active Rheumatoid Arthritis
In Brief
A Phase 2 clinical trial evaluating CP-690,550 and Placebo for Rheumatoid Arthritis. Completed, enrolled 264 participants across 60 sites in 9 countries.
Detailed Summary
The study's objective is to compare the efficacy of 3 dose levels of oral CP-690,550 monotherapy (5 mg, 15 mg, and 30 mg twice daily \[BID\]) versus placebo administered over 6 weeks for the treatment of the signs and symptoms of subjects with active rheumatoid arthritis (RA).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Brazil, Canada, Germany, Italy, Mexico, Slovakia, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
First PostedSep 2005
Primary CompletionJun 2006
TodayJul 2026
First PostedSep 7, 2005
Enrollment StartJan 1, 2005
Primary CompletionJun 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 20.8 years ago
Interventions
CP-690,550drug
Oral tablets administered at a dose of 5 mg BID for 6 weeks
CP-690,550drug
Oral tablets administered at a dose of 15 mg BID for 6 weeks
CP-690,550drug
30 mg BID for 6 weeks
Placeboother
Placebo tablets