CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 717 enrolled
Drug / intervention
CP 690,550 +4 moredrug
Likely dose
CP-690,550 5 mg twice daily orally or 10 mg twice daily orally for 12 monthsAI-extracted
Key inclusion· 5
  • ✓Diagnosis of RA based on ACR 1987 Revised Criteria
  • ✓Inadequate response to methotrexate with active disease: ≥6 joints tender/painful on motion AND ≥6 joints swollen
  • ✓Elevated inflammatory markers: ESR >28 mm (Westergren) OR CRP >7 mg/L
  • ✓Stable methotrexate dose of 7.5–25 mg weekly and washed out of all other DMARDs
Key exclusion· 8
  • ✕Blood dyscrasias: Hemoglobin <9 g/dL, Hematocrit <30%, WBC <3,000/mm³, ANC <1,200/mm³, or platelets <100,000/L
  • ✕History of other autoimmune rheumatic disease (except Sjögren's syndrome)
  • ✕Malignancy or history of malignancy
  • ✕Recent serious infection: hospitalization, parenteral antimicrobials, or clinically significant infection within 6 months prior to first dose

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00853385
NCT00853385Phase 3Completed
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Phase 3 Randomized, Double-Blind, Active Comparator, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP 690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

Pfizer·interventional·Posted Mar 2, 2009·Updated Jan 18, 2013

In Brief

A Phase 3 clinical trial evaluating CP 690,550, CP-690,550, and 2 other interventions for Rheumatoid Arthritis. Completed, enrolled 717 participants across 125 sites in 21 countries.

Detailed Summary

This is a comparative study of CP 690,550, Humira (adalimumab) and placebo on background methotrexate in patients with Rheumatoid Arthritis. The study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day on background methotrexate in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in Rheumatoid Arthritis. An active comparator, adalimumab, is also included.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Bosnia and Herzegovina, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Finland, Germany, Mexico, Philippines, Poland, Slovakia, South Korea, Spain, Thailand, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 2, 2009
Enrollment StartMay 1, 2009
Primary CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago

Interventions

CP 690,550drug

tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months

CP-690,550drug

tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months

Placeboother

placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Placeboother

tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months

Biologic TNFibiological

placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months