A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

Phase 3 Completed 611 enrolled Pfizer

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This Phase 3 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 as monotherapy 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 the Phase 2 Rheumatoid Arthritis studies.

Timeline

Start: 2009-02
Primary completion: 2010-06
Completion: 2010-06

Outcome

Mixed primary results

registry analysis (superiority or other test); CP-690,550 10 mg vs Placebo; p <0.0001; Percent difference 39.04 (95% CI 29.12 to 48.95); NCT00814307 ↗

registry analysis (superiority or other test); CP-690,550 10 mg vs Placebo; p <.0001; Least squares mean difference -0.38 (95% CI -0.50 to -0.27); NCT00814307 ↗

registry analysis (superiority or other test); CP-690,550 10 mg vs Placebo; p = 0.0728; Percent difference 5.24 (95% CI -0.49 to 10.96); NCT00814307 ↗

Publications

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tofacitinib	Small molecule	5 mg	Oral
Subject	Tofacitinib	Small molecule	10 mg	Oral