CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 611 enrolled
Drug / intervention
CP-690,550 +3 moredrug
Likely dose
CP-690,550 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00814307
NCT00814307Phase 3Completed
CompareCT.gov

Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of CP-690,550 Monotherapy In Patients With Active Rheumatoid Arthritis

Pfizer·interventional·Posted Dec 24, 2008·Updated Jan 18, 2013

In Brief

A Phase 3 clinical trial evaluating CP-690,550 and Placebo for Arthritis, Rheumatoid. Completed, enrolled 611 participants across 95 sites in 16 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesBrazil, Bulgaria, Chile, Colombia, Czechia, Dominican Republic, Germany, India, Malaysia, Mexico, Philippines, Poland, Puerto Rico, Russia, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2008
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.5 years ago

Interventions

CP-690,550drug

5mg CP-690,550 BID PO for 6 months

CP-690,550drug

10 mg CP-690,550 BID PO for 6 months

Placebodrug

Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit

Placebodrug

Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit