CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 956 enrolled
Drug / intervention
CP-690,550 +2 moredrug
Likely dose
CP-690,550 5 mgfrom 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/NCT01039688
NCT01039688Phase 3Completed
CompareCT.gov

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

Pfizer·interventional·Posted Dec 25, 2009·Updated Apr 6, 2018

In Brief

A Phase 3 clinical trial evaluating CP-690,550 and Disease-modifying antirheumatic drug for Arthritis, Rheumatoid. Completed, enrolled 956 participants across 176 sites in 30 countries.

Detailed Summary

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Czechia, Dominican Republic, Germany, Hungary, India, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2009
Enrollment StartJan 1, 2010
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 16.5 years ago

Interventions

CP-690,550drug

Oral tablets administered at a dose of 5 mg BID for 24 months

CP-690,550drug

Oral tablets administered at a dose of 10 mg BID for 24 months

Disease-modifying antirheumatic drugdrug

Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months