CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 4,488 enrolled
Drug / intervention
CP-690,550 +1 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/NCT00413699
NCT00413699Phase 3Completed
CompareCT.gov

A Long-term, Open-label Follow-up Study Of Tofacitinib (Cp-690,550) For Treatment Of Rheumatoid Arthritis

Pfizer·interventional·Posted Dec 20, 2006·Updated Oct 30, 2018

In Brief

A Phase 3 clinical trial evaluating CP-690,550 for Arthritis, Rheumatoid. Completed, enrolled 4,488 participants across 469 sites in 43 countries.

Detailed Summary

The purpose of this study is to determine the long-term effectiveness and safety of CP-690,550 for the treatment of rheumatoid arthritis. Subjects are eligible for this study only after participating in another "qualifying" study of CP-690,550 A sub-study will be conducted within the A3921024 study, this study will evaluate the immune response to pneumococcal and influenza vaccines in patients receiving CP-690,550

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesArgentina, Australia, Austria, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czechia, Denmark, Dominican Republic, Finland, France, Germany, Greece, Hungary, India, Ireland, Italy, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 20, 2006
Enrollment StartFeb 5, 2007
Primary CompletionNov 30, 2016
Study CompletionOct 26, 2017
TodayJul 2, 2026
Enrollment to primary: 9.8 yearsPosted 19.5 years ago

Interventions

CP-690,550drug

5 mg PO BID open label; may increase to 10 mg PO BID to provide greater control of RA if no related AEs are present. May be off study drug temporarily for up to 28 days for mild to moderate AEs.

CP-690,550drug

10 mg PO BID open label; may decrease to 5 mg PO BID for mild to moderate AEs. May be off study drug temporarily for up to 28 days for mild to moderate AEs.