CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 800 enrolled
Drug / intervention
CP-690,550 +7 moredrug
Likely dose
CP-690,550 5 mg or 10 mg orally twice dailyAI-extracted
Key inclusion· 2
  • ✓Adults with moderate to severe rheumatoid arthritis
  • ✓Currently on a stable dose of methotrexate
Key exclusion· 4
  • ✕Pregnancy
  • ✕Severe acute or chronic medical conditions
  • ✕Serious infections
  • ✕Clinically significant laboratory abnormalities

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

Search/NCT00847613
NCT00847613Phase 3Completed
CompareCT.gov

Phase 3 Randomized, Double Blind, 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 Feb 19, 2009·Updated May 16, 2024

In Brief

A Phase 3 clinical trial evaluating CP-690,550 and Placebo for Arthritis, Rheumatoid. Completed, enrolled 800 participants across 115 sites in 15 countries.

Detailed Summary

This study is designed to provide safety and efficacy data to support the development of CP-690,550 in patients with moderate to severe rheumatoid arthritis on background of methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesAustralia, Brazil, Bulgaria, Canada, Colombia, Czechia, Greece, India, Japan, Mexico, Poland, South Korea, Taiwan, Ukraine, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 19, 2009
Enrollment StartMar 1, 2009
Primary CompletionApr 1, 2011
Study CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 17.4 years ago

Interventions

CP-690,550drug

Oral tablets administered at 5 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

CP-690,550drug

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

CP-690,550drug

Oral tablets administered at 10 mg BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

CP-690,550drug

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Placebodrug

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

CP-690,550drug

Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.

Placebodrug

Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.

CP-690,550drug

Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.