NCT00847613

A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 800 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	CP-690,550	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.
DRUG	CP-690,550	Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.
DRUG	CP-690,550	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.
DRUG	CP-690,550	Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.
DRUG	Placebo	Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
DRUG	CP-690,550	Oral tablets administered at 5 mg BID daily through the end of the study during the double-blind, active-extension period.
DRUG	Placebo	Oral placebo tablets administered BID daily for 6 months (nonresponders advance to second intervention at 3 months) during the double-blind, placebo-controlled period.
DRUG	CP-690,550	Oral tablets administered at 10 mg BID daily through the end of the study during the double-blind, active-extension period.

Timeline

• Start date: 2009-03-01
• Primary completion: 2011-04-01
• Completion: 2012-02-01
• First posted: 2009-02-19
• Last updated: 2024-05-16
• Results posted: 2013-01-09

Locations

115 sites across 15 countries: United States, Australia, Brazil, Bulgaria, Canada, Colombia, Czechia, Greece, India, Japan, Mexico, Poland, South Korea, Taiwan, Ukraine