NCT00856544

A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 795 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with 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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	CP-690,550	Film coated tablet, 5 mg PO BID, 1 year
DRUG	CP-690,550	Film coated tablet, 10 mg PO BID, 1 year
DRUG	Placebo	Film coated tablet, 1 tablet PO BID, 3-6 months
DRUG	Placebo	Film coated tablet, 1 tablet PO BID, 3-6 months

Timeline

• Start date: 2009-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2009-03-05
• Last updated: 2013-01-10
• Results posted: 2013-01-10

Locations

133 sites across 20 countries: United States, Australia, Chile, China, Colombia, Croatia, Denmark, Finland, Germany, Greece, Malaysia, Mexico, Poland, Russia, Slovakia, Spain, Sweden, Thailand, United Kingdom, Venezuela