NCT00603512

Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan

A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Confirm Dose Responsiveness Following 12 Weeks of the Administration of CP-690,550 (4 Doses) or Placebo in Subjects With Active Rheumatoid Arthritis Inadequately Controlled With Methotrexate Alone

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4 dose regimens of CP-690,550, combined with methotrexate, for the treatment with active rheumatoid arthritis.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Placebo	0 mg BID, 3 blinded tablets administered BID for 12 weeks
DRUG	CP-690,550	10 mg BID, 3 blinded tablets administered BID for 12 weeks
DRUG	CP-690,550	1 mg BID, 3 blinded tablets administered BID for 12 weeks
DRUG	CP-690,550	3 mg BID, 3 blinded tablets administered BID for 12 weeks
DRUG	CP-690,550	5 mg BID, 3 blinded tablets administered BID for 12 weeks

Timeline

• Start date: 2008-01-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2008-01-29
• Last updated: 2013-01-25
• Results posted: 2013-01-25

Locations

18 sites across 1 country: Japan