NCT01039688

Comparing The Effectiveness And Safety Of 2 Doses Of An Experimental Drug, CP-690,550, To Methotrexate (MTX) In Patients With Rheumatoid Arthritis Who Have Not Previously Received MTX

Phase 3 Randomized, Double-blind Study Of The Efficacy And Safety Of 2 Doses Of Cp-690,550 Compared To Methotrexate In Methotrexate Navie Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 956 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to compare the effectiveness of the experimental drug, CP-690,550, to methotrexate in preventing joint damage and improving symptoms of rheumatoid arthritis. This study will also compare the safety of CP-690,550 with methotrexate.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	CP-690,550	Oral tablets administered at a dose of 5 mg BID for 24 months
DRUG	CP-690,550	Oral tablets administered at a dose of 10 mg BID for 24 months
DRUG	Disease-modifying antirheumatic drug	Oral capsules,administered as 10 mg per week for 4 weeks titrated to 15 mg per week for 4 weeks, then titrated to 20 mg week for 24 months

Timeline

• Start date: 2010-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2009-12-25
• Last updated: 2018-04-06
• Results posted: 2018-04-06

Locations

176 sites across 30 countries: United States, Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Czechia, Dominican Republic, Germany, Hungary, India, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Puerto Rico, Russia, Slovakia, South Korea, Spain, Sweden, Taiwan, Thailand, Ukraine