NCT00960440

Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

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 Methotrexate With Inadequate Response To TNF Inhibitors

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 399 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test if CP-690,550 is safe and effective in rheumatoid arthritis patients taking methotrexate who have an inadequate response to tumor necrosis factor inhibitor treatment.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	CP-690,550	Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
DRUG	CP-690,550	Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
DRUG	Placebo	Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
DRUG	CP-690,550	Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
DRUG	Placebo	Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
DRUG	CP-690,550	Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2009-08-17
• Last updated: 2018-12-19
• Results posted: 2013-01-10

Locations

92 sites across 14 countries: United States, Australia, Austria, Belgium, Brazil, Canada, France, Germany, Ireland, Italy, Puerto Rico, South Korea, Spain, Taiwan