NCT00550446

A Phase 2 Study For Patients With A Physician's Diagnosis Of Rheumatoid Arthritis

A Phase 2b, Randomized, Double Blind, Placebo Controlled Active Comparator, Multicenter Study To Compare 5 Dose Regimens Of CP- 690,550 And Adalimumab Versus Placebo, Administered For 6 Months In The Treatment Of Subjects With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 386 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the effectiveness and safety, over 6 months, of 5 doses of CP-690,550 for the treatment of adults with active rheumatoid arthritis. Five out of seven subjects will receive CP-690,550. One out of seven will receive adalimumab (Humira®) and one out of seven will only receive inactive substances (placebo.)

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	Adalimumab	40mg subcutaneous injections every other week for 6 injections during week 0-10 with oral placebo BID. Subjects switched to CP-690,550 at week 12.
DRUG	CP-690-550	15 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
DRUG	CP-690-550	10 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
DRUG	CP-690-550	5 mg BID oral plus 6 placebo subcutaneous injections (week 0-10)
DRUG	CP-690,550	3 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
DRUG	CP-690,550	1 mg BID PO plus 6 placebo subcutaneous injections (week 0-10)
DRUG	Placebo	Placebo by mouth plus 6 placebo subcutaneous injections (week 0-10)

Timeline

• Start date: 2007-09-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2007-10-29
• Last updated: 2013-01-03
• Results posted: 2013-01-03

Locations

63 sites across 15 countries: United States, Brazil, Bulgaria, Chile, Croatia, Czechia, Germany, Greece, Hungary, Italy, Mexico, Romania, Slovakia, South Korea, Ukraine