A3921046 rheumatoid arthritis - background DMARDS
Research type
Research Study
Full title
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
IRAS ID
18445
Sponsor organisation
ICON Clinical Research (UK) Ltd
Eudract number
2008-008337-11
Clinicaltrials.gov Identifier
Research summary
Study A3921046 is a Phase 3 study comparing CP-690,550 versus placebo in patients with active rheumatoid arthritis (RA) who are already being treated with stable doses of other arthritis medications, (DMARDs.) CP-690,550 is an oral medication that specifically targets the immune system. This study is intended to provide evidence for control of RA disease activity with improvement in symptoms, such as swelling and pain, and with improvement in every-day functions and activities. The study will also look at long term (1 year) safety of CP-690,550 given in combination with other background arthritis medications. This study will require 9 visits to the clinic over one year. During this study, patients will get either CP-690,550 pills 5 mg twice a day, CP-690,550 pills 10 mg twice a day, or placebo twice a day. One out of 5 patients will get placebo and 4 out of 5 people will get CP-690,550 for the first 3 months of the study. At Month 3, patients on placebo who do not show improvement in their painful and swollen joint counts will be switched to CP-690,550 study medication. At Month 6 all patients will be assigned to CP-690,550 study medication for the remainder of the study. This study will be conducted at approximately 120 sites in 23 countries throughout the world. Study A3921046 is being sponsored by Pfizer Inc.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
09/H1208/26
Date of REC Opinion
10 Jun 2009
REC opinion
Further Information Favourable Opinion