Safety & Efficacy of CP-690,550 in patients with Rheumatoid Arthritis
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 Methotrexate with inadequate response to TNF Inhibitors
IRAS ID
30624
Contact name
David Scott
Sponsor organisation
Pfizer Inc
Eudract number
2009-014296-40
Clinicaltrials.gov Identifier
Research summary
Rheumatoid Arthritis (RA) is an autoimmune disease (where the bodys own immune system attacks its own cells), which is primarily linked to the inflammation and destruction of joints. This in turn leads to progressive disability in sufferers and can contribute to psychological issues. There is no cure for RA at present. Current treatment for RA includes DMARDs (Disease-Modifying AntiRheumatic Drugs). These are used to try and control disease activity, to ease the signs and symptoms, reduce the loss of physical function (including the rate of joint damage), to optimise quality of life and if possible to induce a complete remissionof RA. Most DMARDs however do not adequately minimise or prevent the pregession of joint damage or help to increase quality of life for the patient. They are also associated with clinical tolerability and/or safety issues. Biologic DMARDs such as TNF (Tumor necrosis factor) inhibitors do appear to be more effective and successfully halt or slow joint damage. However there are issues around the administration route and lack of efficacy with continued use. This study aims to compare the efficacy of oral CP-690,550 at 2 doses with a placebo in patients who are on stable background methotrexate treatment (measured by ACR20 response rates at month 3) for the treatment of signs and symptoms of RA in patients who have moderate to severe RA and who have inadequate response to previous treatment with TNFi.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
09/H0405/62
Date of REC Opinion
5 Jan 2010
REC opinion
Further Information Favourable Opinion