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 - ND

• Conditions: MedDRA version: 9.1Level: PTClassification code 10039073; Rheumatoid arthritis

• Registration Number: EUCTR2009-014296-40-IT
• Lead Sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 396

Inclusion Criteria

- Active rheumatoid arthritis (RA) - Ongoing treatment with an adequate and stable dose of methotrexate - In the opinion of the investigator, at least one approved TNF-inhibiting biologic agent administered in accordance with its labeling recommendations was inadequately effective and/or not tolerated. - Must be at least 18 years of age - No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) - For traditional DMARDS, minimum washout criteria apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Any prior treatment with non B lymphocyte-selective lymphocyte depleting agents/therapies - Blood dyscrasias - Estimated GFR less than 40 ml/min - AST or ALT more than 1.5 times the upper limit of normal at screening visit - Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease - History of any other autoimmune rheumatic disease other than Sjogren s syndrome - History of an infected joint prosthesis at any time, with the prosthesis still in situ. - History of any lymphoproliferative disorder - History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug - History of any infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug - A history of recurrent (more than one episode) herpes zoster, disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex. - . A patient who was vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, expects to be vaccinated or exposed to these vaccines during treatment, or during the 6 weeks following discontinuation of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified