A Double-Blind, Parallel, Placebo-Controlled, Randomized Study to Evaluate the Efficacy and Safety of 3 Different Oral Dose Levels (1, 2, And 4 Mg) of CCI-779 in Subjects With Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

Wyeth is now a wholly owned subsidiary of Pfizer0 sitesDecember 2003

ConditionsRheumatoid Arthritis

InterventionsCCI-779 Placebo

DrugsCCI-779 Placebo

Overview

Phase: Phase 2
Intervention: CCI-779
Conditions: Rheumatoid Arthritis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Status: Terminated
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of this study is to compare the therapeutic response and safety of 3 oral dose levels of CCI-779, with placebo in subjects with active rheumatoid arthritis (RA) who have been receiving stable doses of methotrexate (MTX) for at least 8 weeks.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

August 2005

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

•Meet American College of Rheumatology (ACR) criteria for RA
•Have active RA consisting of ≥ 6 swollen and ≥ 6 painful joints
•ACR functional class I-III
•Exclusion Criteria
•At screening the subject's prior medications are reviewed. (Prior history of disease-modifying antirheumatic drug (DMARD) use is recorded, including the start and stop dates of the most recently taken DMARDs)
•Significant concurrent medical diseases
•Abnormal chest radiograph, including findings consistent with interstitial pneumonitis, granulomatous disease, or pleural effusion and/or infiltration