Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy

• Status: Terminated
• Trial end date: 2005-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Everolimus; Methotrexate; Sirolimus

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