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

Phase 2

Terminated

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Placebo; Drug: CCI-779

• Registration Number: NCT00076206
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-12
• Study First Submitted: 2004-01-15
• Study First Submitted QC: 2004-01-16
• Study First Posted: 2004-01-19
• Primary Completion: 2005-08
• Study Completion: 2005-08
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-07
• Last Update Posted: 2015-12-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
D	Placebo	Placebo dose to be taken orally daily up to 12 weeks.
A	CCI-779	CCI-779 1 mg dose to be taken orally daily up to 12 weeks.
B	CCI-779	CCI-779 2 mg dose to be taken orally daily up to 12 weeks.
C	CCI-779	CCI-779 4 mg dose to be taken orally daily up to 12 weeks.