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

Wyeth

Status and phase: Terminated; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: CCI-779

Study type: Interventional

Funder types: Industry

Identifiers

NCT00076206

3066A3-206

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

A

Experimental group

Description:

CCI-779 1 mg dose to be taken orally daily up to 12 weeks.

Treatment:

Drug: CCI-779

B

Experimental group

Description:

CCI-779 2 mg dose to be taken orally daily up to 12 weeks.

Treatment:

Drug: CCI-779

C

Experimental group

Description:

CCI-779 4 mg dose to be taken orally daily up to 12 weeks.

Treatment:

Drug: CCI-779

D

Placebo Comparator group

Description:

Placebo dose to be taken orally daily up to 12 weeks.

Treatment:

Drug: Placebo