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

NCT ID: NCT00076206

Last Updated: 2015-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2005-08-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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A

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

Group Type EXPERIMENTAL

CCI-779

Intervention Type DRUG

B

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

Group Type EXPERIMENTAL

CCI-779

Intervention Type DRUG

C

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

Group Type EXPERIMENTAL

CCI-779

Intervention Type DRUG

D

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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CCI-779

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role lead

Principal Investigators

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Medical Monitor, MD

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

Other Identifiers

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3066A3-206

Identifier Type: -

Identifier Source: org_study_id