Suspended

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

What is being tested

CCI-779

+ Placebo

Drug

Who is being recruted

Arthritis+5

+ Arthritis, Rheumatoid

+ Autoimmune Diseases

From 18 to 75 Years

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2

Interventional

Study Start: December 2003

See protocol details

Summary

Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 2003

Actual date on which the first participant was enrolled.

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.

Official TitleA 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

NCT00076206

Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer

Last updated: January 14, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisArthritis, RheumatoidAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

4 intervention groups are designated in this study

25% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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

Group II

Experimental

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

Group III

Experimental

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

Group IV

Placebo

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has no location dataSave this study to your profile to know when the location data is available.

SuspendedNo study centers