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+6
+ Arthritis, Rheumatoid
+ Autoimmune Diseases
From 18 to 75 Years
+6 Eligibility Criteria
How is the trial designed
Treatment Study
Placebo-ControlledPhase 2
Interventional
Study Start: December 2003
Summary
Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
Last updated: January 27, 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
Principal SponsorWyeth is now a wholly owned subsidiary of Pfizer
Last updated: January 27, 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 DiseasesSkin and Connective Tissue Diseases
Criteria
3 inclusion criteria required to participate
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
3 exclusion criteria prevent from participating
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
ExperimentalCCI-779 1 mg dose to be taken orally daily up to 12 weeks.
Group II
ExperimentalCCI-779 2 mg dose to be taken orally daily up to 12 weeks.
Group III
ExperimentalCCI-779 4 mg dose to be taken orally daily up to 12 weeks.
Group IV
PlaceboPlacebo 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