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

NCT00076206

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: CCI-779
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: A
    CCI-779 1 mg dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: CCI-779
  • Experimental: B
    CCI-779 2 mg dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: CCI-779
  • Experimental: C
    CCI-779 4 mg dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: CCI-779
  • Placebo Comparator: D
    Placebo dose to be taken orally daily up to 12 weeks.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2005
Actual Primary Completion Date August 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00076206
Other Study ID Numbers  ICMJE 3066A3-206
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Medical Monitor, MDWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP