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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CCI-779
Placebo
Sponsored by
Wyeth is now a wholly owned subsidiary of Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    A

    B

    C

    D

    Arm Description

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    January 15, 2004
    Last Updated
    December 7, 2015
    Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00076206
    Brief Title
    Study Evaluating CCI-779 in Active Rheumatoid Arthritis on Concomitant Methotrexate Therapy
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2015
    Overall Recruitment Status
    Terminated
    Study Start Date
    December 2003 (undefined)
    Primary Completion Date
    August 2005 (Actual)
    Study Completion Date
    August 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Wyeth is now a wholly owned subsidiary of Pfizer

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatoid Arthritis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    A
    Arm Type
    Experimental
    Arm Description
    CCI-779 1 mg dose to be taken orally daily up to 12 weeks.
    Arm Title
    B
    Arm Type
    Experimental
    Arm Description
    CCI-779 2 mg dose to be taken orally daily up to 12 weeks.
    Arm Title
    C
    Arm Type
    Experimental
    Arm Description
    CCI-779 4 mg dose to be taken orally daily up to 12 weeks.
    Arm Title
    D
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo dose to be taken orally daily up to 12 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    CCI-779
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Medical Monitor, MD
    Organizational Affiliation
    Wyeth is now a wholly owned subsidiary of Pfizer
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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