Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease

Study Identifier
M04-691
CT.gov Identifier
NCT00105300
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
  • Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Males and females between the ages of 18 and 75 who are diagnosed with mild to moderate Crohn's disease (defined by a CDAI [Crohn's Disease Activity Index] score of 220 and 450) - Normal lab parameters - Are willing to give informed consent - Have previously used and either were intolerant to or lost response to infliximab
    Exclusion Criteria:
    - History of certain types of cancer - Diagnosis of ulcerative colitis - Pregnant female or breast feeding subjects - Known obstructive strictures - Surgical bowel resection in the past 6 months - History of listeria, human immunodeficiency virus (HIV), central nervous system demyelinating disease or untreated TB (tuberculosis) - History of poorly controlled medical conditions - Specific doses and durations of Crohn's medications - Subjects that have previously used infliximab and have never clinically responded unless primary non-response was due to a treatment limiting reaction to infliximab

    Protocol Summary

    The goal of this study is to test whether adalimumab can induce clinical remission in

    subjects with active Crohn's disease who have been initially treated with infliximab and

    either lost response or discontinued its use as a result of intolerance to the drug.

    Study Locations

    Location
    Status
    Location
    Clinical Research Associates
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Capitol Gastroenterology Consultants Medical Group, Inc.
    Roseville, California, United States, 95661
    Status
    Not applicable
    Location
    Medical Associates Research Group
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Sharp Rees-Stealy Medical Group
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    SMC-Trauma Research
    Englewood, Colorado, United States, 80113
    Status
    Not applicable
    Location
    Clinical Research of West Florida, Inc
    Clearwater, Florida, United States, 33765
    Status
    Not applicable
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