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

Study Identifier
M02-403
CT.gov Identifier
NCT00055523
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 (D2E7)
    • Phase
    CSR.ORG
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion: - Diagnosis of Crohn's disease - CDAI score at baseline of between 220 and 450 - Normal laboratory parameters - Willing and able to give informed consent Exclusion: - Diagnosis of ulcerative colitis - Women cannot be pregnant or breastfeeding - No previous use of infliximab or other anti-TNF antagonists - No previous history of tuberculosis or listeria infection - No previous history of cancer other than successfully treated skin cancer

    Protocol Summary

    Purpose of the study is to test whether adalimumab can induce clinical remission in subjects

    with active Crohn's disease when compared to placebo (an inactive substance)

    Study Locations

    Location
    Status
    Location
    Gastroenterology Associates of the East Bay
    Berkeley, California, United States, 94705
    Status
    Not applicable
    Location
    Long Beach Gastroenterology Assoc.
    Long Beach, California, United States, 90806
    Status
    Not applicable
    Location
    Sharp Rees-Stealy Medical Group
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Gastroenterology Assoc. of Fairfield Co.
    Bridgeport, Connecticut, United States, 06606
    Status
    Not applicable
    Location
    Cleveland Clinic Florida
    Weston, Florida, United States, 33331
    Status
    Not applicable
    Location
    Shafran Gastroenterology Center
    Winter Park, Florida, United States, 32789
    Status
    Not applicable
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