Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease

Study Identifier
M02-404
CT.gov Identifier
NCT00077779
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
    CSR.ORG
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion: - Males and females between the ages of 18 and 75 who are diagnosed with moderate to severe Crohn's Disease defined by a CDAI score of >= 220 and <= 450, normal laboratory parameters, - are willing and able to give informed consent, and - are able to self-inject or have a designee or healthcare professional who can inject the study medication. Exclusion: - History of certain types of cancer, diagnosis of ulcerative colitis, - female or breast feeding subjects, - surgical bowel resection(s) with in the past 6 months, - history of listeria, - human immunodeficiency virus (HIV), - central nervous system demyelinating disease or untreated TB, - history of a poorly controlled medical condition, - unsuccessful response to infliximab or any anti-TNF agent use in the past.

    Protocol Summary

    The purpose of this study is to test whether Adalimumab (at two different doses) can induce

    and maintain clinical remission in subjects with active Crohn's disease when compared to

    placebo (a substance containing no medication)

    Study Locations

    Location
    Status
    Location
    Thornton Hospital Reumatology Division
    La Jolla, California, United States, 92037-0943
    Status
    Not applicable
    Location
    UCSF San Francisco General Hospital
    San Francisco, California, United States, 94110
    Status
    Not applicable
    Location
    Cal-West, Inc.
    San Francisco, California, United States, 94117
    Status
    Not applicable
    Location
    Western States Clinical Research
    Arvada, Colorado, United States, 80002
    Status
    Not applicable
    Location
    Gastroenterology Associates of Fairfield County
    Bridgeport, Connecticut, United States, 06606
    Status
    Not applicable
    Location
    Clinical Research of West Florida, Inc.
    Clearwater, Florida, United States, 33765
    Status
    Not applicable
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