Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease

Study Identifier
M04-690
CT.gov Identifier
NCT00195715
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:
    - Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691 (NCT00105300) protocol to be eligible for this study - Diagnosis of Crohn's disease - Willing and able to give informed consent
    Exclusion Criteria:
    - Diagnosis of ulcerative colitis - Women cannot be pregnant or breastfeeding - Previous history of listeria infection or untreated tuberculosis - Previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix

    Protocol Summary

    To evaluate the long-term maintenance of response, safety and tolerability of repeated

    administration of adalimumab in subjects with Crohn's disease who participated in and

    successfully completed Protocol M02-404 or Protocol M04-691.

    Study Locations

    Location
    Status
    Location
    Site Ref # / Investigator 1894
    Huntsville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Site Ref # / Investigator 1895
    Jacksonville, Alabama, United States, 35801
    Status
    Not applicable
    Location
    Site Ref # / Investigator 1787
    La Jolla, California, United States, 92037
    Status
    Not applicable
    Location
    Site Ref # / Investigator 1902
    Roseville, California, United States, 95661
    Status
    Not applicable
    Location
    Site Ref # / Investigator 1824
    San Diego, California, United States, 92123
    Status
    Not applicable
    Location
    Site Ref # / Investigator 1891
    San Diego, California, United States, 92123
    Status
    Not applicable
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