Remission in Subjects With Crohn's Disease, 1 Year Phase

Study Identifier
M02-433
CT.gov Identifier
NCT00055497
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
  • Double-blind (DB) adalimumab placebo
  • DB adalimumab 40 mg eow
  • DB adalimumab 40 mg ew
  • OL adalimumab 40 mg
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    Inclusion: - Patient must have successfully completed the induction study NCT00055523 - Diagnosis of Crohn's disease - Willing and able to give informed consent Exclusion: - Diagnosis of ulcerative colitis - Pregnancy or breastfeeding - Previous use of infliximab or other anti-TNF antagonists - Previous history of active tuberculosis or listeria infection - Previous history of cancer other than successfully treated skin cancer

    Protocol Summary

    The objectives were: (1) To demonstrate the efficacy of adalimumab in the maintenance of

    clinical remission up to 56 weeks in participants with Crohn's disease who participated in

    NCT00055523; (2) To delineate the safety of adalimumab when administered to participants with

    Crohn's disease up to 56 weeks.

    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
    Wake Research Associates
    Weston, Florida, United States, 33331
    Status
    Not applicable
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