A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease

Study Identifier
M04-729
CT.gov Identifier
NCT00445939
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
  • placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    15 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - Crohn's Disease Activity Index (CDAI) score of >= 220 and <= 450 - If subjects have previously been administered infliximab, subjects who discontinued use due to a loss of response or intolerance to infliximab therapy
    Exclusion Criteria:
    - Ulcerative colitis or indeterminate colitis - History of cancer, lymphoma, leukemia or lymphoproliferative disease, active tuberculosis (TB), or Human immunodeficiency virus (HIV) - Body weight is below 30 kg - Surgical bowel resections within the past 6 months - Females who are pregnant or breast-feeding or considering becoming pregnant during the study

    Protocol Summary

    The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the

    induction of clinical remission in Japanese subjects with Crohn's disease.

    Study Locations

    Location
    Status
    Location
    Aichi, Japan
    Status
    Not applicable
    Location
    Chiba, Japan
    Status
    Not applicable
    Location
    Ehime, Japan
    Status
    Not applicable
    Location
    Fukuoka, Japan
    Status
    Not applicable
    Location
    Hiroshima, Japan
    Status
    Not applicable
    Location
    Hokkaido, Japan
    Status
    Not applicable
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