Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease

Study Identifier
M14-233
CT.gov Identifier
NCT02499783
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
Download document(s)
Statistical Analysis Plan
Available Language(s): English
Download document(s)
Scientific Result Summary
Available Language(s): English
Download document(s)

Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
  • adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 70 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subjects of Chinese descent with full Chinese parentage. * Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0. * Crohn's Disease Activity Index (CDAI) greater than or equal to 220 and less than or equal to 450 despite treatment with oral corticosteroids and/or immunosuppressants. * Subject has a negative Tuberculosis (TB) Screening Assessment. * Subject has elevated high sensitivity C-reactive protein (hs-CRP) during the Screening Period.
    Exclusion Criteria:
    * Subject with ulcerative colitis or indeterminate colitis. * Subject who has had a surgical bowel resection within the past 6 months or who is planning any resection at any time point in the future. * Subject with an ostomy or ileoanal pouch. * Subject who has short bowel syndrome. * Subject with symptomatic known obstructive strictures. * Subject with an internal or external fistula (with the exception of an anal fistula without abscess). * Active, or chronic or recurring infections, or active tuberculosis.

    Protocol Summary

    This study will evaluate the efficacy and safety of adalimumab induction and maintenance treatment in subjects with moderately to severely active Crohn's disease in China.

    Study Locations

    No locations found.