Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Two Treatment Modules in Chinese Subjects With Moderate to Severe Crohn's Disease

Study Identifier
M14-232
CT.gov Identifier
NCT02015793
EudraCT Identifier
Not available
EUCTIS ID
Not available
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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 for adalimumab
    • Phase
    Phase 2
    Sex
    Female & Male
    Age
    18 - 70 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    1. Subjects of Chinese descent with full Chinese parentage. 2. Diagnosis of Crohn's disease (CD) for at least 3 months prior to Week 0 confirmed by endoscopy, radiologic evaluation, and/or histology during the Screening Period. 3. Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450 despite treatment with oral corticosteroids and/or immunosuppressants. 4. Subject has a negative Tuberculosis (TB) Screening Assessment.
    Exclusion Criteria:
    1. Subject with ulcerative colitis or indeterminate colitis. 2. 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. 3. Subject with an ostomy or ileoanal pouch. 4. Subject who has short bowel syndrome. 5. Subject with symptomatic known obstructive strictures. 6. Subject with an internal or external fistula (with the exception of an anal fistula without abscess). 7. Chronic recurring infections or active TB.

    Protocol Summary

    The purpose of this study is to investigate the efficacy, safety, and pharmacokinetics of adalimumab following subcutaneous (SC) administration of 2 dosing regimens in Chinese subjects with Crohn's disease.

    Study Locations

    No locations found.