Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis

Study Identifier
M11-290
CT.gov Identifier
NCT02065557
EudraCT Identifier
2013-003032-77
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Protocol
Available Language(s): English
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Statistical Analysis Plan
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Plain Language Summary
Available Language(s): English, Dutch (Belgium), Japanese, Polish, Slovak, Spanish
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Scientific Result Summary
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • Adalimumab
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    4 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of UC for at least 12 weeks prior to screening, confirmed by endoscopy with biopsy. * Active ulcerative colitis with a Mayo Score of 6 - 12 points and endoscopy subscore of 2 - 3 despite concurrent treatment with oral corticosteroids or immunosuppressants or both.
    Exclusion Criteria:
    * Subject with Crohn's disease (CD) or indeterminate colitis (IC). * Current diagnosis of fulminant colitis and/or toxic megacolon. * Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy. * Chronic recurring infections or active tuberculosis (TB).

    Protocol Summary

    The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).

    Study Locations

    Location
    Status
    Location
    Childrens Hospital LA /ID# 147452
    Los Angeles, California, United States, 90027
    Status
    Not applicable
    Location
    Univ California, San Francisco /ID# 120901
    San Francisco, California, United States, 94143-2204
    Status
    Not applicable
    Location
    Arnold Palmer Hosp Children /ID# 120898
    Orlando, Florida, United States, 32806
    Status
    Not applicable
    Location
    Emory University Hospital /ID# 121858
    Atlanta, Georgia, United States, 30322
    Status
    Not applicable
    Location
    Children's Ctr Digestive, US /ID# 121855
    Atlanta, Georgia, United States, 30342
    Status
    Not applicable
    Location
    University of Chicago /ID# 120904
    Chicago, Illinois, United States, 60637-1443
    Status
    Not applicable
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