Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Study Identifier
M14-033
CT.gov Identifier
NCT02065622
EudraCT Identifier
2013-001682-16
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

Results Available

Statistical Analysis Plan
Available Language(s): English
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Protocol
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Plain Language Summary
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Scientific Result Summary
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period. * Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both. Mayo Score is confirmed by central reader.
    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

    To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.

    Study Locations

    Location
    Status
    Location
    Digestive Health Specialists of the Southeast /ID# 127844
    Dothan, Alabama, United States, 36305
    Status
    Not applicable
    Location
    Ucsd /Id# 122313
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Rocky Mountain Clinical Resear /ID# 122180
    Wheat Ridge, Colorado, United States, 80033
    Status
    Not applicable
    Location
    Medical Research Ctr CT /ID# 122179
    Hamden, Connecticut, United States, 06518
    Status
    Not applicable
    Location
    Gastro Florida /ID# 170619
    Clearwater, Florida, United States, 33756
    Status
    Not applicable
    Location
    Research Associates of South Florida,LLC /ID# 170309
    Miami, Florida, United States, 33156
    Status
    Not applicable
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