Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

Study Identifier
M14-115
CT.gov Identifier
NCT02065570
EudraCT Identifier
2013-001746-33
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, Czech, Dutch, Hebrew, Polish, Ukrainian
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Scientific Result Summary
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
  • Adalimumab
  • Placebo
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period. * Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants. * Mucosal ulceration on endoscopy.
    Exclusion Criteria:
    * Subject with ulcerative colitis or indeterminate colitis. * Subject who has had surgical bowel resections in the past 6 months or is planning resection. * Subjects with an ostomy or ileoanal pouch. * Subject with symptomatic bowel stricture or abdominal or peri-anal abcess. * Subject who has short bowel syndrome. * Chronic recurring infections or active Tuberculosis (TB).

    Protocol Summary

    This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

    Study Locations

    Location
    Status
    Location
    Birmingham Gastroenterology Associates O.C /ID# 137282
    Birmingham, Alabama, United States, 35209
    Status
    Not applicable
    Location
    Digestive Health Specialists of the Southeast /ID# 122483
    Dothan, Alabama, United States, 36305
    Status
    Not applicable
    Location
    Moore UC San Diego Cancer Center /ID# 119053
    La Jolla, California, United States, 92093
    Status
    Not applicable
    Location
    Axis Clinical Trials /ID# 130390
    Los Angeles, California, United States, 90036
    Status
    Not applicable
    Location
    Rocky Mountain Gastroenterology /ID# 119038
    Wheat Ridge, Colorado, United States, 80033
    Status
    Not applicable
    Location
    Medical Research Ctr CT /ID# 119037
    Hamden, Connecticut, United States, 06518
    Status
    Not applicable
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