Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis

Study Identifier
M10-870
CT.gov Identifier
NCT02632175
EudraCT Identifier
2015-001346-29
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
Available Language(s): English
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Plain Language Summary
Available Language(s): English, Polish, Slovak, Japanese
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Scientific Result Summary
Available Language(s): English
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Study Details

Medical Condition
  • Ulcerative Colitis (UC)
    • Study Drug
  • Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    4 - 17 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Subject must have successfully enrolled and completed M11-290 study
    Exclusion Criteria:
    \- Subject considered by the investigator, for any reason, to be an unsuitable candidate

    Protocol Summary

    This study assesses the long-term safety and efficacy of adalimumab in pediatric subjects with ulcerative colitis.

    Study Locations

    Location
    Status
    Location
    Arnold Palmer Hospital /ID# 147295
    Orlando, Florida, United States, 32806
    Status
    Not applicable
    Location
    MNGI Digestive Health, P. A. /ID# 147294
    Minneapolis, Minnesota, United States, 55413-2195
    Status
    Not applicable
    Location
    Mayo Clinic - Rochester /ID# 147304
    Rochester, Minnesota, United States, 55905-0001
    Status
    Not applicable
    Location
    MultiCare Institute Health System /ID# 169005
    Tacoma, Washington, United States, 98405
    Status
    Not applicable
    Location
    Kurume University Hospital /ID# 145710
    Kurume-shi, Fukuoka, Japan, 830-0011
    Status
    Not applicable
    Location
    Juntendo University Hospital /ID# 147315
    Bunkyo-ku, Tokyo, Japan, 113-8431
    Status
    Not applicable
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