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

Study Identifier
M10-223
CT.gov Identifier
NCT00573794
EudraCT Identifier
2007-004157-28
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
  • Ulcerative Colitis (UC)
    • Study Drug
  • adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18+ years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    * Subject must have successfully enrolled and completed either study M06-826 (NCT00385736) or study M06-827 (NCT00408629) * Subject is judged to be in generally good health as determined by the principal investigator
    Exclusion Criteria:
    * Subject has not responded to weekly adalimumab therapy in M06-826 (NCT00385736) or M06-827 (NCT00408629) * Subject considered by the investigator, for any reason, to be an unsuitable candidate * Female subject who is pregnant or breast-feeding or considering becoming pregnant

    Protocol Summary

    To assess the long-term safety and maintenance of response of adalimumab in subjects with ulcerative colitis who participated in and successfully completed M06-826 (NCT00385736) or M06-827 (NCT00408629).

    Study Locations

    No locations found.