Open Label Study to Evaluate Long Term Efficacy, Safety and Tolerability of Repeated Dosing in Subjects With Crohn's Disease and Who Participated and Successfully Completed M14-115

Study Identifier
M14-347
CT.gov Identifier
NCT02185014
EudraCT Identifier
2013-004034-15
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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Scientific Result Summary
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Study Details

Medical Condition
  • Crohn's Disease (CD)
    • Study Drug
  • Adalimumab
    • Phase
    Phase 3
    Sex
    Female & Male
    Age
    18 - 75 Years
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    \- Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the Week 12 ileocolonoscopy.
    Exclusion Criteria:
    * If the Week 12 (Study M14-115; NCT02185014) colonoscopy shows evidence of dysplasia or malignancy. * Subject is not in compliance with prior and concomitant medication requirements throughout M14-115 (NCT02185014). * Subject who developed active Tuberculosis (TB) during M14-115 (NCT02185014), or subject who is non compliant with prophylaxis for latent tuberculosis (TB) initiated per M14-115 (NCT02185014) procedures.

    Protocol Summary

    The purpose of this study is to evaluate the long term efficacy, safety, and tolerability of repeated administration of adalimumab in participants with Crohn's disease.

    Study Locations

    No locations found.