Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- \- Subject successfully enrolled in and completed Study M14-115 (NCT02185014), including the Week 12 ileocolonoscopy.
Exclusion
- 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.
Key Trial Info
Start Date :
August 12 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2017
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT02185014
Start Date
August 12 2014
End Date
November 3 2017
Last Update
November 14 2018
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