NCT02738125CompletedNot Applicable
Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions
AbbVie80 sites in 1 country265 target enrollmentStarted: April 29, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 265
- Locations
- 80
- Primary Endpoint
- Time to loss of clinical benefit
Study Overview
Brief Summary
This study assesses the long?term effectiveness of adalimumab in subjects starting a treatment for ulcerative colitis in real life conditions, namely to describe the time to loss of clinical benefit in a time to event approach.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Suffering from ulcerative colitis
- •Naïve from Adalimumab
- •Starting a treatment with adalimumab
- •Capable of and willing to grant authorization for use/disclosure of data collected
- •Able to read, understand, and complete patients questionnaires
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Time to loss of clinical benefit
Time Frame: Up to Month 120
Loss of clinical benefit will be defined as one of the following: loss of efficacy leading to adalimumab discontinuation or introduction/reinforcement of aminosalicylates, 6-mercaptopurine, or azathioprine, introduction or reinforcement of corticosteroids (any route), UC-related surgery, discontinuation of adalimumab due to adverse event, death.
Secondary Outcomes
- Change from Baseline (Month 0) in Steroid-free remission(From Month 0 to Month 120)
- Change from Baseline (Month 0) in Clinical Remission(From Month 0 to Month 120)
- Change from Baseline (Month 0) in Clinical Response(From Month 0 to Month 120)
Investigators
Study Sites (80)
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