Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions (SOTHIS)
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|ClinicalTrials.gov Identifier: NCT02738125|
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 22, 2018
|Condition or disease|
|Ulcerative Colitis (UC)|
|Study Type :||Observational|
|Estimated Enrollment :||540 participants|
|Official Title:||Assessing Effectiveness of Adalimumab for Treating Ulcerative Colitis in Real Life Conditions|
|Actual Study Start Date :||April 29, 2016|
|Estimated Primary Completion Date :||November 20, 2028|
|Estimated Study Completion Date :||November 20, 2028|
Subjects starting/ receiving adalimumab
Subjects starting/ receiving Adalimumab for UC
- 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.
- Change from Baseline (Month 0) in Steroid-free remission [ Time Frame: From Month 0 to Month 120 ]Steroid- free remission is defined as partial Mayo score <= 2 with no subscore >1 and no daily intake of prednisone.
- Change from Baseline (Month 0) in Clinical Remission [ Time Frame: From Month 0 to Month 120 ]Clinical remission is defined as partial Mayo score <= 2 with no subscore >1
- Change from Baseline (Month 0) in Clinical Response [ Time Frame: From Month 0 to Month 120 ]Clinical response is decrease in partial Mayo score >= 3 points and >= 30% from baseline plus a decrease in rectal bleeding subscore >= 1 or an absolute rectal bleeding subscore <= 1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738125
|Contact: Romain Fardellonefirstname.lastname@example.org|
|Contact: Yohann Gorrichonemail@example.com|
Show 81 Study Locations
|Study Director:||AbbVie Inc.||AbbVie|