Assessing Effectiveness of Adalimumab for Treating Ulcera... | NCT02738125 | Trialant

Assessing Effectiveness of Adalimumab for Treating Ulcera... | NCT02738125 | Trialant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to loss of clinical benefit	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.	Up to Month 120

Secondary Outcomes

Measure	Description	Time Frame
Change from Baseline (Month 0) in Steroid-free remission	Steroid- free remission is defined as partial Mayo score <= 2 with no subscore >1 and no daily intake of prednisone.	From Month 0 to Month 120
Change from Baseline (Month 0) in Clinical Remission

Contacts/Locations Module

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases