A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Ulcerative Colitis
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
NUMBER OF PATIENTS : 238 patients in 20 sites in France RECRUITMENT PERIOD : The trial duration for each patient will be 144 weeks MAIN ENDPOINT : At week 48 success defined by: Endoscopic remission defined by an endoscopic Mayo score 0 SECONDARY ENDPOINTS: At W48 Clinical remission (Clinical remiss...
NUMBER OF PATIENTS : 238 patients in 20 sites in France RECRUITMENT PERIOD : The trial duration for each patient will be 144 weeks MAIN ENDPOINT : At week 48 success defined by: Endoscopic remission defined by an endoscopic Mayo score 0 SECONDARY ENDPOINTS: At W48 Clinical remission (Clinical remission is defined as a total Mayo score ?2 points, with no individual sub score >1, and a Mayo endoscopy sub score of 0 or 1) Remission without steroids Endoscopic healing rate with Mayo score 0 or 1 UCEIS score Histological healing (Nancy score) Remission rate and remission rate without steroids at study visits and W48 Quality of life evolution (evaluate visit W0 vs W14, W26, W38 and W48) Patients satisfaction Continuous response Safety and tolerability Anti-TNF pharmacokinetics Number of visits in trial Number of UC related hospitalizations Number of colectomies Treatment compliance (questionnaire) Patient adhesion (questionnaire) Medico-economic analysis
Tracking Information
- NCT #
- NCT04183608
- Collaborators
- AbbVie
- Investigators
- Not Provided
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