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A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab — CONTROL  

Ulcerative Colitis Clinical Trial

Official title:
An Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL Trial

Clinical Trial Summary

PHASE: IV DESCRIPTIVE: Randomized, interventional, open label multicenter trial POPULATION: Moderate to severe ulcerative colitis STUDY TREATMENTS: Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) and could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38). OBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).

Clinical Trial 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 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04183608
Study type Interventional
Source Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Contact Xavier Hebuterne, MD PhD
Phone 04 92 03 65 75
Email hebuterne.x@chu-nice.fr
Status Recruiting
Phase Phase 4
Start date January 14, 2020
Completion date May 2028
View Details
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