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®).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
238
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
Fecal calprotectin dosing at home with IBDoc
e-Monitoring at Week 6, Week 10, Week 14, Week 18, Week 22, Week 26, Week 34, Week 38, Week 42 and Week 48 The patient must complete the first 2 questions of the Mayo score: * Stool frequency * The frequency of bleeding He must also complete the information on his injections
Patient Education at W0, W2, W14, W26 and W38.
Centre hospitalier de Cholet
Cholet, Maine Et Loire, France
ACTIVE_NOT_RECRUITINGCHU Amiens- Picardie (site Sud)
Amiens, France
RECRUITINGCHRU de Besançon - Hôpital Jean Minjoz
Besançon, France
ACTIVE_NOT_RECRUITINGCHU Caen Hôpital Côte de Nacre
Caen, France
WITHDRAWNCHU Estaing
Clermont-Ferrand, France
RECRUITINGAPHP - Hôpital Beaujon
Clichy, France
RECRUITINGCH Colmar - Hôpital Pasteur
Colmar, France
ACTIVE_NOT_RECRUITINGCentre hospitalier de Douai
Douai, France
TERMINATEDCHRU Lille Hôpital Claude Huriez
Lille, France
RECRUITINGAPHM - Hôpital Nord
Marseille, France
RECRUITING...and 14 more locations
Endoscopic Remission
Treatment success of a treat to target with telemonitoring follow up using e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education compared to standard treatment follow up at Week 48. Definition of treatment success: Endoscopic remission defined by an endoscopic Mayo score 0
Time frame: Week 48
Efficacy of adalimumab treatment on clinical remission (at Week 48)
* Remission without steroids: * Remission rate and remission rate without steroids at study visits and Week 48
Time frame: Week 48
Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)
Endoscopic healing rate with Mayo score 0 or 1
Time frame: Week 48
Efficacy of adalimumab treatment on endoscopic mucosal healing
UCEIS score
Time frame: Week 48
Efficacy of adalimumab treatment on histological Healing (at Week 48)
Histological healing (Nancy index)
Time frame: Week 48
Efficacy of adalimumab treatment on patient quality of life (at Week 48)
Quality of life evolution (evaluate visit 0 vs -Week 14, Week 26, Week 38 and Week 48)
Time frame: Week 48
Patient satisfaction
Patient satisfaction evaluate with all questionnaires of quality of life
Time frame: Week 48
Treatment compliance
Treatment compliance evaluate at every visit
Time frame: Week 48
Patient adhesion
Patient adhesion evaluate with questionnaire
Time frame: Week 48
Disability score evolution
IBD Disability index, evaluate visit 0 vs - Week 14, Week 26, Week 38 and Week 48
Time frame: Week 48
Medico-economic analysis
Medico-economic comparative analysis between standard of care follow up and tight monitoring follow up
Time frame: Week 48
Continuous Clinical Response (CCR)
Definition: Partial Mayo Response at each visit (Visit 1, Visit 2, Visit 3) with a total Mayo response on Week 48 Visit 4 visit. In the telemonitoring group the partial Mayo limited to questions 1 and 2 will be directly answered by patients themselves through ePRO2 they will score the first 2 questions of partial Mayo from home and send that info to the investigator.
Time frame: Week 48
Loss of clinical response
Pharmacokinetic dosage of Adalimumab (Anti-TNF)
Time frame: Week 48
Number of visits in trial
Number of visits in trial per patients
Time frame: Week 48
Colectomies at Week 48
Proportion of patients with colectomy
Time frame: Week 48
UC related Hospitalizations at Week 48
Proportion of UC related hospitalizations
Time frame: Week 48
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