Last updated on February 2020

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


Brief description of study

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).

Detailed Study 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

Clinical Study Identifier: NCT04183608

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