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

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

Inclusion criteria

• Adults with moderately-to-severely active Ulcerative Colitis (UC) who had an inadequate response to or failed to tolerate steroids and thiopurines (azathioprine or 6-mercaptopurine), methotrexate or vedolizumab or adults with moderately-to-severely active UC who had no response to an adequate steroid course
• Age ≥ 18 years and < 75 years
• Patients scheduled to start a treatment with adalimumab
• Naïve to anti-TNF therapy and other biologics known to be effective for UC (approved or investigational) except for vedolizumab
• Naïve to JAK inhibitors (approved or investigational)
• Moderately-to-severely active UC for at least 3 months with a Mayo score of 6-12 points (endoscopy subscore of at least 2)
• Established diagnosis of UC for at least 3 months (pancolitis, left-sided colitis, proctosigmoiditis and proctitis are allowed).
• Patient has to be treated with oral 5-ASA at time of inclusion regardless of the dose if no contra-indication.
• Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks before inclusion.
• A contraceptive method during the whole trial for childbearing potential female
• Patient familiar with Smartphone and internet use

Exclusion criteria

• Patients unable to give their consent (because of their physical or mental state).
• Absence of written consent.
• Pregnancy or breastfeeding.
• Patients with severe acute colitis or patients at imminent risk for colectomy.
• History of colectomy.
• History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed.
• Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.
• Oral corticosteroids at a dose > 40 mg prednisone or its equivalent per day at inclusion (oral steroids should be at stable dose at least 7 days before inclusion)
• Any current or previous use of cyclosporine, tacrolimus, anti-TNF therapy, and other biologics (except vedolizumab), JAK inhibitors (approved or investigational), or any current or previous use of an investigational agent within 5 half-lives of that agent before the first trial agent injection.
• Contraindication to anti-TNF therapy according to drug labeling:

• Active infection.
• Non-treated latent tuberculosis.
• Heart failure (NYHA: Grade III and IV).
• Malignancy during the previous 5 years.
• Demyelinating neurological disease.
• Current or recent (less than 4 weeks) vaccination with attenuated live vaccines
• Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests
• Patients using a prohibited medication
• Patients participating in another trial or being in a follow-up period for another trial