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

Inclusion Criteria:

• Adults with moderately-to-severely active Ulcerative Colitis (UC) who had aninadequate response to or failed to tolerate steroids and thiopurines (azathioprine or 6-mercaptopurine), methotrexate or vedolizumab or adults with moderately-to-severelyactive 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 (approvedor 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 6-12points (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 doseif no contra-indication.
• Azathioprine, 6-mercaptopurine or methotrexate will be stopped two weeks beforeinclusion.
• 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 notremoved.
• Screening stool trial positive for enteric pathogens or Clostridium difficile toxin.
• Oral corticosteroids at a dose > 40 mg prednisone or its equivalent per day atinclusion (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 otherbiologics (except vedolizumab), JAK inhibitors (approved or investigational), or anycurrent or previous use of an investigational agent within 5 half-lives of that agentbefore 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 theachievement of the tests
• Patients using a prohibited medication
• Patients participating in another trial or being in a follow-up period for anothertrial