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

Phase 1

Conditions: lcerative colitis
MedDRA version: 20.0Level: PTClassification code: 10009900Term: Colitis ulcerative Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2023-507256-76-00

Lead Sponsor: Groupe D'etude Therapeutique Des Affections Inflammatoires Du Tube Digestif

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 238

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, A contraceptive method during the whole trial for childbearing potential female, Patient familiar with Smartphone and internet use, 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), Adults with 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.

Exclusion Criteria

People unable to give their consent (because of their physical or mental state)., Contraindication to anti-TNF therapy including: 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, 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.