a trial comparing standard of care versus treat to target with telemonitoring and patient education in patients with ulcerative colitis initiating adalimumab

Conditions: Ulcerative Colitis

Summary: 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

Eligibility criteria:
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

Keywords: ibd uc