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

RecruitingPhase 4Ages 18 Years - 75 YearsAllGroupe d'Etude Therapeutique des Affections Infla…
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In plain words

What the trial is, and whether it could suit you

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®).

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📋 Eligibility rules (as published)
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
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What it tests

  • Adalimumab
  • Calprotectin
  • e-Monitoring
  • Therapy Education
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Where

24 sites
Centre hospitalier de Cholet
Cholet, France
CHU Amiens- Picardie (site Sud)
Amiens, France
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France
CHU Caen Hôpital Côte de Nacre
Caen, France
CHU Estaing
Clermont-Ferrand, France
APHP - Hôpital Beaujon
Clichy, France
CH Colmar - Hôpital Pasteur
Colmar, France
Centre hospitalier de Douai
Douai, France

…and 16 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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