Comparing standard care with targeted treatment and monitoring for ulcerative colitis patients starting adalimumab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a targeted treatment approach combined with telemonitoring and patient education against standard care in adults with moderate to severe ulcerative colitis initiating adalimumab therapy. The study involves a randomized, open-label design across multiple centers in France, enrolling 238 patients. Participants will receive adalimumab and may have their treatment optimized based on their response, with follow-up assessments including endoscopic and clinical remission rates at 48 weeks. The trial aims to determine if enhanced monitoring and education can improve patient outcomes compared to standard treatment.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Amiens- Picardie (site Sud)
  Amiens, France Recruiting
• CHU Estaing
  Clermont-Ferrand, France Recruiting
• APHP - Hôpital Beaujon
  Clichy, France Recruiting
• CHRU Lille Hôpital Claude Huriez
  Lille, France Recruiting
• APHM - Hôpital Nord
  Marseille, France Recruiting
• GHI Le Raincy-Montfermeil
  Montfermeil, France Recruiting

Study contacts

• Study coordinator: Xavier Hebuterne, MD PhD
• Email: hebuterne.x@chu-nice.fr
• Phone: 04 92 03 65 75

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.