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

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: All

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®).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Collaborator: AbbVie
• Treatments: Adalimumab

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) or methotrexate 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 (i.e anti-integrin antibodies) or other biologics known to be effective for UC (approved or investigational)

• 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.

• A contraceptive method during the whole trial for childbearing potential female

• Patient familiar with Smartphone and internet use

Exclusion Criteria:

• The patients should not present any of the following criteria:

• People 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, including anti-integrin antibodies (approved or investigational), 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 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