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

Recruiting now · Phase 4

Conditions studied: Ulcerative Colitis

In brief

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®).

Key facts

Study ID

NCT04183608

Run by

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

People needed

238

Starts

2020-01-14

Expected to finish

2028-05-01

Last updated by the study team

2023-05-31

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 is running

• APHP - Hôpital du Kremlin-Bicêtre — Le Kremlin-Bicêtre, Île-de-France Region, France (enrolling)
• CHU Amiens- Picardie (site Sud) — Amiens, France (enrolling)
• CHU Nantes - Hôpital Hotel Dieu — Nantes, France (enrolling)
• CHU Nice- Hopital l'Archet — Nice, France (enrolling)
• CHU Nîmes - Hôpital Universitaire Caremeau — Nîmes, France (enrolling)
• CHU Bordeaux - Hôpital Haut Lévêque — Pessac, France (enrolling)
• CHU Lyon Sud — Pierre-Bénite, France (enrolling)
• CHU Rennes Hôpital Pontchaillou — Rennes, France (enrolling)
• CHU Toulouse - Hôpital Rangueil — Toulouse, France (enrolling)
• CHU Nancy - Hôpital de Brabois — Vandœuvre-lès-Nancy, France (enrolling)
• CHU Estaing — Clermont-Ferrand, France (enrolling)
• APHP - Hôpital Beaujon — Clichy, France (enrolling)
• CHRU Lille Hôpital Claude Huriez — Lille, France (enrolling)
• APHM - Hôpital Nord — Marseille, France (enrolling)
• GHI Le Raincy-Montfermeil — Montfermeil, France (enrolling)
• CHU Montpellier - Hôpital Saint Eloi — Montpellier, France (enrolling)
• CHRU de Besançon - Hôpital Jean Minjoz — Besançon, France
• CHU Caen Hôpital Côte de Nacre — Caen, France
• CH Saint Etienne Hopital Nord — Saint-Priest-en-Jarez, France
• CH Toulon - CHITS CH Sainte Musse — Toulon, France
• CH Colmar - Hôpital Pasteur — Colmar, France
• Centre hospitalier de Douai — Douai, France
• Centre hospitalier de Cholet — Cholet, Maine Et Loire, France
• CH Tourcoing - Hôpital Gustave Dron — Tourcoing, France

Full record on ClinicalTrials.gov

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