Tests home monitoring and patient education with adalimumab for ulcerative colitis

Trial details

Who runs it

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Trial code

NCT04183608EU 2023-507256-76-00

Record updated

31 May 2023

Original description

PHASE: IVRead full original descriptionShow less

An Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL Trial

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®).

Inclusion: 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: 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 using a prohibited medication; History of colectomy; History of colonic mucosal dysplasia or adenomatous colonic polyps that are not removed; Patients with a dominant arm deficiency or physical impairment impeding the achievement of the tests; 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; Screening stool trial positive for enteric pathogens or Clostridium difficile toxin; Patients participating in another trial or being in a follow-up period for another trial.

ClinicalTrials.gov NCT04183608 · EU CTIS 2023-507256-76-00