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

  • STATUS
    Recruiting
  • End date
    May 10, 2024
  • participants needed
    238
  • sponsor
    Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Updated on 10 July 2021
methotrexate
endoscopy
adalimumab
tumor necrosis factor
mercaptopurine
azathioprine
proctitis
mesalamine
thiopurines
faecal calprotectin
janus kinase inhibitor
anti-tnf-alpha therapy
pancolitis

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).

Description

NUMBER OF PATIENTS : 238 patients in 20 sites in France

RECRUITMENT PERIOD : The trial duration for each patient will be 144 weeks

MAIN ENDPOINT : At week 48 success defined by: Endoscopic remission defined by an endoscopic Mayo score 0

SECONDARY ENDPOINTS:

At W48

  • Clinical remission (Clinical remission is defined as a total Mayo score 2 points, with no individual sub score >1, and a Mayo endoscopy sub score of 0 or 1)
  • Remission without steroids
  • Endoscopic healing rate with Mayo score 0 or 1
  • UCEIS score
  • Histological healing (Nancy score)
  • Remission rate and remission rate without steroids at study visits and W48
  • Quality of life evolution (evaluate visit W0 vs W14, W26, W38 and W48)
  • Patients satisfaction
  • Continuous response
  • Safety and tolerability
  • Anti-TNF pharmacokinetics
  • Number of visits in trial
  • Number of UC related hospitalizations
  • Number of colectomies
  • Treatment compliance (questionnaire)
  • Patient adhesion (questionnaire)
  • Medico-economic analysis

Details
Condition Ulcerative Colitis, Ulcerative Colitis (Pediatric)
Treatment Adalimumab, Calprotectin, e-Monitoring, Therapy Education
Clinical Study IdentifierNCT04183608
SponsorGroupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Last Modified on10 July 2021

Eligibility

Yes No Not Sure

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