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

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

Status and phase: Enrolling; Phase 4

Conditions: Ulcerative Colitis

Treatments: Other: Therapy Education; Drug: Adalimumab; Other: e-Monitoring; Diagnostic Test: Calprotectin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04183608

GETAID-2018-01

Details and patient eligibility

About

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®).

Full 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

Enrollment: 238 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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238 participants in 2 patient groups

Group Standard of care

Active Comparator group

Description:

In standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency.

Treatment:

Drug: Adalimumab

Groupe T2T with telemonitoring and patient education

Active Comparator group

Description:

Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.

Treatment:

Other: e-Monitoring

Other: Therapy Education

Drug: Adalimumab

Diagnostic Test: Calprotectin