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

Official title

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

Overview

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®).

Detailed 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

Interventions

• Drug Adalimumab
  Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
• Diagnostic test Calprotectin
  Fecal calprotectin dosing at home with IBDoc
• Other e-Monitoring
  e-Monitoring at Week 6, Week 10, Week 14, Week 18, Week 22, Week 26, Week 34, Week 38, Week 42 and Week 48 The patient must complete the first 2 questions of the Mayo score: * Stool frequency * The frequency of bleeding He must also complete the information on his injections
• Other Therapy Education
  Patient Education at W0, W2, W14, W26 and W38.

Primary outcome measures

• Endoscopic Remission [Time frame: Week 48]

Secondary outcome measures (12)

• Efficacy of adalimumab treatment on clinical remission (at Week 48) [Time frame: Week 48]
• Efficacy of adalimumab treatment on endoscopic Healing (at Week 48) [Time frame: Week 48]
• Efficacy of adalimumab treatment on endoscopic mucosal healing [Time frame: Week 48]
• Efficacy of adalimumab treatment on histological Healing (at Week 48) [Time frame: Week 48]
• Efficacy of adalimumab treatment on patient quality of life (at Week 48) [Time frame: Week 48]
• Patient satisfaction [Time frame: Week 48]
• Treatment compliance [Time frame: Week 48]
• Patient adhesion [Time frame: Week 48]
• Disability score evolution [Time frame: Week 48]
• Medico-economic analysis [Time frame: Week 48]
• Continuous Clinical Response (CCR) [Time frame: Week 48]
• Loss of clinical response [Time frame: Week 48]

Eligibility 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), 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 24 centers

• Centre hospitalier de Cholet — Cholet
• CHU Amiens- Picardie (site Sud) — Amiens
• CHRU de Besançon - Hôpital Jean Minjoz — Besançon
• CHU Caen Hôpital Côte de Nacre — Caen
• CHU Estaing — Clermont-Ferrand
• APHP - Hôpital Beaujon — Clichy
• CH Colmar - Hôpital Pasteur — Colmar
• Centre hospitalier de Douai — Douai
• … and 16 more centers

Publications

• Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3. PMID 40243391

Identifiers

NCT: NCT04183608 · GETAID-2018-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗