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

Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study ID
NCT04183608
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — DRUG
    Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
  • Calprotectin — DIAGNOSTIC_TEST
    Fecal calprotectin dosing at home with IBDoc
  • e-Monitoring — OTHER
    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
  • Therapy Education — OTHER
    Patient Education at W0, W2, W14, W26 and W38.

Study Details

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 Dates

Start date
Jan 14, 2020
Status verified
May 2023
Primary completion
Apr 30, 2025
Completion
May 31, 2028

Study Design

Enrollment
238 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Active Comparator: Group Standard of care
    In standard of care, patient only visits every 3 months the doctor so the optimization of treatment can be done only at this frequency.
  • Active Comparator: Groupe T2T with telemonitoring and patient education
    Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.

Primary Outcome Measure

Endoscopic Remission [ Time Frame: Week 48 ]

Central Contacts

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