A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
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
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
238 participants
Jan 14, 2020
INTERVENTIONAL
Conditions
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®).
Eligibility
Inclusion Criteria11
- 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 Criteria19
- 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
Interventions
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
Fecal calprotectin dosing at home with IBDoc
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
Patient Education at W0, W2, W14, W26 and W38.
Locations(24)
View Full Details on ClinicalTrials.gov
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NCT04183608