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
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 238
- Locations
- 24
- Primary Endpoint
- Endoscopic Remission
Study Overview
Brief 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®).
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Adalimumab (Drug)
Groupe T2T with telemonitoring and patient education
Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.
Intervention: Adalimumab (Drug)
Groupe T2T with telemonitoring and patient education
Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.
Intervention: Calprotectin (Diagnostic Test)
Groupe T2T with telemonitoring and patient education
Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.
Intervention: e-Monitoring (Other)
Groupe T2T with telemonitoring and patient education
Treatment with e-Monitoring, home fecal calprotectin testing and therapy education.
Intervention: Therapy Education (Other)
Outcomes
Primary Outcomes
Endoscopic Remission
Time Frame: Week 48
Treatment success of a treat to target with telemonitoring follow up using e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education compared to standard treatment follow up at Week 48. Definition of treatment success: Endoscopic remission defined by an endoscopic Mayo score 0
Secondary Outcomes
- UC related Hospitalizations at Week 48(Week 48)
- Efficacy of adalimumab treatment on endoscopic Healing (at Week 48)(Week 48)
- Efficacy of adalimumab treatment on histological Healing (at Week 48)(Week 48)
- Efficacy of adalimumab treatment on patient quality of life (at Week 48)(Week 48)
- Patient satisfaction(Week 48)
- Treatment compliance(Week 48)
- Patient adhesion(Week 48)
- Disability score evolution(Week 48)
- Number of visits in trial(Week 48)
- Colectomies at Week 48(Week 48)
- Efficacy of adalimumab treatment on clinical remission (at Week 48)(Week 48)
- Efficacy of adalimumab treatment on endoscopic mucosal healing(Week 48)
- Continuous Clinical Response (CCR)(Week 48)
- Loss of clinical response(Week 48)
- Medico-economic analysis(Week 48)