Ulcerative Colitis
Conditions
Keywords
IBD, UC
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 * 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
DRUGAdalimumab
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
DIAGNOSTIC_TESTCalprotectin
Fecal calprotectin dosing at home with IBDoc
OTHERe-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
OTHERTherapy Education
Patient Education at W0, W2, W14, W26 and W38.
Sponsors
AbbVie
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic Remission | 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
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of adalimumab treatment on endoscopic Healing (at Week 48) | Week 48 | Endoscopic healing rate with Mayo score 0 or 1 |
| Efficacy of adalimumab treatment on endoscopic mucosal healing | Week 48 | UCEIS score |
| Efficacy of adalimumab treatment on histological Healing (at Week 48) | Week 48 | Histological healing (Nancy index) |
| Efficacy of adalimumab treatment on patient quality of life (at Week 48) | Week 48 | Quality of life evolution (evaluate visit 0 vs -Week 14, Week 26, Week 38 and Week 48) |
| Patient satisfaction | Week 48 | Patient satisfaction evaluate with all questionnaires of quality of life |
| Treatment compliance | Week 48 | Treatment compliance evaluate at every visit |
| Patient adhesion | Week 48 | Patient adhesion evaluate with questionnaire |
| Efficacy of adalimumab treatment on clinical remission (at Week 48) | Week 48 | * Remission without steroids: * Remission rate and remission rate without steroids at study visits and Week 48 |
| Medico-economic analysis | Week 48 | Medico-economic comparative analysis between standard of care follow up and tight monitoring follow up |
| Continuous Clinical Response (CCR) | Week 48 | Definition: Partial Mayo Response at each visit (Visit 1, Visit 2, Visit 3) with a total Mayo response on Week 48 Visit 4 visit. In the telemonitoring group the partial Mayo limited to questions 1 and 2 will be directly answered by patients themselves through ePRO2 they will score the first 2 questions of partial Mayo from home and send that info to the investigator. |
| Loss of clinical response | Week 48 | Pharmacokinetic dosage of Adalimumab (Anti-TNF) |
| Number of visits in trial | Week 48 | Number of visits in trial per patients |
| Colectomies at Week 48 | Week 48 | Proportion of patients with colectomy |
| UC related Hospitalizations at Week 48 | Week 48 | Proportion of UC related hospitalizations |
| Disability score evolution | Week 48 | IBD Disability index, evaluate visit 0 vs - Week 14, Week 26, Week 38 and Week 48 |
Countries
France
Contacts
Primary ContactXavier Hebuterne, MD PhD
Outcome results
None listed