Ulcerative Colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: HUMIRA
Pharmaceutical Form: Injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Sponsors
GETAID
Eligibility
Sex/Gender
All
Inclusion 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) or methotrexate or adults with moderately-to-severely active UC who had no response to an adequate steroid course - Age = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 238
Exclusion criteria
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, including anti-integrin antibodies (approved or investigational), 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: o Active infection. o Non-treated latent tuberculosis. o Heart failure (NYHA: Grade III and IV). o Malignancy during the previous 5 years. o Demyelinating neurological disease. o 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 |
|---|---|
| Main Objective: 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®). ;Secondary Objective: 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 •Disability score evolution •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;Primary end point(s): 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 W48. Definition of treatment success: Endoscopic remission defined by an endoscopic Mayo score 0 ;Timepoint(s) of evaluation of this end point: Week 48 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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 0 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;Timepoint(s) of evaluation of this end point: Week 48 | — |
Countries
France
Contacts
Public ContactProject Manager
GETAID
Outcome results
None listed