Ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Conditions
Interventions
Trade Name: Remicade
Product Name: infliximab
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: mg/kg milligram(s)/kilog
Sponsors
Centre Hospitalier Universitaire de Rennes
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Male or non-pregnant female, non-lactating female; ? 18 years of age or older and less than 75 years ; ? Documented diagnosis of UC for at least 6 months ; ? Left side colitis or pancolitis ; ? Moderate to severe disease according to a Mayo score equal or above 6 with a Mayo endoscopic sub-score of 2 or 3 ; ? Active disease despite ongoing treatment with adalimumab or golimumab for at least 12 weeks (inadequate response, failure, loss of response or intolerance) ; ? Ability of the subject to participate fully in all aspects of this clinical trial ; ? Written informed consent must be obtained and documented ; ? Naïve to JAK inhibitor ; ? Affiliation to the national health insurance. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: ? Contraindication to continue TNF antagonist (ongoing abscess(es), clinical suspicion of tuberculosis, past allergic reaction) ; ? Contraindication to vedolizumab treatment ; ? Steroid treatment > 20 mg/day for at least two weeks before baseline ; ? Proctitis ; ? Stoma ; ? Proctocolectomy or subtotal colectomy ; ? Planned surgery within the year of the trial ; ? Previous exposure to vedolizumab or infliximab ; ? History of cancer during the past 5 years ; ? Pregnancy or breastfeeding ? Adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty. ? Ongoing participation to another interventional study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether a non-TNF-targeted biologic (vedolizumab) is superior to infliximab to treat patient with UC losing response or with a primary failure to a first subcutaneous anti-TNF drug at week 14.;Secondary Objective: ?To assess the rate of clinical response and remission at Week 54 in each group of treatments and the time to clinical response and remission from baseline ; ?To assess the changes in faecal calprotectin levels from baseline to week 14 and 54 according to treatment ; ?To assess the rate of colectomy and hospitalization in each treatment group ; ?To assess the rate of mucosal healing at week 14 and 54 in each group of treatments ; To assess the rate of loss of response To assess the changes of quality of life indexes and the disability index To determine the safety profile To characterize the response according to drug monitoring of the first anti-TNF agent To describe the pharmacokinetics of infliximab and vedolizumab and explore the sources of pharmacokinetic inter-individual variability To identify predictive factors of response to the treatment, including pharmacokinetic features ;Primary end point(s): The rate of patients with clinical and endoscopic steroid free-remission (Mayo score = 2 without subscore > 1) at week 14.;Timepoint(s) of evaluation of this end point: week 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Mayo score at week 54 ; ? Faecal calprotectine level at week 14 and 54 ; ? Colectomy or hospitalization for disease flare during the study period ; ? Endoscopic subscore of the mayo Score at week 14 and 54 ; ? Partial Mayo score at week 2, 6, 14, 54 ; ? IBDQ index, IBD-Disk and IBD-DI at baseline week 14 and 54 ? Rate and type of adverse events during the study period ; ? Last trough concentration of the first subcutaneous agent at the time of the loss of response and anti-drug antibodies concentration ; ? Trough concentration of infliximab or vedolizumab at each visit and anti-drug antibodies concentration.;Timepoint(s) of evaluation of this end point: week 2, 6, 14 and 54 | — |
Countries
France
Contacts
Public ContactDiection de la Recherche
Centre Hospitalier Universitaire de Rennes
Outcome results
None listed