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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 10 October 2018
Main ID:  EUCTR2018-002673-21-FR
Date of registration: 06/07/2018
Prospective Registration: Yes
Primary sponsor: Centre Hospitalier Universitaire de Rennes
Public title: EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial.
Scientific title: EFFICACI : EFFicacy of intravenous Infliximab versus vedolizumab after failure of subCutaneous Anti-TNF in patients with UlCerative colitis : A double blinded Randomized Clinical Trial. - EFFICACI
Date of first enrolment: 04/09/2018
Target sample size: 150
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-002673-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
France
Contacts
Name: Diection de la Recherche    
Address:  2 rue Henri Le Guilloux 35033 Rennes cedex 9 France
Telephone: 0033299282555
Email: violaine.benoit@chu-rennes.fr
Affiliation:  Centre Hospitalier Universitaire de Rennes
Name: Diection de la Recherche    
Address:  2 rue Henri Le Guilloux 35033 Rennes cedex 9 France
Telephone: 0033299282555
Email: violaine.benoit@chu-rennes.fr
Affiliation:  Centre Hospitalier Universitaire de Rennes
Key inclusion & exclusion 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:
? 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]
Ulcerative colitis
MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856
Intervention(s)

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)/kilogram
Concentration type: equal
Concentration number: 5-

Trade Name: Inflectra
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)/kilogram
Concentration type: equal
Concentration number: 5-

Trade Name: Flixabi
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)/kilogram
Concentration type: equal
Concentration number: 5-

Trade Name: Remsima
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)/kilogram
Concentration type: equal
Concentration number: 5-

Trade Name: Entyvio
Product Name: Vedolizumab
Pharmaceutical Form: Powder for solution for infusion
CAS Number: 943609-66-3
Other descriptive name: VEDOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 300-

Primary Outcome(s)
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.
Primary end point(s): The rate of patients with clinical and endoscopic steroid free-remission (Mayo score = 2 without subscore > 1) 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
Timepoint(s) of evaluation of this end point: week 14
Secondary Outcome(s)
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
Secondary ID(s)
35RC17_8841_EFFICACI
Source(s) of Monetary Support
PHRC National 2017
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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