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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: ClinicalTrials.gov
Last refreshed on: 18 January 2021
Main ID:  NCT03679546
Date of registration: 18/09/2018
Prospective Registration: Yes
Primary sponsor: Rennes University Hospital
Public title: EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis EFFICACI
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
Date of first enrolment: January 4, 2019
Target sample size: 150
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03679546
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).  
Phase:  Phase 4
Countries of recruitment
France
Contacts
Name:     Guillaume BOUGUEN, MD
Address: 
Telephone: 0299284321
Email: guillaume.bouguen@chu-rennes.fr
Affiliation: 
Name:     Guillaume BOUGUEN, MD
Address: 
Telephone:
Email:
Affiliation:  Rennes University Hospital
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 Janus kinase inhibitor (JAK inhibitor) ;

- Affiliation to the national health insurance.

Non inclusion 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: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ulcerative Colitis
Intervention(s)
Drug: Infliximab
Drug: Vedolizumab Injection
Primary Outcome(s)
Remission [Time Frame: Week 14]
Secondary Outcome(s)
Adverse events [Time Frame: through study completion, an average of 1 year]
anti-drug antibodies concentration [Time Frame: baseline]
Blood trough concentration of infliximab or vedolizumab [Time Frame: at baseline, weeks 0, 2, 6, 14 and 54]
Colectomy or hospitalization for disease flare [Time Frame: through study completion, an average of 1 year]
Endoscopic subscore of the mayo Score [Time Frame: at week 14 and 54]
Faecal calprotectin level [Time Frame: At week 14 and 54]
Fecal trough concentration of infliximab or vedolizumab [Time Frame: at baseline, weeks 0, 2, 6, 14 and 54]
Inflammatory Bowel Disease Questionnaire (IBDQ) index [Time Frame: at baseline week 14 and 54]
Inflammatory Bowel Disease-Disability Index (IBD-DI) [Time Frame: at baseline week 14 and 54]
Inflammatory Bowel Disease-Disk (IBD-Disk) [Time Frame: at baseline week 14 and 54]
Last trough concentration of the first subcutaneous agent [Time Frame: baseline]
Mayo score [Time Frame: Week 54]
Partial Mayo score [Time Frame: at week 2, 6, 14, 54]
Secondary ID(s)
2018-002673-21
2018-66-PP
35RC17_8841_EFFICACI
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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