EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 4 December 2023
• 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/ct2/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

• Name: Guillaume BOUGUEN, MD
• 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: Vedolizumab Injection

Drug: Infliximab

Primary Outcome(s)

Remission [Time Frame: Week 14]

Secondary Outcome(s)

anti-drug antibodies concentration [Time Frame: baseline]

Endoscopic subscore of the mayo Score [Time Frame: at week 14 and 54]

Faecal calprotectin level [Time Frame: At week 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]

Colectomy or hospitalization for disease flare [Time Frame: through study completion, an average of 1 year]

Fecal trough concentration of infliximab or vedolizumab [Time Frame: at baseline, weeks 0, 2, 6, 14 and 54]

Partial Mayo score [Time Frame: at week 2, 6, 14, 54]

Blood trough concentration of infliximab or vedolizumab [Time Frame: at baseline, weeks 0, 2, 6, 14 and 54]

Adverse events [Time Frame: through study completion, an average of 1 year]

Last trough concentration of the first subcutaneous agent [Time Frame: baseline]

Mayo score [Time Frame: Week 54]

Inflammatory Bowel Disease-Disk (IBD-Disk) [Time Frame: at baseline week 14 and 54]

Secondary ID(s)

35RC17_8841_EFFICACI

2018-002673-21

2018-66-PP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors