Patient with active ulcerative colitis who failed to anti-TNF with endoscopic active disease with an endoscopic Mayo score> 1 and 2 biopsies of the inflammatory tissue and presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856 MedDRA version: 20.1 Level: LLT Classification code 10058881 Term: Cytomegaloviru
Conditions
Interventions
Trade Name: valganciclovir
Product Name: valganciclovir
Pharmaceutical Form: Coated tablet
Trade Name: vedolizumab
Product Name: vedolizumab
Pharmaceutical Form: Powder for suspension for injection
Sponsors
CHU de Saint Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient with active UC - Patient with active ulcerative colitis who failed to anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure). - Patient with endoscopic active disease with an endoscopic Mayo score> 2 and 2 biopsies of the inflammatory tissue. - Presence of a CMV infection in the inflammatory tissue objectified by a viral load greater than 5 IU / 100000 cells by qPCR. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Patient with severe acute colitis - Patient treated by ciclosporin or Prograf. - HIV+ - Clostridium difficile infection. - CMV positive viremia (strongly recommending the use of an anti-CMV in the recommendations of GETAID). Insofar as the patients included will be in thrust with CMV colic, it is licit to make a blood viremia - Patient with intolerance or contraindication to the treatment used - Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of a therapeutic strategy of co-administration of vedolizumab and antiviral in terms of clinical responses to week 6 in relapsing patients with active UC, anti-TNF failure and CMV positive.;Secondary Objective: - Compare the two treatment groups (co-prescribing antiviral vs. no antiviral), in relapsing patients with active UC, anti-TNF failure and CMV positive : - clinical remission rates at week 6, - mucosal healing rates at week 6, - CMV viral load (qPCR in inflammatory tissue) at week 6 - clinical remission rates at week 52 - the colectomy rate at week 52 - Evaluate tolerance to antiviral therapy in co-administration with vedolizumab in relapsing patients with active UC, anti-TNF failure and CMV positive.;Primary end point(s): Percentage of patients in clinical response to week 6 in the arm with antiviral versus the arm without antiviral ;Timepoint(s) of evaluation of this end point: week 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Clinical remission at week 6 - Clinical remission at week 52 - Viral load in tissue at week 6 - Mucosal healing at week 6 - Adverse effects in both arms - Rate of colectomy at week 52 ;Timepoint(s) of evaluation of this end point: week 6 and week 52 | — |
Countries
France
Contacts
Public Contactproject manager
CHU de Saint Etienne
Outcome results
None listed