Ulcerative Colitis (UC) is an inflammatory bowel disease that can require the use of anti-TNF alpha therapy. When anti-TNF alpha failed to obtain a clinical response, the use of a new anti-integrin therapy, vedolizumab, can be proposed. The efficacy of vedolizumab has been assessed in a phase 3 study (GEMINI I), with response rates of 41.1% with vedolizumab vs 25.5% with placebo. CytoMegaloVirus (CMV) reactivation has been associated with resistance to steroid and to several lines of immunosuppressive therapy. Antiviral therapy was proven to decrease the tissue viral load and to restore the response to immunosuppressive therapies (up to 80% in small group of patients). A recent meta-analysis supports the use of valganciclovir in case of CytoMegaloVirus (CMV) reactivation in active Ulcerative Colitis (UC). Moreover, a study showed that the risk of CMV reactivation seems to be more important with vedolizumab than with anti TNF, and the risk of colectomy is higher in case of CytoMegaloVirus (CMV) reactivation (p\<0.05).
The hypothesis of this study is in Ulcerative Colitis (UC) patients with tissue CytoMegaloVirus (CMV) reactivation ; not responding to anti-TNF or without anti-TNF ; a treatment with valganciclovir, added to vedolizumab, could improve the clinical response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks
CH d'Annecy
Annecy, France
CHU de Clermont-Ferrand
Clermont-Ferrand, France
CHU de Lyon Sud
Lyon, France
CHU de Montpellier
Montpellier, France
CHU de Nice
Nice, France
APHP - Hôpital Saint-Antoine
Paris, France
CHU ROUEN - Service Gastro-entérologie
Rouen, France
CHU de Saint Etienne
Saint-Etienne, France
Clinical response
Percentage of patients in clinical response. the clinical response is defined by the decrease in the total Mayo Score compared to the inclusion of at least 3 points and at least 30% with a decrease in the score of bleeding (item 2 of the Mayo sub-score) from at least one point or sub-score of bleeding from 0 or 1 point with or without anti-CMV treatment. The Mayo score includes 3 items: stool frequency, presence of blood in the stool, and overall assessment of the disease.
Time frame: Weeks 6
Clinical remission
Percentage of patients in clinical remission defined by a total Mayo score \<3 with an endoscopic score \<2 and no clinical sub-score\> 2.
Time frame: Weeks 6
Mucosal healing
Percentage of patients in mucosal healing defined by endoscopic mayo score \<2
Time frame: Weeks 6
Viral load CytoMegaloVirus (CMV)
Value of viral load CytoMegaloVirus (CMV) by qPCR on inflammatory tissue in IU / 100000 cells.
Time frame: Weeks 6
clinical remission
Percentage of patients in clinical remission defined by a total Mayo score \<3 with an endoscopic score \<2 and no clinical sub-score\> 2.
Time frame: Weeks 52
Rate of colectomy
Percentage of patients who required colectomy
Time frame: Weeks 52
Adverse effects
Number and severity of adverse effects
Time frame: Weeks 52
viral load of the Torque teno virus
performed on the blood tube and tissue biopsies
Time frame: Week 6
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