Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy (CYTOVEDO)
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|ClinicalTrials.gov Identifier: NCT04064697|
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : September 4, 2019
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).
|Condition or disease||Intervention/treatment||Phase|
|Ulcerative Colitis, Unspecified||Drug: Valganciclovir||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Anti-cytomegalovirus (Valganciclovir) Treatment in the Management of Relapsing Ulcerative Colitis (UC) Requiring Vedolizumab Therapy: a Randomized Clinical Trial Comparing a Strategy With or Without Antiviral Therapy. CYTOVEDO Study|
|Estimated Study Start Date :||September 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2023|
No Intervention: Control group
Patient will be treated by vedolizumab the standard of care alone.
Experimental: Experimental group
Patient will be treated by vedolizumab the standard of care associated at valganciclovir.
The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks
Other Name: antiviral therapy
- Clinical response [ Time Frame: Weeks 6 ]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.
- Clinical remission [ Time Frame: Weeks 6 ]Percentage of patients in clinical remission defined by a total Mayo score <3 with an endoscopic score <2 and no clinical sub-score> 2.
- Mucosal healing [ Time Frame: Weeks 6 ]Percentage of patients in mucosal healing defined by endoscopic mayo score <2
- Viral load CytoMegaloVirus (CMV) [ Time Frame: Weeks 6 ]Value of viral load CytoMegaloVirus (CMV) by qPCR on inflammatory tissue in IU / 100000 cells.
- clinical remission [ Time Frame: Weeks 52 ]Percentage of patients in clinical remission defined by a total Mayo score <3 with an endoscopic score <2 and no clinical sub-score> 2.
- Rate of colectomy [ Time Frame: Weeks 52 ]Percentage of patients who required colectomy
- Adverse effects [ Time Frame: Weeks 52 ]Number and severity of adverse effects
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064697
|Contact: Pauline VEYRARD, MD||(0)477828619 ext +email@example.com|
|Contact: Marie PEURIERE, CRA||(0)477120826 ext +33||Marie.Peuriere@chu-st-etienne.fr|
|CH d'Annecy||Not yet recruiting|
|Principal Investigator: Frédéric Heluwaert, MD|
|Sub-Investigator: Joanna Pofelski, MD|
|CHU de Clermont-Ferrand||Not yet recruiting|
|Principal Investigator: Anthony Buisson, MD|
|CHU de Grenoble||Not yet recruiting|
|Principal Investigator: Nicolas Mathieu, MD|
|CHU de Lyon Sud||Not yet recruiting|
|Principal Investigator: Stephane Nancey, PhD|
|Sub-Investigator: Pauline Danion, MD|
|Sub-Investigator: Bernard Flourie, MD|
|Sub-Investigator: Gilles Boschetti, MD|
|CHU de Montpellier||Not yet recruiting|
|Principal Investigator: Romain Altwegg, MD|
|Sub-Investigator: Lucile Boivineau, MD|
|CHU de Nice||Not yet recruiting|
|Principal Investigator: Jérôme Filippi, MD|
|Sub-Investigator: Xavier Hebuterne, PhD|
|Sub-Investigator: Nadia Arab, MD|
|Sub-Investigator: Julie Benard, MD|
|APHP - Hôpital Saint-Antoine||Not yet recruiting|
|Principal Investigator: Harry Sokol, PhD|
|CHU de Saint Etienne||Not yet recruiting|
|Principal Investigator: Pauline VEYRARD, MD|
|Sub-Investigator: Xavier ROBLIN, PhD|
|Principal Investigator:||Pauline VEYRARD, MD||CHU SAINT-ETIENNE|