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Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy (CYTOVEDO)

Primary Purpose

Ulcerative Colitis, Unspecified

Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Valganciclovir
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis, Unspecified focused on measuring Ulcerative Colitis (UC), CytoMegaloVirus (CMV), Vedolizumab, Valganciclovir, Anti-TNF, Mayo score

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient with moderate to severe active Ulcerative Colitis (UC) defined by a Mayo score greater than 5

  • Patient with an inflammatory outbreak of Ulcerative Colitis (UC) :

    • without anti-TNF
    • under anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure).
  • Having rectosigmoidoscopy with an endoscopic Mayo score≥ 2 with 2 biopsies of the inflammatory tissue
  • Presence of a CytoMegaloVirus (CMV) infection in the inflammatory tissue (viral load greater than 5 IU / 100000 cells by qPCR)
  • Patient with a negative pre-treatment assessment including HIV, HBV, HCV, HCV serology, a negative quantiferon or a history of tuberculosis preventive treatment adapted by Rifinah or Rimifon
  • Signed informed consent

Exclusion Criteria:

  • Patient with severe acute colitis
  • Patient treated by ciclosporin or Prograf
  • Patient with Human Immunodeficiency Virus (HIV)+, hepatitis B, hepatitis C, tuberculosis
  • Clostridium difficile infection.
  • Patient with intolerance or contraindications to current therapy
  • Pregnant or starts breastfeeding
  • Patient who received a live vaccine in the month preceding the study
  • Patients with severe renal insufficiency defined by creatinine clearance <30ml/minute, or hemodialysed

Sites / Locations

  • CH d'AnnecyRecruiting
  • CHU de Clermont-Ferrand
  • CHU de Grenoble
  • CHU de Lyon SudRecruiting
  • CHU de Montpellier
  • CHU de NiceRecruiting
  • APHP - Hôpital Saint-AntoineRecruiting
  • CHU ROUEN - Service Gastro-entérologie
  • CHU de Saint EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental group

Arm Description

Patient will be treated by vedolizumab the standard of care alone.

Patient will be treated by vedolizumab the standard of care associated at valganciclovir.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Mucosal healing
Percentage of patients in mucosal healing defined by endoscopic mayo score <2
Viral load CytoMegaloVirus (CMV)
Value of viral load CytoMegaloVirus (CMV) by qPCR on inflammatory tissue in IU / 100000 cells.
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.
Rate of colectomy
Percentage of patients who required colectomy
Adverse effects
Number and severity of adverse effects
viral load of the Torque teno virus
performed on the blood tube and tissue biopsies

Full Information

First Posted
August 20, 2019
Last Updated
June 6, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT04064697
Brief Title
Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy
Acronym
CYTOVEDO
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Unspecified
Keywords
Ulcerative Colitis (UC), CytoMegaloVirus (CMV), Vedolizumab, Valganciclovir, Anti-TNF, Mayo score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patient will be treated by vedolizumab the standard of care alone.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patient will be treated by vedolizumab the standard of care associated at valganciclovir.
Intervention Type
Drug
Intervention Name(s)
Valganciclovir
Other Intervention Name(s)
antiviral therapy
Intervention Description
The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks
Primary Outcome Measure Information:
Title
Clinical response
Description
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
Secondary Outcome Measure Information:
Title
Clinical remission
Description
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
Title
Mucosal healing
Description
Percentage of patients in mucosal healing defined by endoscopic mayo score <2
Time Frame
Weeks 6
Title
Viral load CytoMegaloVirus (CMV)
Description
Value of viral load CytoMegaloVirus (CMV) by qPCR on inflammatory tissue in IU / 100000 cells.
Time Frame
Weeks 6
Title
clinical remission
Description
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
Title
Rate of colectomy
Description
Percentage of patients who required colectomy
Time Frame
Weeks 52
Title
Adverse effects
Description
Number and severity of adverse effects
Time Frame
Weeks 52
Title
viral load of the Torque teno virus
Description
performed on the blood tube and tissue biopsies
Time Frame
Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with moderate to severe active Ulcerative Colitis (UC) defined by a Mayo score greater than 5 Patient with an inflammatory outbreak of Ulcerative Colitis (UC) : without anti-TNF under anti-TNF (infliximab, adalimumab, golimumab) after induction (no primary response) or clinical recurrence (secondary failure). Having rectosigmoidoscopy with an endoscopic Mayo score≥ 2 with 2 biopsies of the inflammatory tissue Presence of a CytoMegaloVirus (CMV) infection in the inflammatory tissue (viral load greater than 5 IU / 100000 cells by qPCR) Patient with a negative pre-treatment assessment including HIV, HBV, HCV, HCV serology, a negative quantiferon or a history of tuberculosis preventive treatment adapted by Rifinah or Rimifon Signed informed consent Exclusion Criteria: Patient with severe acute colitis Patient treated by ciclosporin or Prograf Patient with Human Immunodeficiency Virus (HIV)+, hepatitis B, hepatitis C, tuberculosis Clostridium difficile infection. Patient with intolerance or contraindications to current therapy Pregnant or starts breastfeeding Patient who received a live vaccine in the month preceding the study Patients with severe renal insufficiency defined by creatinine clearance <30ml/minute, or hemodialysed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pauline VEYRARD, MD
Phone
(0)477828619
Ext
+33
Email
pauline.veyrard@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie PEURIERE, CRA
Phone
(0)477120826
Ext
+33
Email
Marie.Peuriere@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pauline VEYRARD, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CH d'Annecy
City
Annecy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Heluwaert, MD
First Name & Middle Initial & Last Name & Degree
Joanna Pofelski, MD
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Buisson, MD
Facility Name
CHU de Grenoble
City
Grenoble
Country
France
Individual Site Status
Withdrawn
Facility Name
CHU de Lyon Sud
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephane Nancey, PhD
First Name & Middle Initial & Last Name & Degree
Pauline Danion, MD
First Name & Middle Initial & Last Name & Degree
Bernard Flourie, MD
First Name & Middle Initial & Last Name & Degree
Gilles Boschetti, MD
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Romain Altwegg, MD
First Name & Middle Initial & Last Name & Degree
Lucile Boivineau, MD
Facility Name
CHU de Nice
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Hebuterne, PhD
First Name & Middle Initial & Last Name & Degree
Nadia Arab, MD
First Name & Middle Initial & Last Name & Degree
Julie Benard, MD
Facility Name
APHP - Hôpital Saint-Antoine
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Sokol, PhD
Facility Name
CHU ROUEN - Service Gastro-entérologie
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas SAVOYE, MD
Facility Name
CHU de Saint Etienne
City
Saint-Étienne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline VEYRARD, MD
First Name & Middle Initial & Last Name & Degree
Xavier ROBLIN, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy

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