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

Phase 1

• Conditions: 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: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code 10058881Term: Cytomegalovirus viremiaSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-001032-54-FR
• Lead Sponsor: CHU de Saint Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-19
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 :<br><br>- clinical remission rates at week 6,<br>- mucosal healing rates at week 6,<br>- CMV viral load (qPCR in inflammatory tissue) at week 6<br>- clinical remission rates at week 52<br>- the colectomy rate at week 52<br><br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Clinical remission at week 6<br>- Clinical remission at week 52 <br>- Viral load in tissue at week 6<br>- Mucosal healing at week 6 <br>- Adverse effects in both arms <br>- Rate of colectomy at week 52<br>;Timepoint(s) of evaluation of this end point: week 6 and week 52