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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2024-02-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis

NCT02497469

Colitis, Ulcerative

COMPLETED PHASE3

EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis

NCT03679546

Ulcerative Colitis

COMPLETED PHASE4

Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis

NCT03029143

Colitis, Ulcerative

COMPLETED PHASE4

Efficacy and Safety of Vedolizumab Combined With Upadacitinib in Patients With Ulcerative Colitis

NCT06095596

Ulcerative Colitis (UC)

RECRUITING NA

Value of Pharmacokinetic Assays in the Prediction of Therapeutic Response in Ulcerative Colitis

NCT03724929

Ulcerative Colitis

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis, Unspecified

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Experimental group

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

Group Type EXPERIMENTAL

Valganciclovir

Intervention Type DRUG

The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Valganciclovir

The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

antiviral therapy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No