Status:
TERMINATED
Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy
Lead Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Ulcerative Colitis, Unspecified
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 th...
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, a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2024
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT04064697
Start Date
April 22 2021
End Date
February 8 2024
Last Update
April 10 2024
Active Locations (8)
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1
CH d'Annecy
Annecy, France
2
CHU de Clermont-Ferrand
Clermont-Ferrand, France
3
CHU de Lyon Sud
Lyon, France
4
CHU de Montpellier
Montpellier, France