Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Centre Hospitalier Universitaire de Saint Etienne
With
Ministry of Health, France
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Impact of Anti-cytomegalovirus Treatment in the Management of Relapsing Ulcerative Colitis Requiring Vedolizumab Therapy
