Last updated on October 2020

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ulcerative Colitis
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • - Aged over 18 years
  • Men or non-pregnant women
  • Patients with a diagnosis of ulcerative colitis who requires to start VDZ
  • Moderate to severe active ulcerative colitis defined as a total mayo score ranging from 6 to 12 and endoscopic Mayo score above 1
  • UC patients with previous failure with TNF antagonist agents and unacceptable side-effects from steroids, and/or immunosuppressive agents (i.e., azathioprine, 6-mercaptopurine, or methotrexate). In France, VDZ has to be prescribed only in patients in failure or intolerant to anti-TNF.
  • Stable doses of oral prednisone (30 mg per day) or budesonide (9 mg per day), are allowed at stable dose for at least 4 weeks-before inclusion. Concomitant immunosuppressive agents, mesalamine, are allowed at stable dose for at least three months before inclusion. Steroid tapering has to be set up at Week 6 after starting VDZ, according to the European Crohn's and Colitis Organisation (ECCO) recommendations.
  • Informed written consent given.

Exclusion Criteria:

  • - Existing pregnancy, lactation, or intended pregnancy within the next 15 months
  • Minors or History of disease, including mental/emotional disorder that might interfere with their participation in the study
  • Serious secondary illnesses of an acute or chronic nature, which in the opinion of the investigator renders the patient unsuitable for inclusion into the study
  • Inability to comply with the protocol requirements
  • Inability to fill in the diary cards during the last 7 days before each visit
  • Severe Acute UC needed hospitalisation
  • Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years)
  • Short bowel syndrome
  • Previous treatments with vedolizumab, natalizumab, efalizumab or rituximab.
  • Previous treatment with adalimumab within 30 days prior enrollment or infliximab and certolizumab pegol within 60 days before enrollment
  • Prior extensive colonic resection, obstructive (symptomatic) intestinal stricture, abdominal abscess, active or latent tuberculosis,
  • Clostridium difficile superinfection;
  • Indeterminate colitis
  • Concomitant leukocyte apheresis.
  • Any contraindication to vedolizumab therapy
  • Patients who denied the protocol, not ability to accept or sign consent of the protocol
  • Subject involved in another clinical trial

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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