VEDO - PREDIRESPUC project - Vedolizumab and anti-vedolizumab antibody in the prediction of therapeutic response in Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; MedDRA version: 20.1Level: LLTClassification code 10066678Term: Acute ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-001051-12-FR
• Lead Sponsor: CHU Saint-Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-19
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 125

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 ECCO recommendations.
-Informed written consent given

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 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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

Study & Design

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