Ulcerative colitis
Conditions
Interventions
Trade Name: Entyvio
Pharmaceutical Form: Powder for solution for infusion
Sponsors
Academic Medical Center/ Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements. 2. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Age 18 to 80 4. Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]). 5. Established diagnosis of ulcerative colitis with histopathological confirmation available in the record of the patient. 6. Moderate to severe active UC (total Mayo score > 6) with objective evidence of inflammation that can be visualized on endoscopy. All endscopies will be video-taped for later review, rereading and quality assurance. Patients must have an endoscopic Mayo score of 2 or 3. 7. Anti-TNF discontinued for at least 6 weeks 8. Written informed consent must be obtained and documented GROUP 1 (EARLY UC) 1. Diagnosis of UC 1 course of steroids per year or: steroid dependency at any dose GROUP 2 (LATE UC) 1. Diagnosis of UC confirmed by clinical, endoscopic and histopathological evidence. 2. Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates and: failure to respond to at least 3 months of thiopurines or intolerance to TP and: failure to respond to at least 1 anti-TNF or intolerance to anti-TNF or loss of response to at least 1 anti-TNF. Loss of response to anti-TNF is defined as recurrence of symptoms during maintenance dosing following prior clinical benefit. May continue stable dose of conventional therapies for IBD incl aminosalicylates and thiopurines and corticosteroids. Steroids will be tapered by protocol by week 14. Anti-TNF must be discontinued for > 6 weeks. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Prior treatment with vedolizumab. 2. Contraindication for endoscopy. 3. History of colonic dysplasia/cancer 4. Extensive colonic resection, i.e. subtotal or total colectomy with <15 cm colon remaining 5. Received other biologics within the last 6 weeks of screening 6. Use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment 7. Chronic hepatitis B or C infection 8. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment 9. Active or latent tuberculosis 10. Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures. 11. Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer. 12. Positive PML subjective symptom checklist before enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this prospective open label study is to assess the ability of vedolizumab to promote clinical, endoscopic and histological remission in patients with active UC in an 'early' and a 'late' disease population after 54 weeks of treatment.;Secondary Objective: Measures of clinical disease activity (including clinical response and remission) over the 1 year study period will be described. The mucosal healing capacity of vedolizumab treatment will be observed by assessing the endoscopic and histopathologic response to treatment over the 1 year study period. ;Primary end point(s): The primary endpoint is the proportion of patients with clinical and endoscopic remission at Week 26 and 52-54, defined as a Mayo Clinic score =2 and no subscore >1 .;Timepoint(s) of evaluation of this end point: Week 26 and week 52-54 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints for this study are: - Proportion of patients with endoscopic response (decrease of 1 point or more in the Mayo endoscopic score) at Weeks 26 and 52 - Proportion of patients with clinical response (defined as reduction in Mayo clinic score of at least 3 points and a decrease of at least 30% from baseline, with an accompanying decrease in the rectal bleeding subscore of at least 1 point or an absolute rectal bleeding subscore of 0 or 1) at all time points - Proportion of patients with clinical remission (Mayo Clinic score =2 and no subscore >1) at all time other points - Proportion of patients with corticosteroid- free clinical remission (Mayo Clinic score =2 and no subscore >1) at all other time points - Proportion of patients with normalized serum CRP at all time points - Proportion of patients with 25%, 50% and 75% reduction in the Geboes histology score at Weeks 26 and 52. - Proportion of patients with sustained clinical response (response at all time points after week 10) - Proportion of patients with sustained clinical remission (remission at all time points after week 10) - Proportion of patients that need to be hospitalized - Quality of life measured by IBDQ and Euroquol - Work productivity Index - WHO Disability Index - Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion ;Timepoint(s) of evaluation of this end point: week 26 and week 52 | — |
Countries
Belgium, Hungary, Netherlands
Contacts
Public ContactIBD trial Office
Academic Medical Center
Outcome results
None listed