An open-label study to evaluate the effectiveness, safety and the healing of the mucosa of the bowel of vedolizumab in subject with early onset on Crohn's disease versus subject with longer exisiting Crohn's disease.

Phase 1

• Conditions: Active Crohn's disease; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2014-005376-29-BE
• Lead Sponsor: Academic Medical Center, Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-03
• Last Update Posted: 16 August 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

- Established diagnosis of ileal, ileocolonic or colonic Crohn’s disease with histopathological confirmation available in the record of the patient.
- Moderately to severely active CD (CDAI 220-450) with objective evidence of ulcerations visualized on endoscopy.
- Anti-TNF discontinued for at least 6 weeks
-Age 18 to 80

- GROUP 1 (EARLY CD):
Diagnosis of CD < 24 months prior to enrollment
Demonstrated failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
or: need for > 2 courses of steroids since diagnosis
or: steroid dependency at any dose since diagnosis

GROUP 2 (LATE CD)
Demonstrated failure to respond to at least 3 months of thiopurines or intolerance to thiopurines 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.

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 240
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

- Prior treatment with vedolizumab.
- Contraindication for endoscopy.
- History of colonic dysplasia/cancer
- Presence of stoma
- Received other biologics within the last 6 weeks of screening
- use of 5-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
- chronic hepatitis B or C infection
- Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment
- Active or latent tuberculosis
- Conditions which in the opinion of the investigator may interfere with the subject’s ability to comply with the study procedures.
- Received any investigational drug in the past 30 days or 5 half-lives, whichever is longer.
- Positive PML subjective symptom checklist before enrollment.
- Subjects with known allergy or hyposensitivity to vedolizumab or its components

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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 Crohn's disease 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 CDAI of 150 or lower and SES-CD <4.;Timepoint(s) of evaluation of this end point: Week 26 and week 52