NL-OMON47577
Completed
Phase 4
An open label interventional phase 4 study to Evaluate Efficacy, Safety and Mucosal Healing of early versus late use of vedolizumab in ulcerative colitis: the LOVE-UC study (LOw countries VEdolizumab in UC study) - LOVE-UC
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Academisch Medisch Centrum
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age 18 to 80
- •2\. Established diagnosis of ulcerative colitis with histopathological confirmation available in the record of the patient.
- •3\. Moderate to severe active UC (total Mayo score \> 6\) with objective evidence of inflammation that can be visualized on endoscopy. Patients must have an endoscopic Mayo score of 2 or 3\.
- •4\. Anti\-TNF discontinued for at least 4 weeks before baseline;GROUP 1 (EARLY UC)
- •1\. Diagnosis of UC \< 4 years prior to enrollment confirmed by clinical, endoscopic and histopathological evidence.
- •2\. Demonstrated failure to respond to aminosalicylates or intolerance to aminoslicylates
- •and: failure to respond to topical or systemic corticosteroids or intolerance to corticosteroids
- •or: need for 1 course of steroids since diagnosis
- •and additionally, but not mandatory, lack of efficacy of thiopurines or intolerance to thiopurines (any duration). Patients who are using thiopurines (azathioprine, 6\-mercaptopurine or 6\-thioguanine) at screening must have used them for \> 3 months (last 4 weeks at stable dose).;GROUP 2 (LATE UC);1\. Diagnosis of UC \> 4 years confirmed by clinical, endoscopic and histopathological evidence.
- •2\. Demonstrated failure to respond to aminosalicylates or intolerance to aminosalicylates
Exclusion Criteria
- •1\. Prior treatment with vedolizumab; a4β7 anti\-bodies ; β7 antibodies ; anti\- MADCAM\-1 .
- •2\. History of colonic dysplasia or colonic cancer.
- •3\. Extensive colonic resection, i.e. subtotal or total colectomy with \<15 cm colon remaining
- •4\. Received other biologics within the last 4 weeks of baseline
- •5\. Use of 5\-ASA or corticosteroid enemas/suppositories within 2 weeks of enrollment
- •6\. Chronic hepatitis B or C infection
- •7\. Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening within 4 weeks prior to enrollment
- •8\. Active or latent tuberculosis
Outcomes
Primary Outcomes
Not specified
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