Status:
COMPLETED
A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
Lead Sponsor:
Takeda
Conditions:
Ulcerative Colitis
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, people with ulcerative colitis or Crohn's disease will be treated with vedolizumab. The mai...
Detailed Description
The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have active UC or CD. The study will enroll approximately 150 patients. Participants will be...
Eligibility Criteria
Inclusion
- Has a diagnosis of moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) at least 3 months prior to screening, with a Full Mayo Score of 6-12 for UC and a Harvey Bradshaw Index (HBI) score of \>=8 for CD at the time of enrolment.
- Has demonstrated, an inadequate response to, loss of response to, or intolerance to at least 1 of the following agents:
- Conventional therapy
- TNF-α alpha antagonist
Exclusion
- Has undergone an ileostomy, colostomy, or has known fixed symptomatic stenosis of the intestine.
- Has active or latent tuberculosis (TB).
- Has had a prior exposure to vedolizumab or a history of hypersensitivity or allergies to vedolizumab, natalizumab, efalizumab, or rituximab.
- Has a positive progressive multifocal leukoencephalopathy (PML) subjective symptom checklist during screening or prior to the administration of study drug on Day 1.
Key Trial Info
Start Date :
December 8 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 2 2024
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04804540
Start Date
December 8 2021
End Date
February 2 2024
Last Update
February 12 2025
Active Locations (17)
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1
Government General Hospital
Guntur, Andhra Pradesh, India, 522001
2
Institute of Gastroenterology and Liver Disease Dispur Hospitals
Guwahati, Assam, India, 781006
3
Indira Gandhi Institute of Medical Sciences
Patna, Bihar, India, 800014
4
Gastroplus Digestive Disease Centre Pvt.Ltd
Ahmedabad, Gujarat, India, 380054