Status:
WITHDRAWN
An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Takeda
Corporal Michael J. Crescenz VA Medical Center
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The purpose of this research study is to determine whether starting the drug vedolizumab earlier than its FDA approved use can lead to better control of UC then using older drugs that we have historic...
Detailed Description
Based upon our published data, 53% of patients who require CS at the time of diagnosis of UC will be in CS free remission in the absence of colectomy by the end of 52 weeks. Early corticosteroids requ...
Eligibility Criteria
Inclusion
- Newly diagnosed active ulcerative colitis, defined as a Mayo Clinic score of 6 to 12
- Prior Sigmoidoscopy sub score of at least 2, and disease that extended 15 cm or more from the anal verge
- Must have required CS for treatment of their symptoms within 2 weeks of diagnosis and have not reached symptom adequate response and they still have moderate to severe disease, indicated by a Mayo score 6 - 12
- In subjects that enroll and are eligible to continue in the study, study drug needs to be started within 3 months of the subject starting corticosteroids
Exclusion
- Currently treated with either anti-TNF therapy, immunomodulators or methotrexate due to the severity of their condition, making them not appropriate for vedolizumab
- Toxic megacolon, abdominal abscess, symptomatic colonic stricture, an increased risk of infectious complications
- An anticipated requirement for major surgery, colonic dysplasia or adenomas and malignant neoplasms
- Neurological disorders
- Pregnant or lactating females
- Clinical response to steroids prior to starting study drug
Key Trial Info
Start Date :
July 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03237260
Start Date
July 1 2017
End Date
February 1 2019
Last Update
July 8 2019
Active Locations (2)
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1
Corporal Michael J. Crescenz VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
2
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104