An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis

• Status: Withdrawn
• Trial end date: 2019-02-01
• Target enrollment: 0
• Participant gender: All

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 historically used to treat UC. Vedolizumab is FDA-approved to be used after initial Corticosteroid treatments have failed or other UC treatments have failed. We will study if using vedolizumab as an early treatment for your UC will allow you to get off corticosteroids and prevent UC from worsening and requiring surgery.

Vedolizumab is given intravenously initially every 2 weeks and then every 8 weeks.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Corporal Michael J. Crescenz VA Medical Center; Takeda
• Treatments: Vedolizumab

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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