An Open Label Single-arm Phase 4 Study of Vedolizumab in Subjects With Newly Diagnosed Active Ulcerative Colitis
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 8/30/2018 |
| Start Date: | July 1, 2017 |
| End Date: | July 2022 |
| Contact: | Nabeel Khan |
| Email: | Nabeel.Khan@va.gov |
| Phone: | 215-823-5800 |
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.
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.
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
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