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

Study Purpose

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.

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03237260

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 4

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
University of Pennsylvania

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Nabeel Khan, MD
Principal Investigator Affiliation Assistant Professor of Clinical Medicine

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
OtherIndustryU.S. Fed
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Recruiting

Address

Corporal Michael J. Crescenz VA Medical Center

Philadelphia, Pennsylvania, 19104

Site Contact

Nabeel Khan, MD

Nabeel.Khan@va.gov

215-823-5800

Philadelphia, Pennsylvania

Status

Recruiting

Address

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, 19104

Site Contact

Jan-Michael Klapproth, MD

janmichael.klapproth@uphs.upenn.edu

215-349-8222

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