Research Study in Patients With Severe Ulcerative Colitis

Last updated: March 6, 2012
Sponsor: Facet Biotech
Overall Status: Completed

Phase

2/3

Condition

Ulcerative Colitis

Colic

Ulcers

Treatment

N/A

Clinical Study ID

NCT00032305
291-406
  • Ages 18-70
  • All Genders

Study Summary

The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy. The research is being conducted at up to 8 clinical research sites in the US and is open to both men and women ages 18 to 70 years old. Participants in the study will have a number of visits to a research site. All study-related care and medication is provided to qualified participants at no cost: this includes all visits, examinations and laboratory work.

Eligibility Criteria

Inclusion

  1. A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry.

  2. Active disease despite ongoing treatment with steroids

Study Design

Total Participants: 20
Study Start date:
March 01, 2002
Estimated Completion Date:
November 30, 2005

Study Description

A Phase I, dose-escalation, pilot study designed to obtain safety and tolerability data on visilizumab administered to patients with severe ulcerative colitis that has failed to respond to steroid therapy. Patients who are currently receiving IV corticosteroids, but whose disease has not responded after at least 5 days of this therapy, will be eligible for the study.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California
    United States

    Site Not Available

  • University of California

    San Francisco, California 94115
    United States

    Site Not Available

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia
    United States

    Site Not Available

  • The University of Chicago Medical Center

    Chicago, Illinois
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mount Sinai School of Medicine

    New York, New York
    United States

    Site Not Available

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania
    United States

    Site Not Available

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