NCT00032305

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2002

Typical duration for phase_2

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2002

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 14, 2002

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2002

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2005

Completed
Last Updated

March 7, 2012

Status Verified

March 1, 2012

Enrollment Period

3.7 years

First QC Date

March 14, 2002

Last Update Submit

March 6, 2012

Conditions

Ulcerative Colitis

Keywords

ColitisGastrointestinal DiseaseDigestive System DiseaseIntestinal DiseaseColonic Disease

Interventions

VisilizumabDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (7)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Location

University of California

San Francisco, California, 94115, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Mount Sinai School of Medicine

New York, New York, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

Location

Related Publications (1)

  • Plevy S, Salzberg B, Van Assche G, Regueiro M, Hommes D, Sandborn W, Hanauer S, Targan S, Mayer L, Mahadevan U, Frankel M, Lowder J. A phase I study of visilizumab, a humanized anti-CD3 monoclonal antibody, in severe steroid-refractory ulcerative colitis. Gastroenterology. 2007 Nov;133(5):1414-22. doi: 10.1053/j.gastro.2007.08.035. Epub 2007 Aug 21.

    PMID: 17920064DERIVED

MeSH Terms

Conditions

Colitis, UlcerativeColitisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColonic Diseases

Interventions

visilizumab

Condition Hierarchy (Ancestors)

GastroenteritisInflammatory Bowel Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2002

First Posted

March 18, 2002

Study Start

March 1, 2002

Primary Completion

November 1, 2005

Study Completion

November 1, 2005

Last Updated

March 7, 2012

Record last verified: 2012-03

Locations

US(7)