NCT00355901

Brief Summary

To assess the effects of visilizumab on the safety of subsequent salvage therapies in subjects who experienced disease progression in a previous visilizumab study and subsequently received salvage therapy.

Trial Health

68
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2006

Longer than P75 for all trials

Geographic Reach
13 countries

36 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

July 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 25, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 5, 2008

Status Verified

August 1, 2008

First QC Date

July 21, 2006

Last Update Submit

August 2, 2008

Conditions

Keywords

Ulcerative ColitisColitisSteroid-RefractoryVisilizumabIntravenous Steroid-Refractory Ulcerative Colitis (IVSR-UC)

Interventions

Eligibility Criteria

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

You may qualify if:

  • Previous participation in a visilizumab study of IVSR-UC.
  • Disease progression while enrolled in a previous visilizumab study, and subsequent treatment with salvage therapy.

You may not qualify if:

  • Unable to understand the purpose and risks of the study, or unwilling or unable to provide a signed and dated informed consent.
  • For U.S. sites, unwilling or unable to provide authorization to use protected health information.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (40)

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Gainesville, Florida, 32610, United States

Location

Unknown Facility

Atlanta, Georgia, 30342, United States

Location

Unknown Facility

Louisville, Kentucky, 40202, United States

Location

Unknown Facility

Worcester, Massachusetts, 01655, United States

Location

Unknown Facility

Rochester, Minnesota, 55905, United States

Location

Unknown Facility

St Louis, Missouri, 63110, United States

Location

Unknown Facility

Manhasset, New York, 11030, United States

Location

Unknown Facility

Mineola, New York, 11501, United States

Location

Unknown Facility

New York, New York, 10021, United States

Location

Unknown Facility

New York, New York, 10029, United States

Location

Unknown Facility

Cleveland, Ohio, 44106, United States

Location

Unknown Facility

Hershey, Pennsylvania, 17033, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Salt Lake City, Utah, 84107, United States

Location

Unknown Facility

Bedford Park, South Australia, Australia

Location

Unknown Facility

Box Hill, Victoria, Australia

Location

Unknown Facility

Fremantle, 6160, Australia

Location

Unknown Facility

Liverpool, 2170, Australia

Location

Unknown Facility

Vienna, A-1090, Austria

Location

Unknown Facility

Ghent, B-9000, Belgium

Location

Unknown Facility

Leuven, 3000, Belgium

Location

Unknown Facility

Roeselare, 8800, Belgium

Location

Unknown Facility

Winnipeg, Manitoba, R3A-139, Canada

Location

Unknown Facility

Hamilton, Ontario, L8N 3Z5, Canada

Location

Unknown Facility

Brno, Czechia

Location

Unknown Facility

Prague, Czechia

Location

Unknown Facility

Amiens, 80054, France

Location

Unknown Facility

Lille, 59037, France

Location

Unknown Facility

Paris, 75010, France

Location

Unknown Facility

Freiburg im Breisgau, D-79106, Germany

Location

Unknown Facility

Béri Balogh Adám, H-7100, Hungary

Location

Unknown Facility

Vác, H-2601, Hungary

Location

Unknown Facility

Vásvari Pál, H-9024, Hungary

Location

Unknown Facility

Dublin, Ireland

Location

Unknown Facility

Bologna, 40138, Italy

Location

Unknown Facility

Amsterdam, 1105 AZ, Netherlands

Location

Unknown Facility

Oslo, Norway

Location

Unknown Facility

Tromsø, Norway

Location

Unknown Facility

Kharkiv, 61001, Ukraine

Location

MeSH Terms

Conditions

Colitis, UlcerativeColitis

Interventions

visilizumab

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 21, 2006

First Posted

July 25, 2006

Study Start

September 1, 2006

Study Completion

November 1, 2012

Last Updated

August 5, 2008

Record last verified: 2008-08

Locations