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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

Summary

The purpose of this multicenter, open-label study is to collect data on the occurrence of important clinical safety events resulting from chronic vedolizumab (MLN0002) administration.

Official Title

A Phase 3, Open-label Study to Determine the Long-term Safety and Efficacy of Vedolizumab (MLN0002) in Subjects With Ulcerative Colitis and Crohn's Disease

Details

The drug being tested in this study is called vedolizumab. Vedolizumab is being tested to treat people who have ulcerative colitis or Crohn's disease. This study will determine the safety profile of long-term vedolizumab treatment.

The study enrolled 2243 patients. Participants who received either placebo or vedolizumab 300 mg IV infusion every 4 or 8 weeks in previous vedolizumab studies received:

• Vedolizumab 300 mg

All participants received vedolizumab intravenous infusion every 4 weeks for up to 46 months.

This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to March 2016 until vedolizumab was available in the country in which the participant resided, or until participant withdrawal, whichever came first. Participants made multiple visits to the clinic up to 16 weeks after receiving their last dose of vedolizumab and were being followed up for 2-years during which a safety questionnaire was administered by telephone for follow-up assessments.

Keywords

Ulcerative Colitis Crohn's Disease Drug therapy Vedolizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), Study C13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of the investigator, was well tolerated OR b. Moderate to severe Crohn's disease or ulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
  2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol

You CAN'T join if...

  1. Development of any new, unstable, or uncontrolled disease

Locations

  • San Francisco, California, 94115, United States
  • San Diego, California, 92114, United States
  • Portland, Oregon, 97225, United States
  • Lafayette, Colorado, 80026, United States
  • Littleton, Colorado, 80120, United States
  • Thorton, Colorado, 80229, United States
  • Edmonton, Alberta, T6G2X8, Canada
  • Saskatoon, Saskatchewan, S7N 0W8, Canada
  • Topeka, Kansas, 66606, United States
  • San Antonio, Texas, 78229, United States
  • Tyler, Texas, 75701, United States
  • Rochester, Minnesota, 55904, United States
  • Germantown, Tennessee, 38138, United States
  • Baton Rouge, Louisiana, 70809, United States
  • Milwaukee, Wisconsin, 53226, United States
  • Louisville, Kentucky, 40202, United States
  • Birmingham, Alabama, 35233, United States
  • Ann Arbor, Michigan, 48109, United States
  • Troy, Michigan, 48098, United States
  • Decatur, Georgia, 30033, United States
  • Atlanta, Georgia, 30024, United States
  • Macon, Georgia, 31201, United States
  • Elkin, North Carolina, 28621, United States
  • Charlotte, North Carolina, 28207, United States
  • Jacksonville, Florida, 32256, United States
  • Charlottesville, Virginia, 22908, United States
  • Winter Park, Florida, 32789, United States
  • Richmond, Virginia, 23249, United States
  • Chevy Chase, Maryland, 20815, United States
  • Miami, Florida, 33172, United States
  • Cheektowaga, New York, 10029, United States
  • New York, New York, 10029, United States
  • Hamden, Connecticut, 06518, United States
  • Leuven, 3000, Belgium
  • Halle, ST, 6097, Germany
  • Seoul, 130-702, Korea, Republic of
  • Praha, 170 04, Czech Republic
  • Szekszard, 7100, Hungary
  • Tel Aviv, 64239, Israel
  • Adelaide, South Australia, 5000, Australia
  • Kuala Lumpur, 59100, Malaysia

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Takeda
ID
NCT00790933
Phase
Phase 3
Lead Scientist
Uma Mahadevan
Study Type
Interventional
Last Updated
February 1, 2017