An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease

Last updated: May 2, 2022
Sponsor: Takeda
Overall Status: Completed

Phase

3

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Ulcers

Treatment

N/A

Clinical Study ID

NCT00790933
C13008
NL25209.096.08
2008-002784-14
CTRI/2009/091/000138
NMRR-08-1040-2195
10/H1102/12
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Previous treatment in Study C13004 (NCT00619489), Study C13006 (NCT00783718), StudyC13007 (NCT00783692), or Study C13011 (NCT01224171) that, in the opinion of theinvestigator, was well tolerated OR b. Moderate to severe Crohn's disease orulcerative colitis which has not been previously treated with vedolizumab (MLN0002)
  2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease orulcerative colitis as defined by the protocol

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 2243
Study Start date:
May 22, 2009
Estimated Completion Date:
October 31, 2017

Study Description

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 approximately up to 510 weeks.

This multicenter trial is being conducted worldwide. The overall time to participate in this study was up to October 2017 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.

Connect with a study center

  • Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Leuven, 3000
    Belgium

    Site Not Available

  • Edmonton, Alberta T6G2X8
    Canada

    Site Not Available

  • Saskatoon, Saskatchewan S7N 0W8
    Canada

    Site Not Available

  • Praha, 170 04
    Czechia

    Site Not Available

  • Halle, Saint 6097
    Germany

    Site Not Available

  • Szekszard, 7100
    Hungary

    Site Not Available

  • Tel Aviv, 64239
    Israel

    Site Not Available

  • Seoul, 130-702
    Korea, Republic of

    Site Not Available

  • Kuala Lumpur, 59100
    Malaysia

    Site Not Available

  • Birmingham, Alabama 35233
    United States

    Site Not Available

  • San Diego, California 92114
    United States

    Site Not Available

  • San Francisco, California 94115
    United States

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  • Lafayette, Colorado 80026
    United States

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  • Littleton, Colorado 80120
    United States

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  • Thornton, Colorado 80229
    United States

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  • empty

    Thorton, Colorado 80229
    United States

    Site Not Available

  • Hamden, Connecticut 06518
    United States

    Site Not Available

  • Jacksonville, Florida 32256
    United States

    Site Not Available

  • Miami, Florida 33172
    United States

    Site Not Available

  • Winter Park, Florida 32789
    United States

    Site Not Available

  • Atlanta, Georgia 30024
    United States

    Site Not Available

  • Decatur, Georgia 30033
    United States

    Site Not Available

  • Macon, Georgia 31201
    United States

    Site Not Available

  • Topeka, Kansas 66606
    United States

    Site Not Available

  • Louisville, Kentucky 40202
    United States

    Site Not Available

  • Baton Rouge, Louisiana 70809
    United States

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  • Chevy Chase, Maryland 20815
    United States

    Site Not Available

  • Ann Arbor, Michigan 48109
    United States

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  • Troy, Michigan 48098
    United States

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  • Rochester, Minnesota 55904
    United States

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  • Cheektowaga, New York 10029
    United States

    Site Not Available

  • New York, New York 10029
    United States

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  • Charlotte, North Carolina 28207
    United States

    Site Not Available

  • Elkin, North Carolina 28621
    United States

    Site Not Available

  • Portland, Oregon 97225
    United States

    Site Not Available

  • Germantown, Tennessee 38138
    United States

    Site Not Available

  • San Antonio, Texas 78229
    United States

    Site Not Available

  • Tyler, Texas 75701
    United States

    Site Not Available

  • Charlottesville, Virginia 22908
    United States

    Site Not Available

  • Richmond, Virginia 23249
    United States

    Site Not Available

  • Milwaukee, Wisconsin 53226
    United States

    Site Not Available

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