An Open-label Study of Vedolizumab (MLN0002) in Participants With Ulcerative Colitis and Crohn's Disease
NCT ID: NCT00790933
Last Updated: 2022-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2243 participants
INTERVENTIONAL
2009-05-22
2017-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Vedolizumab 300 mg
Vedolizumab 300 mg, 30-minute intravenous (IV) infusion every 4 weeks, starting at Week 0 for approximately up to 510 weeks.
Vedolizumab
Vedolizumab intravenous infusion
Interventions
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Vedolizumab
Vedolizumab intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. May be receiving a therapeutic dose of conventional therapies for Crohn's disease or ulcerative colitis as defined by the protocol
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor Clinical Science
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
San Diego, California, United States
San Francisco, California, United States
Lafayette, Colorado, United States
Littleton, Colorado, United States
Thornton, Colorado, United States
Hamden, Connecticut, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Winter Park, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Macon, Georgia, United States
Topeka, Kansas, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Chevy Chase, Maryland, United States
Ann Arbor, Michigan, United States
Troy, Michigan, United States
Rochester, Minnesota, United States
Cheektowaga, New York, United States
New York, New York, United States
Charlotte, North Carolina, United States
Elkin, North Carolina, United States
Portland, Oregon, United States
Germantown, Tennessee, United States
San Antonio, Texas, United States
Tyler, Texas, United States
Charlottesville, Virginia, United States
Richmond, Virginia, United States
Milwaukee, Wisconsin, United States
Adelaide, South Australia, Australia
Leuven, , Belgium
Edmonton, Alberta, Canada
Saskatoon, Saskatchewan, Canada
Prague, , Czechia
Halle, Saint, Germany
Szekszárd, , Hungary
Tel Aviv, , Israel
Kuala Lumpur, , Malaysia
Seoul, , South Korea
Countries
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References
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Dulai PS, Feagan BG, Sands BE, Chen J, Lasch K, Lirio RA. Prognostic Value of Fecal Calprotectin to Inform Treat-to-Target Monitoring in Ulcerative Colitis. Clin Gastroenterol Hepatol. 2023 Feb;21(2):456-466.e7. doi: 10.1016/j.cgh.2022.07.027. Epub 2022 Aug 4.
Wyant T, Yang L, Lirio RA, Rosario M. Vedolizumab Immunogenicity With Long-Term or Interrupted Treatment of Patients With Inflammatory Bowel Disease. J Clin Pharmacol. 2021 Sep;61(9):1174-1181. doi: 10.1002/jcph.1877. Epub 2021 Jul 14.
Loftus EV Jr, Feagan BG, Panaccione R, Colombel JF, Sandborn WJ, Sands BE, Danese S, D'Haens G, Rubin DT, Shafran I, Parfionovas A, Rogers R, Lirio RA, Vermeire S. Long-term safety of vedolizumab for inflammatory bowel disease. Aliment Pharmacol Ther. 2020 Oct;52(8):1353-1365. doi: 10.1111/apt.16060. Epub 2020 Sep 2.
Feagan BG, Schreiber S, Wolf DC, Axler JL, Kaviya A, James A, Curtis RI, Geransar P, Stallmach A, Ehehalt R, Bokemeyer B, Khalid JM, O'Byrne S. Sustained Clinical Remission With Vedolizumab in Patients With Moderate-to-Severe Ulcerative Colitis. Inflamm Bowel Dis. 2019 May 4;25(6):1028-1035. doi: 10.1093/ibd/izy323.
Arijs I, De Hertogh G, Lemmens B, Van Lommel L, de Bruyn M, Vanhove W, Cleynen I, Machiels K, Ferrante M, Schuit F, Van Assche G, Rutgeerts P, Vermeire S. Effect of vedolizumab (anti-alpha4beta7-integrin) therapy on histological healing and mucosal gene expression in patients with UC. Gut. 2018 Jan;67(1):43-52. doi: 10.1136/gutjnl-2016-312293. Epub 2016 Oct 7.
Colombel JF, Sands BE, Rutgeerts P, Sandborn W, Danese S, D'Haens G, Panaccione R, Loftus EV Jr, Sankoh S, Fox I, Parikh A, Milch C, Abhyankar B, Feagan BG. The safety of vedolizumab for ulcerative colitis and Crohn's disease. Gut. 2017 May;66(5):839-851. doi: 10.1136/gutjnl-2015-311079. Epub 2016 Feb 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2008-002784-14
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NMRR-08-1040-2195
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTRI/2009/091/000138
Identifier Type: REGISTRY
Identifier Source: secondary_id
10/H1102/12
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL25209.096.08
Identifier Type: REGISTRY
Identifier Source: secondary_id
C13008
Identifier Type: -
Identifier Source: org_study_id
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