Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
NCT ID: NCT01224171
Last Updated: 2014-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
416 participants
INTERVENTIONAL
2010-11-30
2012-04-30
Brief Summary
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Detailed Description
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Participants who did not enroll in Study C13008 were to complete the Final Safety visit (16 weeks after the last dose of study drug) for a maximum time on study of 22 weeks.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
Placebo
Placebo intravenous infusion
Vedolizumab
Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
vedolizumab
Vedolizumab for intravenous infusion
Interventions
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vedolizumab
Vedolizumab for intravenous infusion
Placebo
Placebo intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of moderately to severely active Crohn's disease
* Crohn's Disease involvement of the ileum and/or colon
* Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
* May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Exclusion Criteria
* Extensive colonic resection, subtotal or total colectomy
* History of \>3 small bowel resections or diagnosis of short bowel syndrome
* Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
* Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
* Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
* Active or latent tuberculosis
18 Years
80 Years
ALL
No
Sponsors
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Millennium Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Millennium Pharmaceuticals, Inc.
Locations
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Gastroenterology of the Rockies
Lafayette, Colorado, United States
Gastroenterology Center of Connecticut P.C.
Hamden, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
Atlanta Gastroenterology Specialist PC
Suwanee, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, United States
University of Kentucky Medical Center
Lexington, Kentucky, United States
University Of Louisville
Louisville, Kentucky, United States
Gastroenterology Associates
Baton Rouge, Louisiana, United States
Gastroenterology Research of New Orleans
Hammond, Louisiana, United States
Metropolitan Gastroenterology Group P.C.
Chevy Chase, Maryland, United States
Mid-Atlantic Medical Research Center
Hollywood, Maryland, United States
Massachusetts General Hospital Crohn's and Colitis Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Minnesota Gastroenterology P.A.
Plymouth, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
New York Presbyterian Hospital
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroenterology and Hepatology P.L.L.C
Charlotte, North Carolina, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States
Options Health Research
Tulsa, Oklahoma, United States
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, United States
Consultants in Gastroenterology
Columbia, South Carolina, United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
University of Virginia Health System
Charlottesville, Virginia, United States
University of Washington School of Medicine
Seattle, Washington, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, United States
Zeidler Ledcor Center-Univerisity of Alberta
Edmonton, Alberta, Canada
Countries
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References
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Sands BE, Van Assche G, Tudor D, Akhundova-Unadkat G, Curtis RI, Tan T. Vedolizumab in Combination With Corticosteroids for Induction Therapy in Crohn's Disease: A Post Hoc Analysis of GEMINI 2 and 3. Inflamm Bowel Dis. 2019 Jul 17;25(8):1375-1382. doi: 10.1093/ibd/izy384.
Feagan BG, Sandborn WJ, Colombel JF, Byrne SO, Khalid JM, Kempf C, Geransar P, Bhayat F, Rubin DT. Incidence of Arthritis/Arthralgia in Inflammatory Bowel Disease with Long-term Vedolizumab Treatment: Post Hoc Analyses of the GEMINI Trials. J Crohns Colitis. 2019 Jan 1;13(1):50-57. doi: 10.1093/ecco-jcc/jjy125.
Feagan BG, Lasch K, Lissoos T, Cao C, Wojtowicz AM, Khalid JM, Colombel JF. Rapid Response to Vedolizumab Therapy in Biologic-Naive Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2019 Jan;17(1):130-138.e7. doi: 10.1016/j.cgh.2018.05.026. Epub 2018 May 29.
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.
Rosario M, Dirks NL, Gastonguay MR, Fasanmade AA, Wyant T, Parikh A, Sandborn WJ, Feagan BG, Reinisch W, Fox I. Population pharmacokinetics-pharmacodynamics of vedolizumab in patients with ulcerative colitis and Crohn's disease. Aliment Pharmacol Ther. 2015 Jul;42(2):188-202. doi: 10.1111/apt.13243. Epub 2015 May 20.
Sands BE, Feagan BG, Rutgeerts P, Colombel JF, Sandborn WJ, Sy R, D'Haens G, Ben-Horin S, Xu J, Rosario M, Fox I, Parikh A, Milch C, Hanauer S. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014 Sep;147(3):618-627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21.
Other Identifiers
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U1111-1158-2581
Identifier Type: REGISTRY
Identifier Source: secondary_id
2009-016488-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL34356.078.10
Identifier Type: REGISTRY
Identifier Source: secondary_id
C13011
Identifier Type: -
Identifier Source: org_study_id
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