Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
NCT ID: NCT00783718
Last Updated: 2014-07-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
895 participants
INTERVENTIONAL
2009-01-31
2012-03-31
Brief Summary
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Detailed Description
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* The Induction Phase, designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
* The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab for the maintenance of clinical response and remission.
The 6-week Induction Phase contained 2 cohorts of participants: Cohort 1 participants were randomized and treated with double-blind study drug, and Cohort 2 participants were treated with open-label vedolizumab. The second cohort was enrolled to ensure that the sample size of Induction Phase responders randomized into the Maintenance Study provided sufficient power for the Maintenance Study primary efficacy analysis. These participants did not contribute to the efficacy analyses performed for the Induction Study. Participants in both cohorts were assessed for treatment response at Week 6.
In the Maintenance Phase vedolizumab-treated participants from both Cohort 1 and Cohort 2 who demonstrated a clinical response were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks (Q4W), vedolizumab administered every 8 weeks (Q8W), or placebo. Vedolizumab-treated participants who did not demonstrate response at Week 6 continued treatment with open-label vedolizumab, administered Q4W. Participants treated with double-blind placebo in the Induction Phase continued on double-blind placebo during the Maintenance Phase, regardless of treatment response during induction. The Maintenance Phase began at Week 6 and concluded with Week 52 assessments.
After the Week 52 assessments, participants meeting protocol-defined criteria were eligible to enroll in Study C13008 (NCT00790933; Long-term Safety) to receive open-label vedolizumab treatment. Participants who withdrew early (prior to Week 52) due to sustained nonresponse, disease worsening, or the need for rescue medications may also have been eligible for Study C13008. Participants who did not enroll into Study C13008 were to complete a final on-study safety assessment at Week 66 (or final safety visit 16 weeks after the last dose) in the Maintenance Phase of Study C13006.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Vedolizumab
In the Induction Phase participants received vedolizumab 300 mg, administered by intravenous infusion at Week 0 and Week 2 (Days 1 and 15).
In the Maintenance Phase, participants who demonstrated a clinical response at Week 6 according to protocol-specified criteria were randomized in a 1:1:1 ratio to double-blind treatment with vedolizumab administered every 4 weeks, vedolizumab administered every 8 weeks, or placebo for up to Week 50. Participants who did not demonstrate response at Week 6 of the Induction Phase continued treatment with vedolizumab, administered every 4 weeks during the Maintenance Phase.
vedolizumab
Vedolizumab for intravenous infusion
Placebo
In the Induction Phase participants received placebo intravenous infusion at Week 0 and Week 2 (Days 1 and 15). Participants continued to receive placebo during the Maintenance Phase, regardless of treatment response during Induction.
Placebo
Placebo 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
2. Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance at least 1 of the following agents:
1. Immunomodulators
2. Tumor necrosis factor-alpha (TNFα) antagonists
3. Corticosteroids
3. May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Exclusion Criteria
2. Extensive colonic resection, subtotal or total colectomy
3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
4. Have received non permitted IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
5. Chronic hepatitis B or C infection
6. 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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University of Alabama at Birmingham
Birmingham, Alabama, United States
Apex Clinical Trials
Birmingham, Alabama, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Gastrointestinal Bioscience
Los Angeles, California, United States
Paramount Medical Specialty
Montebello, California, United States
Capital Gastroenterology Consultants Medical Group
Sacramento, California, United States
Clinical Applications Laboratories Inc.
San Diego, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
University of Colorado Health Sciences Center
Aurora, Colorado, United States
Gastroenterology of the Rockies
Lafayette, Colorado, United States
Rocky Mountain Gastroenterology Associates P.L.L.C.
Lakewood, Colorado, United States
Arapahoe Gastroenterology Associates P.C
Littleton, Colorado, United States
South Denver Gastroenterology
Lone Tree, Colorado, United States
Lynn Institute of Pueblo
Pueblo, Colorado, United States
Gastroenterology Center of Connecticut, P.C.
Hamden, Connecticut, United States
University of Florida
Gainesville, Florida, United States
University of Florida, Jacksonville
Jacksonville, Florida, United States
East Coast Institute for Research
Jacksonville, Florida, United States
Borland-Groover Clinic
Jacksonville, Florida, United States
Osler Clinical Research
Melbourne, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
United Medical Research Institute
New Smyrna Beach, Florida, United States
Compass Research LLC
Orlando, Florida, United States
Internal Medicine Specialists
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
West Wind'r Research & Development, LLC
Tampa, Florida, United States
Shafran Gastroenterology Center
Winter Park, Florida, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, United States
Southeast Regional Research Group
Columbus, Georgia, United States
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, United States
Digestive Research Associates
Newnan, Georgia, United States
St. Joseph's/Candler Health System
Savannah, Georgia, United States
DLW Research System
Snellville, Georgia, United States
Carle Clinic Association P.C.
Urbana, Illinois, United States
Digestive & Liver Consultants
Clive, Iowa, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
University Of Kansas
Kansas City, Kansas, 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
University of Maryland Medical Group
Baltimore, Maryland, United States
Metropolitan Gastroenterology Group, P.C.
Chevy Chase, Maryland, United States
Shah Associates
Prince Frederick, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston Medical Center
Boston, Massachusetts, United States
The Center for Clinical Studies
Dearborn, Michigan, United States
Center for Digestive Health
Troy, Michigan, United States
Gastroenterology Associates of Western Michigan, P.L.C.
Wyoming, Michigan, United States
Minnesota Gastroenterology, P.A.
Plymouth, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Truman Medical Center
Kansas City, Missouri, United States
Center for Digestive and Liver Diseases, Inc.
Mexico, Missouri, United States
Washington University
St Louis, Missouri, United States
St. Louis Center for Clinical Research
St Louis, Missouri, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Affiliates in Gastroenterology PA
Morristown, New Jersey, United States
University of Medicine and Dentistry of New Jersey-NJMS
New Brunswick, New Jersey, United States
The Gastroenterology Group of South Jersey
Vineland, New Jersey, United States
Hepatobiliary Associates of New York
Bayside, New York, United States
Digestive Health Physician
Cheektowaga, New York, United States
Long Island Clinical Research Associates
Great Neck, New York, United States
Long Island Gastroenterology Group, P.C.
Merrick, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Present Chapman Marion Steinlauf MD PC
New York, New York, United States
Kim, Chung MD (Private Practice)
Pittsford, New York, United States
University of Rochester
Rochester, New York, United States
Long Island Digestive Disease Consultants
Setauket, New York, United States
SUNY Stony Brook University Medical Center
Stony Brook, New York, United States
Syracuse Gastroenterological Associates
Syracuse, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Charlotte Gastroentology and Hepatology, P.L.L.C
Charlotte, North Carolina, United States
Northwest Piedmont Clinical Research, Inc.
Elkin, North Carolina, United States
Burke Research Associates
Morganton, North Carolina, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States
Dayton Science Institute
Dayton, Ohio, United States
Options Health Research
Tulsa, Oklahoma, United States
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, United States
University of Pittsburgh Medical Center - Cancer Centers
Pittsburgh, Pennsylvania, United States
Medical University Of SC CAR
Charleston, South Carolina, United States
Gastroenterology Center of the MidSouth, PC
Germantown, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Austin Gastroenterology, PA
Austin, Texas, United States
Bayou City Research, Ltd.
Houston, Texas, United States
Baylor College Of Medicine
Houston, Texas, United States
Gastroenterology Consultants
Houston, Texas, United States
Jacon Medical Research Associates
Houston, Texas, United States
Digestive Health Center
Pasadena, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, United States
Stone Oak Research Foundation
San Antonio, Texas, United States
Digestive Health Specialists of Tyler
Tyler, Texas, United States
Granite Peaks Gastroenterology
Sandy City, Utah, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Gastroenterology Associates of Northern Virginia
Fairfax, Virginia, United States
Digestive and Liver Disease Specialist Ltd
Norfolk, Virginia, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Puget Sound Medical Research
Edmonds, Washington, United States
Pharmaseek, LLC
Madison, Wisconsin, 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
Royal University Hospital
Saskatoon, Saskatchewan, Canada
Pharmaseek, LLC
Ponce, , Puerto Rico
Countries
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References
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Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.
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, Rosario M. Comparison of the ELISA and ECL Assay for Vedolizumab Anti-drug Antibodies: Assessing the Impact on Pharmacokinetics and Safety Outcomes of the Phase 3 GEMINI Trials. AAPS J. 2020 Nov 16;23(1):3. doi: 10.1208/s12248-020-00518-0.
Okamoto H, Dirks NL, Rosario M, Hori T, Hibi T. Population pharmacokinetics of vedolizumab in Asian and non-Asian patients with ulcerative colitis and Crohn's disease. Intest Res. 2021 Jan;19(1):95-105. doi: 10.5217/ir.2019.09167. Epub 2020 Jul 10.
Loftus EV Jr, Sands BE, Colombel JF, Dotan I, Khalid JM, Tudor D, Geransar P. Sustained Corticosteroid-Free Clinical Remission During Vedolizumab Maintenance Therapy in Patients with Ulcerative Colitis on Stable Concomitant Corticosteroids During Induction Therapy: A Post Hoc Analysis of GEMINI 1. Clin Exp Gastroenterol. 2020 Jun 11;13:211-220. doi: 10.2147/CEG.S248597. eCollection 2020.
Dulai PS, Singh S, Vande Casteele N, Meserve J, Winters A, Chablaney S, Aniwan S, Shashi P, Kochhar G, Weiss A, Koliani-Pace JL, Gao Y, Boland BS, Chang JT, Faleck D, Hirten R, Ungaro R, Lukin D, Sultan K, Hudesman D, Chang S, Bohm M, Varma S, Fischer M, Shmidt E, Swaminath A, Gupta N, Rosario M, Jairath V, Guizzetti L, Feagan BG, Siegel CA, Shen B, Kane S, Loftus EV Jr, Sandborn WJ, Sands BE, Colombel JF, Lasch K, Cao C. Development and Validation of Clinical Scoring Tool to Predict Outcomes of Treatment With Vedolizumab in Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2020 Dec;18(13):2952-2961.e8. doi: 10.1016/j.cgh.2020.02.010. Epub 2020 Feb 13.
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.
Sandborn WJ, Colombel JF, Panaccione R, Dulai PS, Rosario M, Cao C, Barocas M, Lasch K. Deep Remission With Vedolizumab in Patients With Moderately to Severely Active Ulcerative Colitis: A GEMINI 1 post hoc Analysis. J Crohns Colitis. 2019 Feb 1;13(2):172-181. doi: 10.1093/ecco-jcc/jjy149.
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.
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.
Feagan BG, Rubin DT, Danese S, Vermeire S, Abhyankar B, Sankoh S, James A, Smyth M. Efficacy of Vedolizumab Induction and Maintenance Therapy in Patients With Ulcerative Colitis, Regardless of Prior Exposure to Tumor Necrosis Factor Antagonists. Clin Gastroenterol Hepatol. 2017 Feb;15(2):229-239.e5. doi: 10.1016/j.cgh.2016.08.044. Epub 2016 Sep 14.
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.
Other Identifiers
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U1111-1156-8422
Identifier Type: REGISTRY
Identifier Source: secondary_id
2008-002782-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NL25207.096.08
Identifier Type: REGISTRY
Identifier Source: secondary_id
CTRI/2009/091/000128
Identifier Type: REGISTRY
Identifier Source: secondary_id
NMRR-08-1046-2201
Identifier Type: REGISTRY
Identifier Source: secondary_id
C13006CTIL
Identifier Type: OTHER
Identifier Source: secondary_id
09/H1102/66
Identifier Type: REGISTRY
Identifier Source: secondary_id
C13006
Identifier Type: -
Identifier Source: org_study_id
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