Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
GEMINI III
A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction of Clinical Response and Remission by Vedolizumab in Patients With Moderate to Severe Crohn's Disease
4 other identifiers
interventional
416
2 countries
41
Brief Summary
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2010
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
July 21, 2014
CompletedJuly 21, 2014
June 1, 2014
1.3 years
October 18, 2010
June 19, 2014
June 19, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation
Clinical remission is defined as a Crohn's Disease Activity Index (CDAI) score ≤ 150 points. The CDAI is used to quantify the symptoms of patients with Crohn's disease and consists of eight factors, each summed after adjustment with a weighting factor. The components of the CDAI are: * Number of liquid or soft stools each day for 7 days; * Abdominal pain (graded from 0-3 on severity) each day for 7 days; * General well-being, subjectively assessed from 0 (well) to 4 (terrible) each day for 7 days; * Presence of complications; * Taking Lomotil or opiates for diarrhea; * Presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); * Hematocrit of \< 0.47 in men and \< 0.42 in women; * Percentage deviation from standard weight. The total score ranges from 0 to approximately 600 and with higher scores indicating greater disease activity. All participants who prematurely discontinued for any reason were considered as not achieving clinical remission.
Week 6
Secondary Outcomes (7)
Percentage of Participants in Clinical Remission at Week 6 in the Overall Population
Week 6
Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation
Week 10
Percentage of Participants in Clinical Remission at Week 10 in the Overall Population
Week 10
Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population
Week 6 and Week 10
Percentage of Participants With Sustained Clinical Remission in the Overall Population
Week 6 and Week 10
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORParticipants received placebo intravenous infusion at Weeks 0, 2 and 6.
Vedolizumab
EXPERIMENTALParticipants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
Interventions
Vedolizumab for intravenous infusion
Eligibility Criteria
You may qualify if:
- Age 18 to 80
- 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
You may not qualify if:
- Evidence of abdominal abscess at the initial screening visit
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Gastroenterology of the Rockies
Lafayette, Colorado, 80026, United States
Gastroenterology Center of Connecticut P.C.
Hamden, Connecticut, 65180, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
Gastroenterology Associates of Central Georgia
Macon, Georgia, 31201, United States
Atlanta Gastroenterology Specialist PC
Suwanee, Georgia, 30024, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Cotton O'Neil Digestive Health Center
Topeka, Kansas, 66606, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536, United States
University Of Louisville
Louisville, Kentucky, 40402, United States
Gastroenterology Associates
Baton Rouge, Louisiana, 70809, United States
Gastroenterology Research of New Orleans
Hammond, Louisiana, 70403, United States
Metropolitan Gastroenterology Group P.C.
Chevy Chase, Maryland, 20815, United States
Mid-Atlantic Medical Research Center
Hollywood, Maryland, 20636, United States
Massachusetts General Hospital Crohn's and Colitis Center
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197, United States
Minnesota Gastroenterology P.A.
Plymouth, Minnesota, 55446, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University
St Louis, Missouri, 63110, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Long Island Clinical Research Associates
Great Neck, New York, 11021, United States
New York Presbyterian Hospital
New York, New York, 10021, United States
University of Rochester
Rochester, New York, 14642, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Charlotte Gastroenterology and Hepatology P.L.L.C
Charlotte, North Carolina, 28207, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, 45219, United States
Options Health Research
Tulsa, Oklahoma, 74104, United States
The Oregon Clinic-West Hills Gastroenterology
Portland, Oregon, 97225, United States
Consultants in Gastroenterology
Columbia, South Carolina, 29203, United States
Gastroenterology Center of the MidSouth PC
Germantown, Tennessee, 38138, United States
Gastroenterology Clinic of San Antonio
San Antonio, Texas, 78229, United States
Digestive Health Specialists of Tyler
Tyler, Texas, 75701, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
University of Washington School of Medicine
Seattle, Washington, 98195, United States
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, 53215, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Zeidler Ledcor Center-Univerisity of Alberta
Edmonton, Alberta, T6G2X8, Canada
Related Publications (6)
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.
PMID: 30615117DERIVEDFeagan 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.
PMID: 30203005DERIVEDFeagan 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.
PMID: 29857145DERIVEDColombel 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.
PMID: 26893500DERIVEDRosario 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.
PMID: 25996351DERIVEDSands 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.
PMID: 24859203DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Millennium Pharmaceuticals Inc.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Millennium Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 19, 2010
Study Start
November 1, 2010
Primary Completion
February 1, 2012
Study Completion
April 1, 2012
Last Updated
July 21, 2014
Results First Posted
July 21, 2014
Record last verified: 2014-06