Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease (GEMINI II)
This study has been completed.
Sponsor:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00783692
First received: October 31, 2008
Last updated: April 8, 2013
Last verified: April 2013
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Purpose
This multicenter, phase 3, randomized, blinded, placebo-controlled study in patients with moderately to severely active CD comprises two phases:
- The Induction Phase, designed to establish the efficacy and safety of vedolizumab (MLN0002) for the induction of clinical response and remission
- The Maintenance Phase, designed to establish the efficacy and safety of vedolizumab(MLN0002) for the maintenance of clinical response and remission.
| Condition | Intervention | Phase |
|---|---|---|
|
Crohn's Disease |
Drug: vedolizumab Other: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Phase 3, Randomized, Placebo-Controlled, Blinded, Multicenter Study of the Induction and Maintenance of Clinical Response and Remission by Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
Further study details as provided by Millennium Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Proportion of patients in clinical remission [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]
- Proportion of patients with enhanced clinical response [ Time Frame: At 6 weeks ] [ Designated as safety issue: No ]A greater than or equal to 100-point decrease in Crohn's Disease Activity Index (CDAI) score from baseline (Week 0)
Secondary Outcome Measures:
- Proportion of patients with enhanced clinical response [ Time Frame: Week 6 & 52 ] [ Designated as safety issue: No ]
| Enrollment: | 1116 |
| Study Start Date: | December 2008 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
Experimental: 1
|
Drug: vedolizumab
Vedolizumab (MLN0002) is given at weeks 0, 2, 6 and then at 4-week intervals, or 8-week intervals for up to one year.
Other Name: MLN0002
|
|
Placebo Comparator: 2
Placebo add-on Comparator
|
Other: Placebo
The placebo infusion (IV) will be composed of normal saline. This is given at weeks 0, 2, 6 and then at 4-weekly intervals for up to one year.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease
- CD 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 IBD as defined by the protocol
Exclusion Criteria
- 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 IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- Chronic hepatitis B or C infection
- Active or latent tuberculosis
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783692
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| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35233 | |
| Apex Clinical Trials | |
| Birmingham, Alabama, United States, 35234 | |
| United States, California | |
| Gastrointestinal Bioscience | |
| Los Angeles, California, United States, 90067 | |
| Paramount Medical Specialty | |
| Montebello, California, United States, 90640 | |
| Capital Gastroenterology Consultants Medical Group | |
| Sacramento, California, United States, 95815 | |
| Clinical Applications Laboratories Inc. | |
| San Diego, California, United States, 92103 | |
| Desta Digestive Disease Medical Center | |
| San Diego, California, United States, 92114 | |
| United States, Colorado | |
| University of Colorado Health Sciences Center | |
| Aurora, Colorado, United States, 80045 | |
| Rocky Mountain Clinical Research, LLC | |
| Golden, Colorado, United States, 80401 | |
| Gastroenterology of the Rockies | |
| Lafayette, Colorado, United States, 80026 | |
| Arapahoe Gastroenterology Associates P.C. | |
| Littleton, Colorado, United States, 80120 | |
| South Denver Gastroenterology | |
| Lone Tree, Colorado, United States, 80124 | |
| Lynn Institute of Pueblo | |
| Pueblo, Colorado, United States, 81007 | |
| United States, Connecticut | |
| Connecticut Gastroenterology Institute | |
| Bristol, Connecticut, United States, 06010 | |
| Gastroenterology Center of Connecticut, P.C. | |
| Hamden, Connecticut, United States, 06518 | |
| United States, Florida | |
| University of Florida | |
| Gainesville, Florida, United States, 32608 | |
| University of Florida, Jacksonville | |
| Jacksonville, Florida, United States, 32209 | |
| Borland-Groover Clinic | |
| Jacksonville, Florida, United States, 32256 | |
| East Coast Institute for Research | |
| Jacksonville, Florida, United States, 32223 | |
| Center for Advanced Gastroenterology | |
| Maitland, Florida, United States, 32751 | |
| Osler Clinical Research | |
| Melbourne, Florida, United States, 32901 | |
| University of Miami Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| United Medical Research Institute | |
| New Smyrna Beach, Florida, United States, 32168 | |
| Internal Medicine Specialists | |
| Orlando, Florida, United States, 32806 | |
| Compass Research LLC | |
| Orlando, Florida, United States, 32806 | |
| West Wind'r Research & Development, LLC | |
| Tampa, Florida, United States, 33607 | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| Shafran Gastroenterology Center | |
| Winter Park, Florida, United States, 32789 | |
| United States, Georgia | |
| Atlanta Gastroenterology Associates | |
| Atlanta, Georgia, United States, 30342 | |
| Southeast Regional Research Group | |
| Columbus, Georgia, United States, 31904 | |
| Atlanta Center for Gastroenterology, P.C. | |
| Decatur, Georgia, United States, 30033 | |
| Gastroenterology Associates of Central Georgia | |
| Macon, Georgia, United States, 31201 | |
| Digestive Research Associates | |
| Newnan, Georgia, United States, 30263 | |
| St. Joseph's/Candler Health System | |
| Savannah, Georgia, United States, 31405 | |
| DLW Research System | |
| Snellville, Georgia, United States, 30039 | |
| United States, Illinois | |
| Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| Carle Clinic Association P.C. | |
| Urbana, Illinois, United States, 58150 | |
| United States, Indiana | |
| Indianapolis Gastroenterology & Hepatology, Inc.- ARC | |
| Indianapolis, Indiana, United States, 46237 | |
| United States, Iowa | |
| Iowa Digestive Disease Center | |
| Clive, Iowa, United States, 50325 | |
| Digestive & Liver Consultants | |
| Clive, Iowa, United States, 50325 | |
| United States, Kansas | |
| University Of Kansas | |
| Kansas City, Kansas, United States, 66160 | |
| Cotton O'Neil Digestive Health Center | |
| Topeka, Kansas, United States, 66606 | |
| United States, Kentucky | |
| University of Kentucky Medical Center | |
| Lexington, Kentucky, United States, 40536 | |
| University Of Louisville | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Louisiana | |
| Gastroenterology Associates | |
| Baton Rouge, Louisiana, United States, 70809 | |
| United States, Maryland | |
| Metropolitan Gastroenterology Group, P.C. | |
| Chevy Chase, Maryland, United States, 20815 | |
| Shah Associates | |
| Prince Frederick, Maryland, United States, 20678 | |
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Boston Medical Center | |
| Boston, Massachusetts, United States, 02118 | |
| United States, Michigan | |
| The Center for Clinical Studies | |
| Dearborn, Michigan, United States, 48124 | |
| Center for Digestive Health | |
| Troy, Michigan, United States, 48098 | |
| Gastroenterology Associates of Western Michigan, P.L.C. | |
| Wyoming, Michigan, United States, 49519 | |
| United States, Minnesota | |
| Minnesota Gastroenterology, P.A. | |
| Plymouth, Minnesota, United States, 55486 | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Mississippi | |
| Digestive Health Specialists | |
| Tupelo, Mississippi, United States, 38801 | |
| United States, Missouri | |
| Truman Medical Center | |
| Kansas City, Missouri, United States, 64108 | |
| Center for Digestive and Liver Diseases, Inc. | |
| Mexico, Missouri, United States, 65265 | |
| St. Louis Center for Clinical Research | |
| St. Louis, Missouri, United States, 63128 | |
| Washington University | |
| St. Louis, Missouri, United States, 63110 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Affiliates in Gastroenterology PA | |
| Morristown, New Jersey, United States, 07960 | |
| University of Medicine and Dentistry of New Jersey-NJMS | |
| New Brunswick, New Jersey, United States, 08903 | |
| The Gastroenterology Group of South Jersey | |
| Vineland, New Jersey, United States, 08360 | |
| United States, New York | |
| Hepatobiliary Associates of New York | |
| Bayside, New York, United States, 11358 | |
| Digestive Health Physician | |
| Cheektowaga, New York, United States, 14225 | |
| Long Island Clinical Research Associates | |
| Great Neck, New York, United States, 11021 | |
| Long Island Gastroenterology Group, P.C. | |
| Merrick, New York, United States, 11566 | |
| Present Chapman Marion Steinlauf MD PC | |
| New York, New York, United States, 10028 | |
| New York Presbyterian Hospital | |
| New York, New York, United States, 10021 | |
| Kim, Chung MD (Private Practice) | |
| Pittsford, New York, United States, 14534 | |
| University of Rochester | |
| Rochester, New York, United States, 14642 | |
| Long Island Digestive Disease Consultants | |
| Setauket, New York, United States, 11733 | |
| SUNY Stony Brook University Medical Center | |
| Stonybrook, New York, United States, 11794 | |
| Syracuse Gastroenterological Associates | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Asheville Gastroenterology Associates, P.A. | |
| Asheville, North Carolina, United States, 28801 | |
| University of North Carolina at Chapel Hill | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Charlotte Gastroentology and Hepatology, P.L.L.C | |
| Charlotte, North Carolina, United States, 28207 | |
| Northwest Piedmont Clinical Research, Inc. | |
| Elkin, North Carolina, United States, 28621 | |
| Burke Research Associates | |
| Morganton, North Carolina, United States, 28655 | |
| Wake Forest University Baptist Medical Center | |
| Winston Salem, North Carolina, United States, 27157 | |
| United States, Ohio | |
| Consultants for Clinical Research Inc. | |
| Cincinnati, Ohio, United States, 45219 | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Dayton Science Institute | |
| Dayton, Ohio, United States, 45415 | |
| United States, Oklahoma | |
| Options Health Research | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| The Oregon Clinic-West Hills Gastroenterology | |
| Portland, Oregon, United States, 97225 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center - Cancer Centers | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, South Carolina | |
| Medical University Of SC CAR | |
| Charleston, South Carolina, United States, 29425 | |
| Consultants in Gastroenterology | |
| Columbia, South Carolina, United States, 29203 | |
| United States, Tennessee | |
| Gastroenterology Center of the MidSouth, PC | |
| Germantown, Tennessee, United States, 38138 | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Austin Gastroenterology, PA | |
| Austin, Texas, United States, 78705 | |
| Bayou City Research, Ltd. | |
| Houston, Texas, United States, 77024 | |
| Gastroenterology Consultants | |
| Houston, Texas, United States, 77034 | |
| Jacon Medical Research Associates | |
| Houston, Texas, United States, 77090 | |
| Digestive Health Center | |
| Pasadena, Texas, United States, 77504 | |
| Gastroenterology Clinic of San Antonio | |
| San Antonio, Texas, United States, 78229 | |
| Alamo Medical Research | |
| San Antonio, Texas, United States, 78215 | |
| Stone Oak Research Foundation | |
| San Antonio, Texas, United States, 78258 | |
| Digestive Health Specialists of Tyler | |
| Tyler, Texas, United States, 75701 | |
| United States, Utah | |
| Granite Peaks Gastroenterology | |
| Sandy, Utah, United States, 84094 | |
| United States, Virginia | |
| University of Virginia Health System | |
| Charlottesville, Virginia, United States, 22908 | |
| Gastroenterology Associates of Northern Virginia | |
| Fairfax, Virginia, United States, 22031 | |
| Digestive and Liver Disease Specialist Ltd. | |
| Norfolk, Virginia, United States, 23502 | |
| Hunter Holmes McGuire VA Medical Center | |
| Richmond, Virginia, United States, 23249 | |
| United States, Washington | |
| Northwest Gastroenterology Associates | |
| Bellevue, Washington, United States, 98004 | |
| Puget Sound Medical Research | |
| Edmonds, Washington, United States, 98026 | |
| United States, Wisconsin | |
| Pharmaseek, LLC | |
| Madison, Wisconsin, United States, 53717 | |
| Wisconsin Center for Advanced Research | |
| Milwaukee, Wisconsin, United States, 53215 | |
| Medical College Of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Canada, Alberta | |
| GI Research | |
| Edmonton, Alberta, Canada, T5H4B9 | |
| Zeidler Ledcor Center-Univerisity of Alberta | |
| Edmonton, Alberta, Canada, T6G2X8 | |
| Canada, Saskatchewan | |
| Royal University Hospital | |
| Saskatoon, Saskatchewan, Canada, S7N 0W8 | |
| Puerto Rico | |
| Pharmaseek, LLC | |
| Ponce, Puerto Rico, 716 | |
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Investigators
| Study Director: | Medical Monitor | Millennium Pharmaceuticals, Inc. |
More Information
No publications provided
| Responsible Party: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00783692 History of Changes |
| Other Study ID Numbers: | C13007 |
| Study First Received: | October 31, 2008 |
| Last Updated: | April 8, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
ClinicalTrials.gov processed this record on May 19, 2013