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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


Phase 3
18 Years
80 Years
Not Enrolling
Both
Crohn's Disease

Thank you

Trial Information

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


Inclusion Criteria:



1. Age 18 to 80

2. Diagnosis of moderately to severely active Crohn's disease

3. CD involvement of the ileum and/or colon

4. 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

5. May be receiving a therapeutic dose of conventional therapies for IBD as defined by
the protocol

Exclusion Criteria

1. Evidence of abdominal abscess at the initial screening visit

2. Extensive colonic resection, subtotal or total colectomy

3. History of >3 small bowel resections or diagnosis of short bowel syndrome

4. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine

5. Have received non permitted IBD therapies within either 30 or 60 days, depending on
the medication, as stated in the protocol

6. Chronic hepatitis B or C infection

7. Active or latent tuberculosis

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Proportion of patients in clinical remission

Outcome Time Frame:

Week 6 & 52

Safety Issue:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

C13007

NCT ID:

NCT00783692

Start Date:

December 2008

Completion Date:

May 2012

Related Keywords:

  • Crohn's Disease
  • Crohn Disease

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Mayo ClinicRochester, Minnesota  55905
Medical College of WisconsinMilwaukee, Wisconsin  53226
Rush University Medical CenterChicago, Illinois  60612-3824
Boston Medical CenterBoston, Massachusetts  02118
Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Northwest Gastroenterology AssociatesBellevue, Washington  98004
Wisconsin Center for Advanced ResearchMilwaukee, Wisconsin  53207
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Hunter Holmes McGuire VA Medical CenterRichmond, Virginia  23249
University of Colorado Health Sciences CenterDenver, Colorado  80262
University of FloridaGainesville, Florida  32610-0277
University of RochesterRochester, New York  14642
University of Chicago Medical CenterChicago, Illinois  60637
University of LouisvilleLouisville, Kentucky  40202
University of Florida, JacksonvilleJacksonville, Florida  32209
Washington UniversitySt. Louis, Missouri  63110
Atlanta Gastroenterology AssociatesAtlanta, Georgia  
University of Kentucky Medical CenterLexington, Kentucky  40536-0093
New York Presbyterian HospitalNew York, New York  10021
St. Louis Center for Clinical ResearchSt. Louis, Missouri  63128
Truman Medical CenterKansas City, Missouri  64108
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
University of Virginia Health SystemCharlottesville, Virginia  22903
Wake Forest University Baptist Medical CenterWinston-Salem, North Carolina  27157
University Of Miami Miller School Of MedicineMiami, Florida  33010
University of South FloridaTampa, Florida  33612
South Denver GastroenterologyEnglewood, Colorado  
Alamo Medical ResearchSan Antonio, Texas  78215
Borland-Groover ClinicJacksonville, Florida  32256
Minnesota Gastroenterology, P.A.Plymouth, Minnesota  55446
Austin Gastroenterology, PaAustin, Texas  78705
Gastroenterology Clinic Of San AntonioSan Antonio, Texas  78229
Options Health ResearchTulsa, Oklahoma  74104
Gastroenterology Center of the MidSouth, PCGermantown, Tennessee  37138
Internal Medicine SpecialistsOrlando, Florida  32806
Apex Clinical TrialsBirmingham, Alabama  35234
Gastrointestinal BioscienceLos Angeles, California  90067
Paramount Medical SpecialtyMontebello, California  90640
Capital Gastroenterology Consultants Medical GroupSacramento, California  95815
Clinical Applications Laboratories Inc.San Diego, California  92103
Desta Digestive Disease Medical CenterSan Diego, California  92114
Rocky Mountain Clinical Research, LLCGolden, Colorado  80401
Gastroenterology of the RockiesLafayette, Colorado  80026
Arapahoe Gastroenterology Associates P.C.Littleton, Colorado  80120
Lynn Institute of PuebloPueblo, Colorado  81007
Connecticut Gastroenterology InstituteBristol, Connecticut  06010
Gastroenterology Center of Connecticut, P.C.Hamden, Connecticut  06518
East Coast Institute for ResearchJacksonville, Florida  32223
Center for Advanced GastroenterologyMaitland, Florida  32751
Osler Clinical ResearchMelbourne, Florida  32901
United Medical Research InstituteNew Smyrna Beach, Florida  32168
Compass Research LLCOrlando, Florida  32806
West Wind'r Research & Development, LLCTampa, Florida  33607
Shafran Gastroenterology CenterWinter Park, Florida  32789
Southeast Regional Research GroupColumbus, Georgia  31904
Atlanta Center for Gastroenterology, P.C.Decatur, Georgia  30033
Gastroenterology Associates of Central GeorgiaMacon, Georgia  31201
Digestive Research AssociatesNewnan, Georgia  30263
St. Joseph's/Candler Health SystemSavannah, Georgia  31405
DLW Research SystemSnellville, Georgia  30039
Carle Clinic Association P.C.Urbana, Illinois  58150
Indianapolis Gastroenterology & Hepatology, Inc.- ARCIndianapolis, Indiana  46237
Iowa Digestive Disease CenterClive, Iowa  50325
Digestive & Liver ConsultantsClive, Iowa  50325
University Of KansasKansas City, Kansas  66160
Cotton O'Neil Digestive Health CenterTopeka, Kansas  66606
Gastroenterology AssociatesBaton Rouge, Louisiana  70809
Metropolitan Gastroenterology Group, P.C.Chevy Chase, Maryland  20815
Shah AssociatesPrince Frederick, Maryland  20678
The Center for Clinical StudiesDearborn, Michigan  48124
Center for Digestive HealthTroy, Michigan  48098
Gastroenterology Associates of Western Michigan, P.L.C.Wyoming, Michigan  49519
Digestive Health SpecialistsTupelo, Mississippi  38801
Center for Digestive and Liver Diseases, Inc.Mexico, Missouri  65265
Affiliates in Gastroenterology PAMorristown, New Jersey  07960
University of Medicine and Dentistry of New Jersey-NJMSNew Brunswick, New Jersey  08903
The Gastroenterology Group of South JerseyVineland, New Jersey  08360
Hepatobiliary Associates of New YorkBayside, New York  11358
Digestive Health PhysicianCheektowaga, New York  14225
Long Island Clinical Research AssociatesGreat Neck, New York  11021
Long Island Gastroenterology Group, P.C.Merrick, New York  11566
Present Chapman Marion Steinlauf MD PCNew York, New York  10028
Kim, Chung MD (Private Practice)Pittsford, New York  14534
Long Island Digestive Disease ConsultantsSetauket, New York  11733
SUNY Stony Brook University Medical CenterStonybrook, New York  11794
Syracuse Gastroenterological AssociatesSyracuse, New York  13210
Asheville Gastroenterology Associates, P.A.Asheville, North Carolina  28801
Charlotte Gastroentology and Hepatology, P.L.L.CCharlotte, North Carolina  28207
Northwest Piedmont Clinical Research, Inc.Elkin, North Carolina  28621
Burke Research AssociatesMorganton, North Carolina  28655
Consultants for Clinical Research Inc.Cincinnati, Ohio  45219
Dayton Science InstituteDayton, Ohio  45415
The Oregon Clinic-West Hills GastroenterologyPortland, Oregon  97225
University of Pittsburgh Medical Center - Cancer CentersPittsburgh, Pennsylvania  15213
Medical University Of SC CARCharleston, South Carolina  29425
Consultants in GastroenterologyColumbia, South Carolina  29203
Bayou City Research, Ltd.Houston, Texas  77024
Gastroenterology ConsultantsHouston, Texas  77034
Jacon Medical Research AssociatesHouston, Texas  77090
Digestive Health CenterPasadena, Texas  77504
Stone Oak Research FoundationSan Antonio, Texas  78258
Digestive Health Specialists of TylerTyler, Texas  75701
Granite Peaks GastroenterologySandy, Utah  84094
Gastroenterology Associates of Northern VirginiaFairfax, Virginia  22031
Digestive and Liver Disease Specialist Ltd.Norfolk, Virginia  23502
Puget Sound Medical ResearchEdmonds, Washington  98026
Pharmaseek, LLCMadison, Wisconsin  53717