The purpose of this trial is to evaluate natalizumab in individuals with moderately to severely active Crohn’s Disease.

Condition	Treatment or Intervention	Phase
Crohn's Disease	Drug: Antegren(TM) (natalizumab)	Phase III

Further Study Details: 

Expected Total Enrollment:  462

Natalizumab is a humanized monoclonal antibody currently being investigated as a potential treatment for Crohn’s disease. It is believed to work by preventing white blood cells from moving from the blood stream into the bowel tissue. These cells are thought to cause damage to the bowel, leading to the symptoms of Crohn’s disease. Elan Pharmaceuticals is currently sponsoring an international study evaluating the safety and efficacy of natalizumab in individuals with moderately to severely active Crohn’s disease. Individuals with Crohn’s disease will be randomly assigned to receive either placebo (an inactive solution) or natalizumab by intravenous infusion (this means putting it directly into a vein in the arm). There will be a one out of two chance of receiving natalizumab and a one out of two chance of receiving placebo. Participants in the study will receive several infusions of natalizumab or placebo at 4-week intervals. Eligible participants will then have the opportunity to enroll into an extension study that will allow all participants to receive natalizumab. For those patients who do not enroll into the extension study, the total participation in this study will last for approximately 22 weeks.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

• Males and females 18 years of age or older
• Diagnosis of Crohn’s disease for at least 6 months
• Females must not be pregnant or breastfeeding
• Must not have previously taken natalizumab
• Use of some other Crohn’s disease medications is permitted, but will be closely supervised

Arizona
      Advanced Clinical Therapeutics, Tucson,  Arizona,  85712,  United States
      Harmony Clinical Research, Oro Valley,  Arizona,  85739,  United States
California
      UCSF / Mt. Zion IBD Center, San Francisco,  California,  94115,  United States
      Cedars-Sinai Medical Center, Los Angeles,  California,  90048,  United States
      Shared Medical Research Foundation, Tarzana,  California,  91356,  United States
      Digestive Diseases Foundation, Los Angeles,  California,  90067,  United States
      Advanced Clinical Research Institute, Anaheim,  California,  92801,  United States
      Community Clinical Trials, Orange,  California,  92868,  United States
      David Geffen School of Medicine at UCLA, Division of Digestive Diseases, Los Angeles,  California,  90092-7019,  United States
Colorado
      Arapahoe Gastroenterology, Littleton,  Colorado,  80120,  United States
      Lynn Institute of the Rockies, Colorado Springs,  Colorado,  80909,  United States
      Rocky Mountain Gastroenterology, Golden,  Colorado,  80215,  United States
Connecticut
      Center for Medical Research, LLC, Manchester,  Connecticut,  06040,  United States
District of Columbia
      Morowitz, Marion, Laessing, Shocket, Bashir, Steinberg, Salcedo, Washington,  District of Columbia,  20010,  United States
Florida
      Shafran Gastroenterology Center, Winterpark,  Florida,  32789,  United States
      Malcolm Randall VA Medical Center, Gainesville,  Florida,  32608,  United States
      Waterside Clinical Research Services, Inc., West Palm Beach,  Florida,  33407,  United States
      Borland Groover Clinic, Jacksonville,  Florida,  32256,  United States
      Miami Research Associates, Inc., Miami,  Florida,  33173,  United States
Georgia
      Atlanta Gastroenterology Associates, Atlanta,  Georgia,  30342,  United States
Illinois
      University of Chicago Hospitals, Chicago,  Illinois,  60637,  United States
Indiana
      Indianapolis Gastroenterology Research Foundation, Indianapolis,  Indiana,  46227,  United States
      Outpatient Clinical Research Facility, Indianapolis,  Indiana,  46202-5250,  United States
Kentucky
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536,  United States
      University of Louisville, Louisville,  Kentucky,  40202,  United States
Louisiana
      Drug Research Service, Inc., Metairie,  Louisiana,  70001,  United States
Maryland
      Metropolitan Gastroenterology Group, PC / Chevy Chase Clinical Research, Chevy Chase,  Maryland,  20815,  United States
Minnesota
      Minnesota Gastroenterology, P.A., Plymouth,  Minnesota,  55446,  United States
      Mayo Clinic, Rochester,  Minnesota,  55905,  United States
New York
      Long Island Clinical Research Associates, LLP, Great Neck,  New York,  11021,  United States
      Rochester Institute for Digestive Diseases and Sciences, Inc., Rochester,  New York,  14607,  United States
      New York Center for Clinical Research, Lake Success,  New York,  11042,  United States
      Mount Sinai School of Medicine, New York,  New York,  10028,  United States
North Carolina
      Asheville Gastroenterology Associates, Asheville,  North Carolina,  28801,  United States
      Charlotte Gastroenterology & Hepatology, PLLC., Charlotte,  North Carolina,  28207,  United States
      Wake Forest University School of Medicine, Winston Salem,  North Carolina,  27012,  United States
      Wake Research Associates, Raleigh,  North Carolina,  27612,  United States
      University of North Carolina, Chapel Hill,  North Carolina,  27599,  United States
Ohio
      Consultants for Clinical Research, Inc., Cincinnati,  Ohio,  45219,  United States
      Cleveland Clinic Foundation, Cleveland,  Ohio,  44195,  United States
Oklahoma
      Oklahoma Foundation for Digestive Research, Oklahoma City,  Oklahoma,  73104,  United States
      Lynn Health Science Institute, Oklahoma City,  Oklahoma,  73112,  United States
      Oklahoma Gastroenterology Associates, Tulsa,  Oklahoma,  74104,  United States
Pennsylvania
      Allegheny Center for Digestive Health, Pittsburgh,  Pennsylvania,  15212,  United States
      Milton S. Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
Rhode Island
      Gastroenterology Associates, Providence,  Rhode Island,  02904,  United States
South Carolina
      Medical University of South Carolina - Digestive Disease Center, Charleston,  South Carolina,  29425,  United States
Tennessee
      Gastroenterology Center of the Midsouth, P.C., Memphis,  Tennessee,  38120,  United States
      Nashville Medical Research Institute, Nashville,  Tennessee,  37205,  United States
      Southeastern Clinical Research, Chattanooga,  Tennessee,  37403,  United States
      Summit Research Solutions, Memphis,  Tennessee,  38120,  United States
Texas
      Atilla Ertan, MD, PA, Houston,  Texas,  77030,  United States
      Gastroenterology Clinic of San Antonio, P.A., San Antonio,  Texas,  78229,  United States
      Austin Gastroenterology, PA, Austin,  Texas,  78745,  United States
Utah
      Wasatch Clinical Research, Salt Lake City,  Utah,  84107,  United States
Virginia
      Gastroenterology Associates of Tidewater, Chesapeake,  Virginia,  23320,  United States
      Internal Medicine Associates, Danville,  Virginia,  24541,  United States
      UVA Health System, Charlottesville,  Virginia,  22908,  United States
      McGuire DVAMC GI (111N), Richmond,  Virginia,  23249,  United States
Washington
      Tacoma Digestive Disease Research Center, Tacoma,  Washington,  98405,  United States
      Virginia Mason Medical Center, Seattle,  Washington,  98101,  United States
Wisconsin
      Aurora Helath Care, Milwaukee,  Wisconsin,  53215,  United States
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
Canada
      Chauq Hopital Du St. Sacrement, Quebec,  G1S 4L8,  Canada
Canada, Alberta
      University of Calgary, Calgary,  Alberta,  T2N 4N1,  Canada
      GI Research, Edmonton,  Alberta,  T5H 4B9,  Canada
      University of Alberta, Edmonton,  Alberta,  T6G 2C8,  Canada
Canada, British Columbia
      Liver and Intestinal Research Centre, Vancouver,  British Columbia,  V5Z 1H2,  Canada
      St. Paul's Hospital, Vancouver,  British Columbia,  V6Z 1Y6,  Canada
Canada, Manitoba
      Health Sciences Center, Winnipeg,  Manitoba,  R3A 1R9,  Canada
Canada, Nova Scotia
      Queen Elizabeth II Science Center, Halifax,  Nova Scotia,  B3H 1V7,  Canada
Canada, Ontario
      Mount Sinai Hospital, Toronto,  Ontario,  M5G 1X5,  Canada
      Sunnybrook & Women's College Health Sciences Center, Toronto,  Ontario,  M4N 3M5,  Canada
      McMaster University Medical Centre, Hamilton,  Ontario,  L8N 3Z5,  Canada
Canada, Quebec
      Montreal General Hospital, Montreal,  Quebec,  H3G 1A4,  Canada

Study ID Numbers:  ELN100226-CD307
Record last reviewed:  December 2004
Last Updated:  December 17, 2004
Record first received:  March 1, 2004
ClinicalTrials.gov Identifier:  NCT00078611
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08