The purpose of this study is to determine the safety, tolerability, and efficacy of natalizumab in individuals diagnosed with active Crohn’s Disease that are not in remission (CDAI greater than/equal to 150) and are currently taking Remicade. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn’s disease.

Patients who complete this study may be eligible for long-term natalizumab therapy via extension protocol ELN100226-351.

Condition	Treatment or Intervention	Phase
Crohn's Disease	Drug: Natalizumab	Phase II

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

Criteria

• Male and female patients at least 18 years of age with at least a six-month history of Crohn’s disease and who are currently receiving Remicade and are not in remission (CDAI greater than/equal to 150)
• Women must not be breastfeeding or pregnant, and must not become pregnant during the study.

Florida
      Borland Groover Clinic, Jacksonville,  Florida,  32223,  United States
      Digestive Disease Associates, Gainesville,  Florida,  32605,  United States
Georgia
      Atlanta Gastroenterology Associates, Atlanta,  Georgia,  30342,  United States
Kentucky
      University of Kentucky Medical Center, Lexington,  Kentucky,  40536,  United States
Massachusetts
      Massachusetts General Hospital, Boston,  Massachusetts,  02114,  United States
Montana
      Mercury Street Medical, Butte,  Montana,  59701,  United States
New York
      Long Island Clinical Research Associates, LLP, Great Neck,  New York,  11021,  United States
North Carolina
      Asheville Gastroenterology, Asheville,  North Carolina,  28801,  United States
      Boice-Willis Clinic, Rocky Mount,  North Carolina,  27804,  United States
      Wake Research Associates, Raleigh,  North Carolina,  27612,  United States
South Carolina
      Columbia Gastroenterology Associates, Columbia,  South Carolina,  29203,  United States
Tennessee
      Gastroenterology Center of the MidSouth, Memphis,  Tennessee,  38120,  United States
      Memphis Gastroenterology Group, Memphis,  Tennessee,  38120,  United States
Texas
      Austin Gastroenterology, Austin,  Texas,  78745,  United States
Virginia
      Gastroenterology Consultants, Virginia Beach,  Virginia,  23455,  United States
      Internal Medicine Associates, Danville,  Virginia,  24541,  United States
Washington
      Digestive Health Specialists, Tacoma,  Washington,  98405,  United States
      Virginia Mason Medical Center, Seattle,  Washington,  98101,  United States

Study ID Numbers:  CD306
Record last reviewed:  December 2004
Last Updated:  December 17, 2004
Record first received:  March 4, 2003
ClinicalTrials.gov Identifier:  NCT00055536
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08