The purpose of this study is to determine the safety and tolerability of natalizumab in adolescents (ages 12-17) diagnosed with moderately to severely active Crohn’s disease (CD). 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 ELN100226-352.

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

Ages Eligible for Study:  12 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

Male and female patients, 12-17 years of age, who have at least a six-month history of Crohn’s disease and who are currently experiencing moderately to severely active Crohn’s disease. Females must not be breastfeeding or pregnant, and must not become pregnant during the study.

California
      Cedars-Sinai IBD Center, Los Angeles,  California,  90048,  United States
Connecticut
      Connecticut Children’s Medical Center, Hartford,  Connecticut,  06106,  United States
Florida
      Miami Research Associates, Miami,  Florida,  33173,  United States
Maryland
      Johns Hopkins University School of Medicine, Baltimore,  Maryland,  21287-2631,  United States
Massachusetts
      Mass General Hospital for Children, Pediatric GI & Nutrition, Boston,  Massachusetts,  02114,  United States
      The Children’s Hospital, Boston,  Massachusetts,  02115,  United States
New York
      University of Rochester, Rochester,  New York,  14642,  United States
North Carolina
      Carolina Digestive Health Associates, Charlotte,  North Carolina,  28211,  United States
Pennsylvania
      Children’s Hospital of Philadelphia, Philadelphia,  Pennsylvania,  19104-4399,  United States
      Hershey Medical Center, Hershey,  Pennsylvania,  17033,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
United Kingdom
      Royal Free Medical School, London,  NWS 2QG,  United Kingdom
      Royal Hospital for Sick Children, Edinburgh,  EH9 1LF,  United Kingdom

Study ID Numbers:  CD305
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  February 26, 2003
ClinicalTrials.gov Identifier:  NCT00055367
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08