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Safety, Tolerability and Effectiveness of Natalizumab in Adolescents With Active Crohn's Disease

Information source: Elan Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Crohn's Disease

Intervention: Natalizumab (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Elan Pharmaceuticals

Summary

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.

Clinical Details

Official title: A Phase II, International, Multicenter, Open Label Study of the Safety, Tolerability and Effectiveness of Three Intravenous Infusions of Antegren (Natalizumab) in Adolescents With Moderately to Severely Active Crohn's Disease

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Eligibility

Minimum age: 12 Years. Maximum age: 17 Years. Gender(s): 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.

Locations and Contacts

Royal Hospital for Sick Children, Edinburgh EH9 1LF, United Kingdom

Royal Free Medical School, London NWS 2QG, United Kingdom

Cedars-Sinai IBD Center, Los Angeles, California 90048, United States

Connecticut Children's Medical Center, Hartford, Connecticut 06106, United States

Miami Research Associates, Miami, Florida 33173, United States

Johns Hopkins University School of Medicine, Baltimore, Maryland 21287-2631, United States

Mass General Hospital for Children, Pediatric GI & Nutrition, Boston, Massachusetts 02114, United States

The Children's Hospital, Boston, Massachusetts 02115, United States

University of Rochester, Rochester, New York 14642, United States

Carolina Digestive Health Associates, Charlotte, North Carolina 28211, United States

Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104-4399, United States

Medical College of Wisconsin, Milwaukee, Wisconsin 53226, United States

Additional Information

Starting date: April 2002
Last updated: March 6, 2012

Page last updated: August 23, 2015

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