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

June 14, 2016 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

Elan Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

May 1, 2004

Study Completion (Actual)

May 1, 2004

Study Registration Dates

First Submitted

February 26, 2003

First Submitted That Met QC Criteria

February 27, 2003

First Posted (Estimate)

February 28, 2003

Study Record Updates

Last Update Posted (Estimate)

June 16, 2016

Last Update Submitted That Met QC Criteria

June 14, 2016

Last Verified

March 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD305

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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