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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00055367

Enrollment

Registered

2003-02-28

Start date

2002-04-30

Completion date

2004-05-31

Last updated

2016-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Disease

Brief 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.

Interventions

DRUGnatalizumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 17 Years

Healthy volunteers

Inclusion 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.

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026