Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease

A Phase 3 International, Multicenter, Double-blind, Placebo-controlled Study of the Safety, Efficacy, and Tolerability of Intravenous Antegren (Natalizumab) in Subjects With Moderate to Severely Active Crohn's Disease

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00032799

Enrollment

905

Registered

2002-04-04

Start date

2001-12-31

Completion date

2003-09-30

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 efficacy of natalizumab in individuals diagnosed with moderately to severely active Crohn's disease. 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.

Interventions

DRUGnatalizumab

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Male and female patients at least 18 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. Women must not be breastfeeding or pregnant, and must not become pregnant during the study.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 12, 2026