Safety and Efficacy of Natalizumab in the Treatment of 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 3
Status: Completed
Sponsored by: Elan Pharmaceuticals
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Elan Pharmaceuticals, San Diego, California 92121, United States
Additional Information
Starting date: December 2001
Last updated: March 6, 2012
|