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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 moderate 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 Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With 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 moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).

Locations and Contacts

Additional Information

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

Page last updated: August 23, 2015

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