Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00032799
Collaborator
Elan Pharmaceuticals (Industry)
905
1
21
43.1
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
905 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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 Start Date
:
Dec 1, 2001
Actual Primary Completion Date
:
Sep 1, 2003
Actual Study Completion Date
:
Sep 1, 2003
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Elan Pharmaceuticals | San Diego | California | United States | 92121 |
Sponsors and Collaborators
- Biogen
- Elan Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Biogen
ClinicalTrials.gov Identifier:
NCT00032799
Other Study ID Numbers:
- CD301
First Posted:
Apr 4, 2002
Last Update Posted:
Jun 16, 2016
Last Verified:
Mar 1, 2012