Back to resultsSafety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
natalizumab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility 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.
Sites / Locations
- Elan Pharmaceuticals
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00032799
First Posted
April 3, 2002
Last Updated
June 14, 2016
Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00032799
Brief Title
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
December 2001 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
September 2003 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
Collaborators
Elan Pharmaceuticals
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
905 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
natalizumab
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Elan Pharmaceuticals
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16267322
Citation
Sandborn WJ, Colombel JF, Enns R, Feagan BG, Hanauer SB, Lawrance IC, Panaccione R, Sanders M, Schreiber S, Targan S, van Deventer S, Goldblum R, Despain D, Hogge GS, Rutgeerts P; International Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) Trial Group; Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med. 2005 Nov 3;353(18):1912-25. doi: 10.1056/NEJMoa043335. Erratum In: N Engl J Med. 2015 May 21;372(21):2074.
Results Reference
result
Learn more about this trial
Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
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