Back to resultsOpen-Label Natalizumab Safety Extension Study
Primary Purpose
Multiple Sclerosis
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 Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria: Must give written informed consent. Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803 Exclusion Criteria: History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment. History of severe allergic or anaphylactic reactions or known drug hypersensitivity A clinically significant infectious illness within 30 days prior to study entry.
Sites / Locations
- Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Natalizumab
Arm Description
Open-label natalizumab
Outcomes
Primary Outcome Measures
The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.
Secondary Outcome Measures
EDSS scores and assessments of relapse.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00276172
Brief Title
Open-Label Natalizumab Safety Extension Study
Official Title
An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
October 2005 (Actual)
Study Completion Date
January 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1615 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Natalizumab
Arm Type
Experimental
Arm Description
Open-label natalizumab
Intervention Type
Drug
Intervention Name(s)
Natalizumab
Other Intervention Name(s)
Tysabri
Intervention Description
Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
Primary Outcome Measure Information:
Title
The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.
Time Frame
Month 24
Secondary Outcome Measure Information:
Title
EDSS scores and assessments of relapse.
Time Frame
Month 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Must give written informed consent.
Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803
Exclusion Criteria:
History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment.
History of severe allergic or anaphylactic reactions or known drug hypersensitivity
A clinically significant infectious illness within 30 days prior to study entry.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Panzara, MD, MPH
Organizational Affiliation
Biogen
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Paul O'Connor, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eve Versage
Organizational Affiliation
Biogen Idec. Contact for more details
Official's Role
Study Chair
Facility Information:
Facility Name
Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in
City
Cambridge
State/Province
Massachusetts
ZIP/Postal Code
02142
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open-Label Natalizumab Safety Extension Study
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