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Open-Label Natalizumab Safety Extension Study

Sponsor
Biogen (Industry)
Overall Status
Completed
CT.gov ID
NCT00276172
Collaborator
(none)
1,615
Enrollment
1
Location
1
Arm
25
Duration (Months)
64.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
1615 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Dec 1, 2003
Actual Primary Completion Date :
Oct 1, 2005
Actual Study Completion Date :
Jan 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Natalizumab

Open-label natalizumab

Drug: Natalizumab
Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
Other Names:
  • Tysabri

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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. [Month 24]

    Secondary Outcome Measures

    1. EDSS scores and assessments of relapse. [Month 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in Cambridge Massachusetts United States 02142

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Michael Panzara, MD, MPH, Biogen
    • Principal Investigator: Paul O'Connor, MD, Unity Health Toronto
    • Study Chair: Eve Versage, Biogen Idec. Contact for more details

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00276172
    Other Study ID Numbers:
    • C-1808
    First Posted:
    Jan 13, 2006
    Last Update Posted:
    Jun 22, 2009
    Last Verified:
    Jun 1, 2009
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Natalizumab

    Study Results

    No Results Posted as of Jun 22, 2009