Open-Label Natalizumab Safety Extension Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1615 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-12-31

Study Completion Date

2006-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Natalizumab

Open-label natalizumab

Group Type EXPERIMENTAL

Natalizumab

Intervention Type DRUG

Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months

Interventions

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Natalizumab

Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months

Intervention Type DRUG

Other Intervention Names

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Tysabri

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No