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

Biogen1 site in 1 country1,615 target enrollmentDecember 2003

ConditionsMultiple Sclerosis

InterventionsNatalizumab

DrugsNatalizumab

Overview

Phase: Phase 3
Intervention: Natalizumab
Conditions: Multiple Sclerosis
Sponsor: Biogen
Enrollment: 1615
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2003

End Date

January 2006

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Biogen

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.

Arms & Interventions

Natalizumab

Open-label natalizumab

Intervention: Natalizumab

Outcomes

Primary Outcomes

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