Open-Label Natalizumab Safety Extension Study

Biogen

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: Natalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT00276172

C-1808

Details and patient eligibility

About

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.

Enrollment: 1,615 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,615 participants in 1 patient group

Natalizumab

Experimental group

Description:

Open-label natalizumab

Treatment:

Drug: Natalizumab