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OpenTrials
Completed

NCT Number: NCT00276172

Open-Label Natalizumab Safety Extension Study

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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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in

Cambridge, Massachusetts, 02142, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natalizumab

Drug

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

Other names: Tysabri

Primary outcomes

  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.

    Time frame: Month 24

Secondary outcomes

  1. EDSS scores and assessments of relapse.

    Time frame: Month 24

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Jan 13, 2006
Registry last updated
Jun 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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