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Open-Label Natalizumab Safety Extension Study

NCT00276172 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1615

Last updated 2009-06-22

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Natalizumab

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

Sponsors & Collaborators

Principal Investigators

  • Michael Panzara, MD, MPH · Biogen

  • Paul O'Connor, MD · Unity Health Toronto

  • Eve Versage · Biogen Idec. Contact for more details

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2005-10-31
Completion
2006-01-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00276172 on ClinicalTrials.gov