MedTrace Logo

Natalizumab Re-Initiation of Dosing

NCT00306592 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 404

Last updated 2017-03-21

Study results available
· View outcomes & findings →

Summary

The primary objectives of this study are to further evaluate the safety of natalizumab (Tysabri®) monotherapy by evaluating the risk of hypersensitivity and immunogenicity following re-exposure to natalizumab, and to confirm the safety of switching to natalizumab from interferon beta (IFN-β), glatiramer acetate (GA), or other multiple sclerosis (MS) therapies.

Conditions

  • Multiple Sclerosis, Relapsing-Remitting

Interventions

BIOLOGICAL

BG00002 (natalizumab)

Sponsors & Collaborators

  • Elan Pharmaceuticals

    collaborator INDUSTRY

  • Biogen

    lead INDUSTRY

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2007-12-31
Completion
2008-02-29

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

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 NCT00306592 on ClinicalTrials.gov