NCT00276172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,615

participants targeted

Target at P75+ for phase_3 multiple-sclerosis

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2006

Completed
Last Updated

June 22, 2009

Status Verified

June 1, 2009

Enrollment Period

1.8 years

First QC Date

January 11, 2006

Last Update Submit

June 19, 2009

Conditions

Multiple Sclerosis

Outcome Measures

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.

    Month 24

Secondary Outcomes (1)

  • EDSS scores and assessments of relapse.

    Month 24

Study Arms (1)

Natalizumab

EXPERIMENTAL

Open-label natalizumab

Drug: Natalizumab

Interventions

NatalizumabDRUG

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

Also known as: Tysabri
Natalizumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must give written informed consent.
  • Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Michael Panzara, MD, MPH

    Biogen

    STUDY DIRECTOR

  • Paul O'Connor, MD

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

  • Eve Versage

    Biogen Idec. Contact for more details

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 11, 2006

First Posted

January 13, 2006

Study Start

December 1, 2003

Primary Completion

October 1, 2005

Study Completion

January 1, 2006

Last Updated

June 22, 2009

Record last verified: 2009-06

Locations

US(1)