Open-Label Natalizumab Safety Extension Study

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00276172
First received: January 11, 2006
Last updated: June 19, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Multiple Sclerosis
Drug: Natalizumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • EDSS scores and assessments of relapse. [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Enrollment: 1615
Study Start Date: December 2003
Study Completion Date: January 2006
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Natalizumab
Open-label natalizumab
Drug: Natalizumab
Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months
Other Name: Tysabri

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276172

Locations
United States, Massachusetts
Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in
Cambridge, Massachusetts, United States, 02142
Sponsors and Collaborators
Biogen Idec
Investigators
Study Director: Michael Panzara, MD, MPH Biogen Idec
Principal Investigator: Paul O'Connor, MD St. Michael's Hospital, Toronto
Study Chair: Eve Versage Biogen Idec. Contact for more details
  More Information

No publications provided

Responsible Party: Biogen Idec MD, Biogen Idec
ClinicalTrials.gov Identifier: NCT00276172     History of Changes
Other Study ID Numbers: C-1808
Study First Received: January 11, 2006
Last Updated: June 19, 2009
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Austria: Federal Ministry of Social Security, Generations, and Consumer Protection
Belgium: Directorate General for Medicinal Products
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: French Health Products Safety Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organisation for Medicines
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Italy: Ministry of Health
Netherlands: Dutch Healthcare Inspectorate, Medicines Evaluation Board
New Zealand: National Institute of Pharmacy
Poland: Office for Medicinal Products
Spain: Spanish Medicines Agency
Sweden: Medicinal Products Agency
Switerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014