Open-Label Natalizumab Safety Extension Study

Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00276172
• Other study ID #: C-1808
• Status: Completed
• Phase: Phase 3
• First received: January 11, 2006
• Last updated: June 19, 2009
• Start date: December 2003
• Est. completion date: January 2006

Study information

• Verified date: June 2009
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaAustria: Federal Ministry of Social Security, Generations, and Consumer ProtectionBelgium: Directorate General for Medicinal ProductsCzech Republic: State Institute for Drug ControlDenmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyFrance: French Health Products Safety AgencyGermany: Federal Institute for Drugs and Medical DevicesGreece: National Organisation for MedicinesHungary: National Institute of PharmacyIreland: Irish Medicines BoardItaly: Ministry of HealthNetherlands: Dutch Healthcare Inspectorate, Medicines Evaluation BoardNew Zealand: National Institute of PharmacyPoland: Office for Medicinal ProductsSpain: Spanish Medicines AgencySweden: Medicinal Products AgencySwiterland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1615
• Est. completion date: January 2006
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	Performed at only C-1801, C-1802, and C-1803 sites globally. No general public enrollment. Biogen Idec is located in	Cambridge	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	EDSS scores and assessments of relapse.		Month 24	No