Open-Label Natalizumab Safety Extension Study | NCT00276172

Studies
Open-Label Natalizumab Safety Extension Study

NCT00276172

Sponsor

Biogen

Status

Completed

Last Update Posted

Jun 22, 2009Estimated

Enrollment

1,615Actual

Phase

Phase 3

Conditions

Multiple Sclerosis

Interventions

Natalizumab

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Oct 2005Actual

Completion Date

Jan 2006Actual

First Submitted Date

Jan 11, 2006

First Submission Date that Met QC Criteria

Jan 12, 2006

First Posted Date

Jan 13, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2009

Last Update Posted Date

Jun 22, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,615Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Natalizumab	Experimental	Open-label natalizumab	Drug: Natalizumab

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Natalizumab	Drug	Natalizumab 300 mg by IV infusion, every 4 weeks, for up to 24 months	Natalizumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
EDSS scores and assessments of relapse.		Month 24

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
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

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069442	Natalizumab

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided