A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)

This study has been completed.

First Received on January 18, 2007. Last Updated on September 3, 2009 History of Changes

Sponsor:	Biogen Idec
Information provided by:	Biogen Idec
ClinicalTrials.gov Identifier:	NCT00424788

Purpose

Natalizumab (TYSABRI) is a protein-based drug that is manufactured by Biogen Idec in partnership with Elan Pharmaceuticals. Natalizumab is approved in the US and Europe for the treatment of Multiple Sclerosis (MS). The purpose of this study is to determine whether the amount of natalizumab (TYSABRI) that is present in your blood (plasma) can be reduced or eliminated by separating and removing the plasma and replacing it with other fluids, a process called plasma exchange.

Condition	Intervention	Phase
Relapsing Forms of Multiple Sclerosis	Procedure: Plasma exchange Drug: natalizumab treatment	Phase 0

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Natalizumab

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Estimated Enrollment:	12
Study Start Date:	January 2007
Study Completion Date:	October 2007
Primary Completion Date:	October 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

considered by the Investigator to be free of signs and symptoms suggestive of any serious opportunistic infection
willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including interferon beta and glatiramer acetate) for the duration of the study
willing and able to comply with the site's plasma exchange protocol which may require hospitalization or daily visits

Exclusion Criteria:

considered by the Investigator to be immunocompromised
history of, or available abnormal laboratory results indicative of any major disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent for the duration of the study.
condition(s) considered to be contraindication(s) for plasma exchange, including but not limited to bleeding diathesis, hypotension, or vascular access limitations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00424788

Locations

United States, Ohio
Cleveland Clinic Mellen Center for MS
Cleveland, Ohio, United States, 44195
United States, Wisconsin
Center for Neurological Disorders, Aurora Health Care
Milwaukee, Wisconsin, United States, 53201-0342

Sponsors and Collaborators

Biogen Idec

Investigators

Study Director:

Michael Panzara, MD MPH

Biogen Idec

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00424788 History of Changes
Other Study ID Numbers:	101MS001
Study First Received:	January 18, 2007
Last Updated:	September 3, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Biogen Idec:

multiple sclerosis (MS)

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 February 09, 2012