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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.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT00424788
First received: January 18, 2007
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  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:

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 May 23, 2013