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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)

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ClinicalTrials.gov Identifier: NCT00424788
Recruitment Status : Completed
First Posted : January 22, 2007
Last Update Posted : September 4, 2009
Sponsor:
Information provided by:
Biogen

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Relapsing Forms of Multiple Sclerosis Procedure: Plasma exchange Drug: natalizumab treatment Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : January 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Natalizumab
U.S. FDA Resources

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Study Director: Michael Panzara, MD MPH Biogen
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00424788     History of Changes
Other Study ID Numbers: 101MS001
First Posted: January 22, 2007    Key Record Dates
Last Update Posted: September 4, 2009
Last Verified: September 2009

Keywords provided by Biogen:
multiple sclerosis (MS)

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Natalizumab
Immunologic Factors
Physiological Effects of Drugs