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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
ClinicalTrials.gov Identifier:
NCT00424788
First received: January 18, 2007
Last updated: September 3, 2009
Last verified: September 2009
History of Changes

January 18, 2007
September 3, 2009
January 2007
October 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00424788 on ClinicalTrials.gov Archive Site
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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)
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
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.
Not Provided
Interventional
Phase 0
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing Forms of Multiple Sclerosis
  • Procedure: Plasma exchange
  • Drug: natalizumab treatment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
October 2007
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00424788
101MS001
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Biogen
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Study Director: Michael Panzara, MD MPH Biogen
Biogen
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP