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OpenTrials
Completed

NCT Number: NCT00424788

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.

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Key information

Conditions

Relapsing Forms of Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Cleveland Clinic Mellen Center for MS, Cleveland, Ohio, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plasma Exchange

Procedure

natalizumab treatment

Drug

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Jan 22, 2007
Registry last updated
Sep 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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