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

Biogen

Status and phase

Completed

Early Phase 1

Conditions

Relapsing Forms of Multiple Sclerosis

Treatments

Procedure: Plasma exchange

Drug: natalizumab treatment

Study type

Interventional

Funder types

Industry

Identifiers

NCT00424788

101MS001

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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