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

NCT ID: NCT00424788

Last Updated: 2009-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-10-31

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.

Conditions

Relapsing Forms of Multiple Sclerosis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Plasma exchange

Intervention Type: PROCEDURE

natalizumab treatment

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biogen

INDUSTRY

Sponsor Role: lead

Principal Investigators

Michael Panzara, MD MPH

Role: STUDY_DIRECTOR

Biogen

Locations

Cleveland Clinic Mellen Center for MS

Cleveland, Ohio, United States

Center for Neurological Disorders, Aurora Health Care

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

101MS001

Identifier Type: -

Identifier Source: org_study_id