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

NCT00424788 | Completed Early Phase 1

• 1 other identifier: 101MS001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

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

Keywords

multiple sclerosis (MS)

Interventions

Plasma exchange PROCEDURE

natalizumab treatment DRUG

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (2)

Cleveland Clinic Mellen Center for MS

Cleveland, Ohio, 44195, United States

Location

Center for Neurological Disorders, Aurora Health Care

Milwaukee, Wisconsin, 53201-0342, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Plasma Exchange

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Blood Transfusion; Biological Therapy; Therapeutics; Plasmapheresis; Blood Component Removal; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Michael Panzara, MD MPH

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2007
• First Posted: January 22, 2007
• Study Start: January 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: September 4, 2009

Record last verified: 2009-09

Locations

US (2)