Status:
COMPLETED
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Lead Sponsor:
Biogen
Conditions:
Relapsing Forms of Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
EARLY_PHASE1
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 S...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2007
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00424788
Start Date
January 1 2007
End Date
October 1 2007
Last Update
September 4 2009
Active Locations (2)
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1
Cleveland Clinic Mellen Center for MS
Cleveland, Ohio, United States, 44195
2
Center for Neurological Disorders, Aurora Health Care
Milwaukee, Wisconsin, United States, 53201-0342