Study:
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Rationale:
n/a
Purpose:
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.
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Relapsing Forms of Multiple Sclerosis |
Procedure: Plasma exchange
Drug: natalizumab treatment |
Phase 0 |
Verified by
Biogen Idec
September, 2009
Sponsored by: Biogen Idec
Information provided by: Biogen Idec
ClinicalTrials.gov identifier: NCT00424788
Study Type: Interventional
Study Design: Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic Mellen Center for MS
Cleveland, Ohio 44195
United States
Michael Panzara, MD MPH., Study Director