Back to resultsA Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Primary Purpose
Relapsing Forms of Multiple Sclerosis
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Plasma exchange
natalizumab treatment
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing Forms of Multiple Sclerosis focused on measuring multiple sclerosis (MS)
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
Sites / Locations
- Cleveland Clinic Mellen Center for MS
- Center for Neurological Disorders, Aurora Health Care
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00424788
Brief Title
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Official Title
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Biogen
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Forms of Multiple Sclerosis
Keywords
multiple sclerosis (MS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Plasma exchange
Intervention Type
Drug
Intervention Name(s)
natalizumab treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Panzara, MD MPH
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Cleveland Clinic Mellen Center for MS
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Center for Neurological Disorders, Aurora Health Care
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53201-0342
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Multicenter Study to Assess the Effect of Plasma Exchange in Accelerating the Clearance of Natalizumab in Subjects With Multiple Sclerosis (MS)
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