Status:
COMPLETED
A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple Sclerosis
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
Study Title: A Serologic Study to Correlate b-IFN NAb titers to b-IFN Induced Biomarker Response in Patients with Multiple Sclerosis Objectives: Subjects currently on any of the three b-IFN preparati...
Eligibility Criteria
Inclusion
- Patients (male or female) diagnosed with relapsing forms of MS.
- Currently being treated with the same b-IFN (in accordance with FDA approved dosing and schedules) for 12 to 48 months inclusive.
- All levels of disability
- Age 18-65 years inclusive
- Subjects must be willing to be followed for the 6-month study period.
Exclusion
- Patients with prior b-IFN NAb test (whether positive or negative).
- Patients who are currently being treated or have been treated within 6 months prior to screening with combination therapy (b-IFN plus any other immunosuppressant/immunomodulatory) other than IV steroids (either pulse or for a relapse).
- Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the study protocol.
- Any other reasons that, in the opinion of the Investigator, the subject is determined to be unsuitable for enrollment into this study.
Key Trial Info
Start Date :
January 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2007
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00288990
Start Date
January 1 2006
End Date
August 1 2007
Last Update
December 24 2007
Active Locations (28)
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1
University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
2
Physicians Resource Network
Cullman, Alabama, United States, 35058
3
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
4
University of California - Irvine
Irvine, California, United States, 92697