Status:
COMPLETED
Modulation of Plasmacytoid Dendritic Cell Function in Multiple Sclerosis
Lead Sponsor:
Rutgers, The State University of New Jersey
Collaborating Sponsors:
Bayer
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Brief Summary
The purpose of this study is to determine whether interferon-beta impairs the ability of plasmacytoid dendritic cells to promote pathogenic immune responses in patients with multiple sclerosis.
Eligibility Criteria
Inclusion
- Males and females, 18 to 60 year old, inclusive.
- Diagnosis of a relapsing form of multiple sclerosis as determined by revised McDonald Criteria or at least one clinical demyelinating episode with abnormal brain MRI study based on CHAMPS criteria
- Expanded disability status scale (EDSS) score less than 6 at entry.
- Understand and sign written informed consent prior to any testing under this protocol, including screening tests and evaluations that are not considered part of the subject's routine care.
Exclusion
- Treatment with corticosteroids within one month prior to the study. Treatment with immunomodulatory drugs within last 3 months prior to the study.
- No history of treatment with Interferon-beta(IFN-beta) based drugs to exclude the possibility of IFN-beta neutralizing antibodies
- Any patient who is pregnant, intend to become pregnant, or breastfeeding at any time of the study.
- History of any significant cardiac, gastrointestinal, hepatic, pulmonary, or renal disease; immune deficiency; or other medical conditions that would preclude IFN-beta therapy.
- Primary Progressive Multiple Sclerosis patients or patients with Secondary Progressive Multiple Sclerosis with lack of recent clinical relapses for more than 2 years
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00468182
Start Date
April 1 2007
End Date
December 1 2011
Last Update
May 7 2015
Active Locations (1)
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1
Rutgers-RWJMS
New Brunswick, New Jersey, United States, 08901