Status:
COMPLETED
Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.
Lead Sponsor:
University of Southern California
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Brief Summary
In this study we wish to test the hypothesis that continuous Gilenya treatment alters immune homeostasis in favor of an anti-inflammatory type II monocyte and macrophage (M2) phenotype in the circulat...
Eligibility Criteria
Inclusion
- Patients must qualify to receive treatment with Gilenya, according to the University of Southern California, Department of Neurology, MS Group, Gilenya Prescribing Process.
- Clinically definite Multiple Sclerosis defined by the revised McDonald criteria (Polman et al., 2005, Polman et al., 2010) of the relapsing-remitting form with an Expanded Disability Status Scale (EDSS) score of 0 to 5.5.
- Ability to understand and sign this study-specific institutional review board-approved informed consent form.
- Willing to donate \~50mls of blood for immunological testing on up to five occasions.
Exclusion
- Patient does not qualify to receive treatment with Gilenya, according to the USC, Department of Neurology, MS Group, Gilenya Prescribing Process.
- Inability to understand nature of the study.
- Treatment with any of the following within 30 days of commencing treatment with Gilenya: Avonex, Betaseron, Rebif, Copaxone, Natalizumab, Rituximab, Mitoxantrone, Cyclophosphamide, Cyclosporine, Azathioprine, Methotrexate or any other immunomodulatory, immunosuppressant or immune homeostasis altering drug.
Key Trial Info
Start Date :
July 31 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT02225977
Start Date
July 31 2013
End Date
April 30 2017
Last Update
August 22 2018
Active Locations (1)
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1
University of Southern California, Department of Neurology
Los Angeles, California, United States, 90033