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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02225977 |
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Date of registration:
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24/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.
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Scientific title:
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Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya. |
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Date of first enrolment:
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July 31, 2013 |
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Target sample size:
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125 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02225977 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Brett T Lund, Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Southern California |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: Gilenya
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Primary Outcome(s)
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Change in ratio of M2 versus M1 monocytes and macrophages.
[Time Frame: 12 months]
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Secondary ID(s)
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MSGilenya
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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