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Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.

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ClinicalTrials.gov Identifier: NCT02225977
Recruitment Status : Completed
First Posted : August 26, 2014
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Brett T. Lund, University of Southern California

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 circulation of patients with relapsing-remitting Multiple Sclerosis (MS). In this study we will determine the change in ratio of M2 (type II, alternatively activated) versus M1 (type I, classically activated) monocytes and macrophages in a cohort of patients that have received continuous Gilenya treatment for 0, 1, 3, 6 or 12 months. We will also assess changes in cell surface expression of the M1 marker CCR7 and the M2 markers CD206 or CD301 by monocytes and macrophages using FACS analysis of whole blood, and assess the tyrosine phosphorylation of the signal transducer and activator of transcription STAT-1 (pTyr-STAT1), which is critical for the activation of M1 myeloid cells. We will assess correlates with changes in M1 and M2 cytokine expression assessing possible mechanisms of action of Gilenya on myeloid lineage cells.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Gilenya

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Study Type : Observational
Actual Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.
Actual Study Start Date : July 31, 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : April 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Gilenya treated - 1 month
Patient's taking continuous oral Gilenya at prescribed dose for 1 month.
Drug: Gilenya
Gilenya treated - 3 months
Patient's taking continuous oral Gilenya at prescribed dose for 3 months.
Drug: Gilenya
Gilenya treated - 6 months
Patient's taking continuous oral Gilenya at prescribed dose for 6 months.
Drug: Gilenya
Gilenya treated - 12 months
Patient's taking continuous oral Gilenya at prescribed dose for 12 months.
Drug: Gilenya
Gilenya qualified - untreated
Patient's qualifying to start treatment with oral Gilenya at prescribed dose but still as yet untreated.



Primary Outcome Measures :
  1. Change in ratio of M2 versus M1 monocytes and macrophages. [ Time Frame: 12 months ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be selected from those seen by physicians at the USC Multiple Sclerosis Comprehensive Care Center.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225977


Locations
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United States, California
University of Southern California, Department of Neurology
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Brett T Lund, Ph.D. University of Southern California

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Responsible Party: Brett T. Lund, Assistant Professor of Neurology, University of Southern California
ClinicalTrials.gov Identifier: NCT02225977     History of Changes
Other Study ID Numbers: MSGilenya
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs