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

August 21, 2018 updated by: Brett T. Lund, University of Southern California
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

125

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California, Department of Neurology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be selected from those seen by physicians at the USC Multiple Sclerosis Comprehensive Care Center.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in ratio of M2 versus M1 monocytes and macrophages.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 31, 2013

Primary Completion (Actual)

December 31, 2016

Study Completion (Actual)

April 30, 2017

Study Registration Dates

First Submitted

August 24, 2014

First Submitted That Met QC Criteria

August 24, 2014

First Posted (Estimate)

August 26, 2014

Study Record Updates

Last Update Posted (Actual)

August 22, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSGilenya

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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