NCT02225977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 31, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2017

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3.4 years

First QC Date

August 24, 2014

Last Update Submit

August 21, 2018

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Change in ratio of M2 versus M1 monocytes and macrophages.

    12 months

Study Arms (5)

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.

Interventions

GilenyaDRUG
Gilenya treated - 1 monthGilenya treated - 12 monthsGilenya treated - 3 monthsGilenya treated - 6 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California, Department of Neurology

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Study Officials

  • Brett T Lund, Ph.D.

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Neurology

Study Record Dates

First Submitted

August 24, 2014

First Posted

August 26, 2014

Study Start

July 31, 2013

Primary Completion

December 31, 2016

Study Completion

April 30, 2017

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations

US(1)