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NCT02225977 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by University of Southern California.

Completed
Registry status
125
Enrollment target

NCT02225977 is a clinical trial that has completed, run by University of Southern California. The registered enrollment target is 125 participants.

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The verdict

NCT02225977 has completed, sponsored by University of Southern California.

COMPLETED
Registry status
125 participants
Enrollment target

Study 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.

Interventions

  • DRUG Gilenya

Trial Details

FieldValue
Enrollment Target 125 participants
Start Date 2013-07-31
Est. Completion 2017-04-30

Sponsor

University of Southern California

617 total trials

What the Registry Record Tells You About NCT02225977

The ClinicalTrials.gov registry entry for NCT02225977 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Gilenya is the first listed.

NCT02225977 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02225977 about?

NCT02225977 is a clinical study titled "Assessing Induction of Type II (M2) Monocytes/Macrophages in Patients Receiving Gilenya.". 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 th...

What is the current status of trial NCT02225977?

This trial is currently completed. The enrollment target is 125 participants. The study started on 2013-07-31. Estimated completion is 2017-04-30.

What interventions are being tested in trial NCT02225977?

The interventions under investigation include: Gilenya (DRUG).

Who is sponsoring clinical trial NCT02225977?

This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.