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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: Completed study, sponsored by University of Southern California.
NCT02225977 is a clinical trial that has completed, run by University of Southern California. The registered enrollment target is 125 participants. According to ClinicalTrials.gov, the official US trial registry.
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
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2013-07-31 |
| Est. Completion | 2017-04-30 |
What the finished NCT02225977 record still lists
NCT02225977 is an observational study that tracks outcomes without assigning an intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Gilenya is the first listed.
NCT02225977 does not publish any study locations in the registry export this page uses.
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.
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