A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod

Completed · Phase 4

Conditions studied: Relapsing Multiple Sclerosis

In brief

A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod

Key facts

Study ID

NCT03257358

Run by

Novartis Pharmaceuticals

People needed

382

Starts

2017-09-19

Expected to finish

2019-06-28

Last updated by the study team

2021-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of relapsing forms of Multiple Sclerosis
• Patients who started commercially prescribed fingolimod therapy 0.5mg per day OR patients already on commercially prescribed fingolimod 0.5mg per day continuously for ≥ 2 years
• Exclusion Criteria (per USPI):
• Patients who in the last 6 months experienced myocardial infarction, unstable angina, stroke, transient ischemic stroke, decompensated heart failure requiring hospitalization or Class III/IV heart failure
• History or presence of Mobitz Type II second-degree or third-degree atrioventricular block or sick sinus syndrome, unless patient had a functioning pacemaker
• Baseline QTc interval ≥ 500 msec
• Treatment with Class Ia or Class III anti-arrhythmic drugs
• Patients who had a hypersensitivity reaction to fingolimod or any of the excipients

Where it is running

• Novartis Investigative Site — Cullman, Alabama, United States
• Novartis Investigative Site — Tucson, Arizona, United States
• Novartis Investigative Site — Berkeley, California, United States
• Novartis Investigative Site — Sacramento, California, United States
• Novartis Investigative Site — Colorado Springs, Colorado, United States
• Novartis Investigative Site — Louisville, Colorado, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Jacksonville, Florida, United States
• Novartis Investigative Site — Miami, Florida, United States
• Novartis Investigative Site — Ocala, Florida, United States
• Novartis Investigative Site — Port Charlotte, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Sunrise, Florida, United States
• Novartis Investigative Site — Vero Beach, Florida, United States
• Novartis Investigative Site — Savannah, Georgia, United States
• Novartis Investigative Site — Suwanee, Georgia, United States
• Novartis Investigative Site — Flossmoor, Illinois, United States
• Novartis Investigative Site — Kansas City, Kansas, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Lutherville, Maryland, United States
• Novartis Investigative Site — Foxborough, Massachusetts, United States
• Novartis Investigative Site — Lexington, Massachusetts, United States
• Novartis Investigative Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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