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

• Status: Completed
• Trial end date: 2019-06-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

Criteria

Inclusion Criteria:

• 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