Overview
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
Status:
Completed
Completed
Trial end date:
2019-06-28
2019-06-28
Target enrollment:
0
0
Participant gender:
All
All
Summary
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimodPhase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Novartis PharmaceuticalsTreatments:
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