Status:
COMPLETED
A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS) after treatment with 0.5mg fingolimod
Detailed Description
This study used a 2-cohort, nonrandomized, open-label, multicenter design. Cohort 1: The first cohort was to be comprised of approximately 200 patients with RMS, who were newly prescribed commercially...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 28 2019
Estimated Enrollment :
382 Patients enrolled
Trial Details
Trial ID
NCT03257358
Start Date
September 19 2017
End Date
June 28 2019
Last Update
October 7 2021
Active Locations (66)
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1
Novartis Investigative Site
Birmingham, Alabama, United States, 35209
2
Novartis Investigative Site
Cullman, Alabama, United States, 35058
3
Novartis Investigative Site
Tucson, Arizona, United States, 85718
4
Novartis Investigative Site
Berkeley, California, United States, 94705