A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod
Status: | Recruiting |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 8/16/2018 |
Start Date: | September 19, 2017 |
End Date: | July 1, 2019 |
Contact: | Novartis Pharmaceuticals |
Email: | novartis.email@novartis.com |
Phone: | 1-888-669-6682 |
A 12-Month, Prospective, Multicenter, Two-cohort, Nonrandomized, Open-label Study in Adult Patients With Relapsing Multiple Sclerosis (RMS), to Investigate Changes in Immune Phenotype Biomarkers After Treatment With 0.5mg Fingolimod [FLUENT]
A study of immune phenotype biomarkers in patients with Relapsing Multiple Sclerosis (RMS)
after treatment with 0.5mg fingolimod
after treatment with 0.5mg fingolimod
Inclusion Criteria:
- Diagnosis of relapsing forms of Multiple Sclerosis
- Patients who will start 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 has a functioning pacemaker
- Baseline QTc interval ≥ 500 msec
- Treatment with Class Ia or Class III anti-arrhythmic drugs
- Patients who have had a hypersensitivity reaction to fingolimod or any of the
excipients
Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
71
sites
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Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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