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

Novartis

Status and phase: Completed; Phase 4

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: Fingolimod

Study type: Interventional

Funder types: Industry

Identifiers

NCT03257358

CFTY720DUS40

Details and patient eligibility

About

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

Full 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 available fingolimod 0.5 mg/day. Cohort 2: The second cohort was to be comprised of approximately 200 RMS patients who had been on commercially available fingolimod 0.5 mg/day continuously without interruption of treatment for at least ≥ 2 years. Patients from both cohorts were recruited simultaneously from up to 125 MS centers in the United States. Both cohorts ran concurrently. The study consisted of 2 periods: Screening (up to 4 weeks) and Treatment period from Baseline (end of screening period considered as Day 1) up to 12 months with visits conducted at 3,6 and 12 months with a 14 day follow-up post treatment..

Enrollment: 382 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

382 participants in 2 patient groups

Cohort 1

Other group

Description:

RMS patients who were newly prescribed commercially available fingolimod 0.5mg per day

Treatment:

Drug: Fingolimod

Cohort 2

Other group

Description:

RMS patients who had been on commercially available fingolimod 0.5mg per day continuously for ≥ 2 years

Treatment:

Drug: Fingolimod