Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks

Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks in Patients Treated With Fingolimod

This study will evaluate if patients who had a serious cardiovascular event upon initiation of fingolimod are at risk to delevop long term other cardiovascular events

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Fingolimod

Detailed Description

This was a multi-national, long-term safety study. Patients enrolled in study FTY720D2406 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation which led to overnight monitoring or met serious adverse event criteria, were eligible to participate in this study.

Patients who experienced a qualifying event in study CFTY720D2406 started study CFTY720D2409 approximately 6 months after the occurrence of the CFTY720D2406 qualifying event.

Patients underwent mandatory assessments on a 6-monthly basis including 12-lead ECG, vital signs. Other assessments were performed as per routine practice.

The primary objective of the study was to estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation.

The study has no stand-alone secondary objective. However data from the CFTY720D2409 and CFTY720D2406 studies will be pooled to supplement CFTY720DD2406 study and support its primary and secondary objectives of evaluating the safety profile of fingolimod.

The pooled data will be appended to this result upon completion of FDA submission.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Novartis Investigative Site
  • Hasselt, Belgium, 3500
    • Novartis Investigative Site
• Germany
  • Ravensburg, Germany, 88212
    • Novartis Investigative Site
• Italy
  • Napoli, Italy, 80131
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients participating in study FTY720D2406 who experienced a serious cardiovascular event during their fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria.
• Patients still on fingolimod after the this first dose serious event

Exclusion Criteria:

-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fingolimod; Fingolimod 0.5mg/day tablets taken orally.	Drug: Fingolimod; Fingolimod 0.5 mg tablet; Other Names: FTY720

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event	Participants from study CFTY720D2406 who experienced a qualifying cardiovascular adverse event were transferred to this study. Qualifying cardiovascular events included, but were not limited to, sudden unexplained death, cardiovascular death, myocardial infarction (MI), Q-wave MI, stroke (ischemic or hemorrhagic), unstable angina requiring hospitalization, congestive heart failure requiring hospitalization, complete heart block, ventricular fibrillation, torsade de pointes, hypertensive emergency and any other suspected life threatening cardiovascular condition.	Within 6 months of qualifying event up to 64 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2014
• Primary Completion (Actual): January 24, 2020
• Study Completion (Actual): January 24, 2020

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 2, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Actual): February 10, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: multiple sclerosis, fingolimod, adult, FTY720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting MS, CFTY720D2406
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Sphingosine 1 Phosphate Receptor Modulators; Fingolimod Hydrochloride
• Other Study ID Numbers: CFTY720D2409

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on

https://www.clinicalstudydatarequest.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No