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

Phase 4

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Fingolimod

• Registration Number: NCT02232061
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-04
• Study Start: 2014-09-29
• Primary Completion: 2020-01-24
• Study Completion: 2020-01-24
• Status Verified: 2021-01
• Results First Submitted: 2021-01-21
• Results First Submitted QC: 2021-01-21
• Last Update Submitted: 2021-01-21
• Results First Posted: 2021-02-10
• Last Update Posted: 2021-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fingolimod	Fingolimod	Fingolimod 0.5mg/day tablets taken orally.

Primary Outcome Measures

Name	Time	Method
Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event	Within 6 months of qualifying event up to 64 months	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.

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Napoli, Italy