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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232061
• Other study ID #: CFTY720D2409
• Status: Completed
• Phase: Phase 4
• Start date: September 29, 2014
• Est. completion date: January 24, 2020

Study information

• Verified date: January 2021
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: January 24, 2020
• Est. primary completion date: January 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Fingolimod
Fingolimod 0.5 mg tablet

Locations

Country	Name	City	State
Belgium	Novartis Investigative Site	Gent
Belgium	Novartis Investigative Site	Hasselt
Germany	Novartis Investigative Site	Ravensburg
Italy	Novartis Investigative Site	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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