ong-term, multicenter study assessing long-term heart risks in patients treated with fingolimod

Phase 1

• Conditions: Cardiovascular risk; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-001241-24-BE
• Lead Sponsor: ovartis Pharma Service AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-07
• Last Update Posted: 30 March 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Patients eligible for inclusion in this study have to fulfill all of the following criteria:
1. Written informed consent must be obtained before any assessment is performed
2. Patient experienced a cardiovascular event within 24-hours of fingolimod treatment initiation or re-initiation which led to overnight monitoring or met seriousness criteria
3. Patient experienced this cardiovascular event while participating in the study CFTY720D2406
4. Patient continues receiving fingolimod after the first dose event
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation, as defined by the incidence of selected cardiovascular events over the course of the study.;Secondary Objective: The study has no stand-alone secondary objective. However, data from the D2409 and D2406 studies will be pooled to supplement D2406 study and support its<br>primary and secondary objectives.;Primary end point(s): To estimate the long-term cardiovascular risk of fingolimod in patients who experienced a cardiovascular event during treatment initiation, as defined by the incidence of selected cardiovascular events over the course of the study.;Timepoint(s) of evaluation of this end point: Patients will be assessed at study entry visit, every 6 months for routine study visit, fingolimod discontinuation, 6-months follow-up, and end of study.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The study has no stand-alone secondary objective. However it will supplement D2406 study and support its primary and secondary objectives.;Timepoint(s) of evaluation of this end point: Patients will be assessed at study entry visit, every 6 months for routine study visit, fingolimod discontinuation, 6-months follow-up, and end of study.