Multiple Sclerosis
Conditions
Keywords
multiple sclerosis, fingolimod, adult, FTY720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting MS, CFTY720D2406
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.
Interventions
DRUGFingolimod
Fingolimod 0.5 mg tablet
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Belgium, Germany, Italy
Participant flow
Pre-assignment details
Patients enrolled in study CFTY720D2406 who experienced a cardiovascular event within 24-hours of fingolimod treatment initiation/re-initiation which led to overnight monitoring or met serious adverse event criteria, were eligible to participate in this study CFTY720D2409.
Participants by arm
| Arm | Count |
|---|---|
| Fingolimod Fingolimod 0.5mg/day tablets taken orally. | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative problems | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Fingolimod |
|---|---|
| Age, Customized Ages 21 - 47 | 6 participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 6 |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 2 / 6 |
Outcome results
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.
Time frame: Within 6 months of qualifying event up to 64 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fingolimod | Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event | 0 participants |