NCT02232061

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_4 multiple-sclerosis

Timeline
Completed

Started Sep 2014

Longer than P75 for phase_4 multiple-sclerosis

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 4, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

September 29, 2014

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2020

Completed
1 year until next milestone

Results Posted

Study results publicly available

February 10, 2021

Completed
Last Updated

February 10, 2021

Status Verified

January 1, 2021

Enrollment Period

5.3 years

First QC Date

September 2, 2014

Results QC Date

January 21, 2021

Last Update Submit

January 21, 2021

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, fingolimod, adult, FTY720, inflammatory disease, demyelination, auto-inflammatory disease, relapsing-remitting MS, CFTY720D2406

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Fingolimod

EXPERIMENTAL

Fingolimod 0.5mg/day tablets taken orally.

Drug: Fingolimod

Interventions

FingolimodDRUG

Fingolimod 0.5 mg tablet

Also known as: FTY720
Fingolimod

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Hasselt, 3500, Belgium

Location

Novartis Investigative Site

Ravensburg, 88212, Germany

Location

Novartis Investigative Site

Napoli, 80131, Italy

Location

MeSH Terms

Conditions

Multiple SclerosisDemyelinating Diseases

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

SphingosineAmino AlcoholsAlcoholsOrganic ChemicalsPropylene GlycolsGlycolsAmines

Limitations and Caveats

This study had no stand-alone secondary objectives. However, data from the CFTY720D2409 and D2406 studies will be pooled to supplement this study and will be appended to this record when available.

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@Novartis.com
+1 862 778 8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2014

First Posted

September 4, 2014

Study Start

September 29, 2014

Primary Completion

January 24, 2020

Study Completion

January 24, 2020

Last Updated

February 10, 2021

Results First Posted

February 10, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

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/

Locations

BE(2)DE(1)IT(1)