Trial Outcomes & Findings for Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks (NCT NCT02232061)

NCT ID: NCT02232061

Last Updated: 2021-02-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

6 participants

Primary outcome timeframe

Within 6 months of qualifying event up to 64 months

Results posted on

2021-02-10

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Fingolimod Fingolimod 0.5mg/day tablets taken orally.
Overall Study STARTED	6
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Fingolimod Fingolimod 0.5mg/day tablets taken orally.
Overall Study Administrative problems	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fingolimod n=6 Participants Fingolimod 0.5mg/day tablets taken orally.
Age, Customized Ages 21 - 47	6 participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Within 6 months of qualifying event up to 64 months

Outcome measures

Outcome measures
Measure	Fingolimod n=6 Participants Fingolimod 0.5mg/day tablets taken orally.
Participants Who Experienced at Least One Qualifying Cardiovascular Adverse Event	0 participants

Adverse Events

Fingolimod

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fingolimod n=6 participants at risk Fingolimod 0.5mg/day tablets taken orally
Blood and lymphatic system disorders LYMPHOPENIA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Infections and infestations BRONCHITIS VIRAL	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Respiratory, thoracic and mediastinal disorders ASTHMA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months

Other adverse events

Other adverse events
Measure	Fingolimod n=6 participants at risk Fingolimod 0.5mg/day tablets taken orally
General disorders PYREXIA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Blood and lymphatic system disorders LYMPHOPENIA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Endocrine disorders HYPOTHYROIDISM	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Gastrointestinal disorders HAEMORRHOIDAL HAEMORRHAGE	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Infections and infestations NASOPHARYNGITIS	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Infections and infestations TRICHOMONIASIS	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Infections and infestations VIRAL PHARYNGITIS	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Injury, poisoning and procedural complications INFUSION RELATED REACTION	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Metabolism and nutrition disorders FOLATE DEFICIENCY	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Metabolism and nutrition disorders HYPERCHOLESTEROLAEMIA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Metabolism and nutrition disorders HYPERPHAGIA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Metabolism and nutrition disorders VITAMIN D DEFICIENCY	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Musculoskeletal and connective tissue disorders BURSITIS	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Musculoskeletal and connective tissue disorders FACET JOINT SYNDROME	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Musculoskeletal and connective tissue disorders TENDONITIS	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Nervous system disorders HEADACHE	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Nervous system disorders MULTIPLE SCLEROSIS RELAPSE	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Nervous system disorders SCIATICA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Pregnancy, puerperium and perinatal conditions PREGNANCY	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Psychiatric disorders ANXIETY	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Psychiatric disorders INSOMNIA	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months
Vascular disorders HOT FLUSH	16.7% 1/6 • Within 6 months of qualifying event up to approximately 64 months

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: +1 862 778 8300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER