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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingolimod | Experimental | Fingolimod 0.5mg/day tablets taken orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fingolimod | Drug | Fingolimod 0.5 mg tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
-Treatment with any investigational drug unless it is received as part of a Novartis sponsored MS study lasting less than 1 month
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Ghent | 9000 | Belgium | |||
| Novartis Investigative Site |
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
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fingolimod | Fingolimod 0.5mg/day tablets taken orally. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fingolimod | Fingolimod 0.5mg/day tablets taken orally. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | Within 6 months of qualifying event up to 64 months |
|
Within 6 months of qualifying event up to approximately 64 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fingolimod | Fingolimod 0.5mg/day tablets taken orally | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (22.1) | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | +1 862 778 8300 | Novartis.email@Novartis.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2019 | Jan 21, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 21, 2020 | Jan 21, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D003711 | Demyelinating Diseases |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D001327 | Autoimmune Diseases |
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| ID | Term |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Hasselt |
| 3500 |
| Belgium |
| Novartis Investigative Site | Ravensburg | 88212 | Germany |
| Novartis Investigative Site | Naples | 80131 | Italy |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 6 |
| 2 |
| 6 |
| 4 |
| 6 |
| BRONCHITIS VIRAL | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (22.1) | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| HYPOTHYROIDISM | Endocrine disorders | MedDRA (22.1) | Systematic Assessment |
|
| HAEMORRHOIDAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (22.1) | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| TRICHOMONIASIS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| VIRAL PHARYNGITIS | Infections and infestations | MedDRA (22.1) | Systematic Assessment |
|
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA (22.1) | Systematic Assessment |
|
| FOLATE DEFICIENCY | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
|
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
|
| HYPERPHAGIA | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
|
| VITAMIN D DEFICIENCY | Metabolism and nutrition disorders | MedDRA (22.1) | Systematic Assessment |
|
| BURSITIS | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| FACET JOINT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA (22.1) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA (22.1) | Systematic Assessment |
|
| PREGNANCY | Pregnancy, puerperium and perinatal conditions | MedDRA (22.1) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (22.1) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (22.1) | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA (22.1) | Systematic Assessment |
|
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.
| D007154 | Immune System Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |