E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
primary and secondary objectives. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | 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. |
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E.5.2 | 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. |
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E.5.2.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 40 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Germany |
Italy |
Netherlands |
Thailand |
United Kingdom |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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D2409 enrollment period will be open until 1-year before the end of D2406 study and the study will last until the end of the D2406 study i.e. five years after the last patient has been enrolled in the D2406 study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 5 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 10 |