E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
relapsing remitting multiple Sclerosis |
Sclerosi multipla recidivante-remittente |
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E.1.1.1 | Medical condition in easily understood language |
relapsing remitting multiple Sclerosis |
Sclerosi multipla recidivante-remittente |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10080700 |
E.1.2 | Term | Relapsing multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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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 use this multidimensional integrated approach to efficiently monitor multiple clinical parameters in MS patients during Ozanimod treatment in order to understand how neurodegeneration correlates with immunological parameters of neuroinflammation in RRMS patients over a 12-months observation period and to verify the therapeutical activity of Ozanimod on the inflammatory mediated neurodegeneration |
Utilizzare questo approccio integrato multidimensionale per monitorare in modo efficiente parametri clinici multipli nei pazienti con SM, durante il trattamento con Ozanimod, al fine di comprendere come la neurodegenerazione sia correlata ai parametri immunologici della neuroinfiammazione nei pazienti con SMRR in un periodo di osservazione di 12 mesi e per verificare l'attività terapeutica di Ozanimod sul neurodegenerazione infiammatoria. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1) Diagnosis of MS accordingly to 2017 revised McDonald criteria; 2) Patients candidate to receive Ozanimod therapy (disease characteristics, EDSS, age, lifestyle, disease progression, etc.); 3) Age between 18 and 45 years; 4) EDSS score from 0 to 4; 5) Signature and date of written ICF prior to entering the study; |
1) Diagnosi di SM secondo i criteri McDonald rivisti nel 2017 2) Pazienti candidati a ricevere la terapia con Ozanimod (caratteristiche della malattia, EDSS, età, stile di vita, progressione della malattia, ecc.); 3) Età compresa tra 18 e 45 anni; 4) Punteggio EDSS da 0 a 4; 5) Firma e data dell'ICF scritto prima dell'ingresso nello studio; |
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E.4 | Principal exclusion criteria |
1) Ongoing immunomodulatory or immunosuppressive treatment; 2) Other autoimmune comorbidities (i.e. antiphospolipid syndrome); 3) Treatment with steroids in the last 30 days before enrollment; 4) Acute inflammatory status not MS related (i.e. bacterial or viral infections) in the previous 30 days; 5) Patients unable to read and understand the documents of the study. 6) Participation in any interventional clinical trials or compassionate use programs 7) Contraindications and “not-recommendations” reported in SmPC |
1) Trattamento immunomodulatore o immunosoppressivo in corso; 2) Altre comorbidità autoimmuni (es. sindrome da antifospolipidi); 3) Trattamento con steroidi negli ultimi 30 giorni prima dell'arruolamento; 4) Stato infiammatorio acuto non correlato alla SM (cioè infezioni batteriche o virali) nei 30 giorni precedenti; 5) Pazienti incapaci di leggere e comprendere i documenti dello studio; 6) Partecipazione a qualsiasi sperimentazione clinica interventistica o programmi ad uso compassionevole; 7) Controindicazioni e “non raccomandazioni” riportate nell'RCP; |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the innate immune mediated inflammation in MS patients and to correlate it with the cognitive reserve and with serum NFL levels before and after Ozanimod treatment |
Valutare l'infiammazione innata immuno-mediata nei pazienti con SM e correlarla con la riserva cognitiva e con i livelli sierici di NFL prima e dopo il trattamento con Ozanimod |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
To observe the effect of Ozanimod on innate and adaptive immune cells in terms of activation, immune modulation and cell proliferation at the different time points. • To compare, through deep immune profiling, specific immune signatures between NEDA (no evident disease activity) and EDA (evident disease activity) patients; • To correlate specific immune profiles with clinical parameters such as lymphocyte counts, serum NFL, EEG connectivity patterns and/or MRI findings and to measure the effect of Ozanimod on these parameters; |
Osservare l'effetto di Ozanimod sulle cellule immunitarie innate e adattative in termini di attivazione, modulazione immunitaria e proliferazione cellulare nei diversi momenti; Per confrontare, attraverso un profilo immunitario profondo, firme immunitarie specifiche tra pazienti NEDA (nessuna attività di malattia evidente) ed EDA (attività di malattia evidente); Correlare specifici profili immunitari con parametri clinici quali conta linfocitaria, NFL sierica, pattern di connettività EEG e/o risultati della risonanza magnetica e misurare l'effetto di Ozanimod su questi parametri; |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
|
At the end of the 30th patient's treatment year |
Al completamento dell'anno di trattamento del trentesimo paziente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |