E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Subjects with relapsing-remitting multiple sclerosis |
Pazienti affetti da Sclerosi Multipla recidivante-remittente |
|
E.1.1.1 | Medical condition in easily understood language |
Multiple Sclerosis |
Sclerosi Multipla |
|
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 | 19.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10063399 |
E.1.2 | Term | Relapsing-remitting multiple sclerosis |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
|
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 |
The primary objective of the study is to investigate whether Peg-IFN beta-1a improves patients’ satisfaction in RRMS subjects unsatisfied with other injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), across a 12-weeks observation period. |
Valutare se il trattamento con Peg-IFN beta-1a migliora la soddisfazione correlata alla convenience del paziente affetto da RRMS, insoddisfatto della terapia con altri interferoni iniettabili sottocute, misurata mediante il questionario Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM- 9) somministrato a 12 settimane di trattamento con Peg-IFN. |
|
E.2.2 | Secondary objectives of the trial |
The secondary objectives of this study consist in the evaluation, in this study population, of the following parameters: •effects of Peg-IFN beta-1a treatment on patients’ satisfaction at 24 weeks; •effects of Peg-IFN beta-1a treatment on short-term patients’ adherence; •impact of Peg-IFN beta-1a treatment on patient-reported health-related quality of life; •effects of Peg-IFN beta-1a treatment on patients’ fatigue; •impact of Peg-IFN beta-1a treatment on patients’ injection-system satisfaction; •effects of Peg-IFN beta-1a on disease activity and physical disability; •relationship between patients’ satisfaction and adherence; •relationship between patients’ satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (ARR, disability, etc.)
|
•Valutare gli effetti del trattamento con Peg-IFN beta-1a -sulla soddisfazione generale del paziente al trattamento a 24 settimane; -sulla aderenza al trattamento a breve termine; -sulla fatigue percepita dal paziente; -sulle ricadute e sulla disabilità fisica del paziente;
•Valutare l’impatto del trattamento con Peg-IFN beta-1a -sulla qualità di vita del paziente; -sulla soddisfazione del paziente nei confronti del sistema di iniezione utilizzato;
•Valutare la correlazione tra la soddisfazione del paziente e l'aderenza al trattamento;
•Valutare la correlazione tra la soddisfazione del paziente e fattori socio-demografici (età, sesso, occupazione, livello di istruzione, ecc) e caratteristiche cliniche (tasso annualizzato di recidive (ARR), livello di disabilità,).
•Valutare la tollerabilità al trattamento e la sicurezza.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18 < Age < 65 years RRMS as per 2010 McDonald criteria Baseline EDSS between 0.0 and 5.0 Treatment with injectable subcutaneous Interferons with score < 58 in the “convenience satisfaction” domain of TSQM-9 Signed informed consent Period of stability from last relapse of at least 30 days before the baseline visit. Treatment with intravenous corticosteroids completed at least 30 days before the baseline visit (assumption of oral cortisone allowed as long as within 4 mg per day for no longer than 3 days).
|
-Età ≥ 18 e ≤65 anni; -Diagnosi di Sclerosi multipla recidivante-remittente secondo i criteri McDonald (2010); -Stato di disabilità secondo la scala (EDDS) con punteggio compreso tra 0.0 e 5.0; -Punteggio del questionario TSQM9 nel dominio della convenienza < 58 relativamente al trattamento in corso con interferoni iniettabili sottocute; - Consenso informato firmato; - Periodo di stabilità dall'ultima ricaduta di almeno 30 giorni prima della visita basale; -Trattamento con corticosteroidi per via endovenosa completato almeno 30 giorni prima della visita basale (l’assunzione di cortisone orale è consentita fino a 4 mg al giorno per non più di 3 giorni).
|
|
E.4 | Principal exclusion criteria |
Pregnancy or breast-feeding Depression or other psychiatric disorders Unwillingness or inability to comply with the protocol requirements Any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics
|
Gravidanza o allattamento; -Depressione o altre patologie psichiatriche; -Indisponibilità o incapacità a seguire le procedure previste dal protocollo a giudizio del medico; - Eventuali controindicazioni al trattamento con interferone beta-1a secondo quanto riportato nel Riassunto delle Caratteristiche del Prodotto.
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Changes from baseline in the score of convenience satisfaction domain of TSQM-9 at 12 weeks |
Variazione del punteggio relativo al dominio sulla convenience del questionario TSQM-9 a 12 settimane rispetto al basale |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Changes from baseline in the score of all domains of TSQM-9 at 24 weeks; -Changes from baseline in clinical measures (ARR, percentage of relapse-free patients, EDSS) measures at week 24. -Incidence and severity of adverse events occurred during the study (including local tolerance to treatment at the injection site). -Abnormalities in laboratory values. |
-Variazione del punteggio di tutti i domini del questionario TSQM-9 a 24 settimane rispetto al basale; -Variazione delle caratteristiche cliniche (ARR, percentuale di pazienti liberi da recidiva, EDSS) a 24 settimane rispetto al basale; -Incidenza e gravità degli Eventi Avversi avvenuti durante lo studio (inclusa la tollerabilità locale al trattamento nel sito di iniezione); -Anormalità dei parametri di laboratorio. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 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 | Yes |
E.6.13.1 | Other scope of the trial description |
Patient satisfaction and life-quality |
Grado di soddisfazione del paziente e qualità della vita |
|
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.8.2.4 | 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 | 35 |
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 | No |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |