Multi-centre, prospective/retrospective, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN beta-1a) administered weekly i.m. and glatiramer-acetate (GA) in pediatric patients affected by multiple sclerosis.
SYNOPSIS AND RESULTS
This study is a Phase IIIb, 36-month multi-centre, interventional prospetic/retrospective, pragmatic, open label, randomised trial to evaluate the effectiveness and safety of Glatiramer Acetate (GA) compared to Interferon beta-1a (INF beta-1a) in children/adolescent patients aged 12-17 (i.e. have not yet had their 18th birthday at randomisation) with Multiple Sclerosis (MS). The study consists of a combined prospective and retrospective design. Prospective approach: clinical, cognitive, behavioural and Magnetic Resonance Imaging (MRI) data will be collected at the baseline and at each follow-up visit; these data will be included into the Italian MS Register. Clinical evaluation will be performed at baseline and every six months and it will include: complete medical history, physical and neurological examination, with disability assessed by the Expanded Disability Status Scale (EDSS), annualised relapse rate (including the year prior randomisation), quality of life measured by the Pediatric Quality of Life (PQoL) scale, fatigue assessed by the Fatigue Severity Scale (FSS), vital signs, haematological/blood chemistry, the occurrence of severe adverse events (SAEs) and Adverse Events (AEs), urinalysis and pregnancy test (beta hCG). Brain MRI scan (by 1.5 T MRI) cognitive function assessment, using the Symbol Digit Modalities Test (SDMT) will be assessed at baseline and every 12 months. Retrospective approach: data from each patient will include retrospective information from the start of treatment (index date, baseline timepoint) until the follow-up visit. Data will be retrospectively collected from the Italian MS Register [all visits occurring as per clinical practice (every six months)] (max 3.000 characters)
Fondazione Italiana Sclerosi Multipla – FISM – Ente del Terzo Settore/ETS e, in forma abbreviata, FISM ETS. Iscrizione al RUNTS Rep. N° 89695 - Fondazione con Riconoscimento di Personalità Giuridica - C.F. 95051730109
Multi-centre, prospective/retrospective, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN beta-1a) administered weekly i.m. and glatiramer-acetate (GA) in pediatric patients affected by multiple sclerosis.
This study is a Phase IIIb, 36-month multi-centre, interventional prospetic/retrospective, pragmatic, open label, randomised trial to evaluate the effectiveness and safety of Glatiramer Acetate (GA) compared to Interferon beta-1a (INF beta-1a) in children/adolescent patients aged 12-17 (i.e. have not yet had their 18th birthday at randomisation) with Multiple Sclerosis (MS).
The study consists of a combined prospective and retrospective design.
Prospective approach: clinical, cognitive, behavioural and Magnetic Resonance Imaging (MRI) data will be collected at the baseline and at each follow-up visit; these data will be included into the Italian MS Register.
Clinical evaluation will be performed at baseline and every six months and it will include: complete medical history, physical and neurological examination, with disability assessed by the Expanded Disability Status Scale (EDSS), annualised relapse rate (including the year prior randomisation), quality of life measured by the Pediatric Quality of Life (PQoL) scale, fatigue assessed by the Fatigue Severity Scale (FSS), vital signs, haematological/blood chemistry, the occurrence of severe adverse events (SAEs) and Adverse Events (AEs), urinalysis and pregnancy test (beta hCG). Brain MRI scan (by 1.5 T MRI) cognitive function assessment, using the Symbol Digit Modalities Test (SDMT) will be assessed at baseline and every 12 months.
Retrospective approach: data from each patient will include retrospective information from the start of treatment (index date, baseline timepoint) until the follow-up visit. Data will be retrospectively collected from the Italian MS Register [all visits occurring as per clinical practice (every six months)]
(max 3.000 characters)
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