Relapsing-remitting multiple sclerosis with paediatric onset MedDRA version: 20.1 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Copaxone 40 mg/ml solution for injection, pre-filled syringe
Pharmaceutical Form: Suspension for injection in pre-filled syringe
INN or Proposed INN: Glatiramer Acetate
CAS Number: 147245-
Sponsors
Università degli Studi Aldo Moro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of POMS [23,24] • Male and female children and adolescents aged between 10 to 17 years included at the time of informed consent (i.e. have not yet had their 18th birthday at randomization); • Treatment naïve; • Signed and dated informed consent from parents/legal representative; • Relapsing remitting course; • At least one MS relapse during the previous year; • EDSS score of 0 to 5.5, inclusive • Subjects of childbearing potential who are sexually active must be willing to practice effective contraception during the study. Are the trial subjects under 18? yes Number of subjects for this age range: 142 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients with progressive MS; • Patients with an active, chronic disease of the immune system other than MS; • Patients meeting the definition of Acute Disseminated Encephalomyelitis (ADEM); • Patients with thyroid dysfunction; • Patients with severe renal insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to demonstrate the equivalence of two of injectable drugs (IFN beta 1a 30-mcg im weekly and GA 40 mg s.c. e.o.d.) currently used for the treatment of POMS or the superiority of one of them on MRI and clinical effectiveness outcomes.;Secondary Objective: Secondary objectives are to compare safety and cost-effectiveness of the two drugs.;Primary end point(s): Proportion of subjects free of new or newly enlarging T2 hyperintense on brain MRI scans at 96 weeks.;Timepoint(s) of evaluation of this end point: As above | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints: • Annualized relapse rate (ARR) at Weeks 48 and 96; • Proportion of subjects free of relapse up to Week 96; • Time to first relapse; • Time to disability progression defined as 1-point increase of the Expanded Disability Status Scale (EDSS) score confirmed at Week 24; • Number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Weeks 48 and 96; • Number of MRI T1 Gd-enhancing lesions on brain MRI scans at Weeks 48 and 96; • Change of Symbol Digit Modality test (SDMT) at Weeks 48 and 96; • Change of Fatigue (FS) score at Weeks 48 and 96; • Change of QOL (ped QOL) evaluated through Patient Reported Outcomes (PROs) at Weeks 48 and 96; • Cost-efficacy analyses. An estimate of the cost-effectiveness of the therapeutic regimens under examination. Safety endpoint: • Frequency and type of Adverse Events (AEs) during all the study ;Timepoint(s) of evaluation of this end point: As above | — |
Countries
Italy
Contacts
Public ContactLucia Margari
Università degli Studi Aldo Moro
Outcome results
None listed