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Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis.

Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis.
CompletedPhase 3Relapsing MS2017-005129-18

What it found

Missed its main goal

The main measure did not show a significant benefit.

“MRI disease activity-free status did not differ (p = 0.09).”
Read by software from the paper's abstract

MRI disease activity-free status

p = 0.09

Total participants: 30

Read by software from the paper's abstract

What was tested

Treatment tested

What it measured

Main measures

  • Proportion of subjects free of new or newly enlarging T2 hyperintense on brain MRI scans at 96 weeks.

    MRI lesions

Other measures (1)

  • Efficacy endpoints:

Who could take part

Relapsing MS

Inclusion: • Diagnosis of POMS [23,24] Exclusion: • Patients with progressive MS;

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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Related trials

History

    1. Started

      Mar 2018

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