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Research summary · AI summary · not yet reviewedHuman studyPhase 3Trial registry
Evaluation of BIIB017 in Pediatric Subjects with Relapsing-Remitting Multiple Sclerosis
The study is designed to evaluate the safety, tolerability, and efficacy of BIIB017 (peginterferon beta-1a) in children aged 10 to less than 18 with relapsing-remitting multiple sclerosis (RRMS) over 96 weeks, comparing it to Avonex. The main goal is to assess the annualized relapse rate at Week 48, with additional long-term safety and outcome evaluations in a follow-up phase.
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This plain-English summary was written by AI from a published abstract and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
Why it matters
This research seeks to address an important gap in MS treatment options for pediatric patients, who may respond differently to therapies compared to adults.
What this does not prove
No results have been posted yet, and the planned enrolment and endpoints do not constitute findings.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- Not reported
- Controlled
- Yes
- Primary endpoint met
- Not reported
- Relevant MS type
- RRMS
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (9)
study phase"eligibilityCriteria": "Key Inclusion Criteria:\n\nPart 1:\n\n* Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS.\n* Must have an EDSS score between 0.0 and 5.5.\n* Must have experienced \\>= 1 relapse in the 12 months prior to randomization (Day 1) or \\>= 2 relapses in the 24 months prior to randomization (Day 1) or have evidence of asymptomatic disease activity (Gd-enhancing lesions) on brain MRI in the 6 months prior to randomization (Day 1).\n\nPart 2:\n\n• Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.\n\nKey Exclusion Criteria:\n\nPart 1:\n\n* Primary progressive, secondary progressive, or progressive relapsing MS.
subjects"officialTitle": "An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension"
controlled"officialTitle": "An Open-Label, Randomized, Multicenter, Active-Controlled, Parallel-Group Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 in Pediatric Subjects Aged 10 to Less Than 18 Years for the Treatment of Relapsing-Remitting Multiple Sclerosis, With Optional Open-Label Extension"
relevant ms types"Multiple Sclerosis, Relapsing-Remitting"
intervention"description": "Participants will receive subcutaneous (SC) injection of BIIB017 (peginterferon beta-1a) 63 microgram (μg) on Day 1, followed by 94 μg at Week 2, followed by 125 μg at Week 4, and then 125 μg SC injection every 2 weeks up to Week 96 in Part 1 of the study.
comparator"description": "Participants will receive Avonex (interferon beta type 1a) starting at a dose of 7.5 μg on Day 1, followed by an increase of 7.5 μg each week for 3 weeks, followed by 30 μg intramuscular (IM) injections every week up to Week 96 in Part 1 of the study.
primary endpoint"measure": "Part 1: Annualized Relapse Rate (ARR) at Week 48",
findingsThis study will evaluate the safety, tolerability, and descriptive efficacy of BIIB017 in pediatric participants with relapsing-remitting multiple sclerosis (RRMS) and to assess the pharmacokinetics (PK) of BIIB017 in pediatric participants with RRMS in Part 1.
limitationsNo results are posted. Planned enrolment and endpoints are not findings.
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