Multiple Sclerosis Clinical Trial
A Study to Evaluate the Safety, Tolerability, and Efficacy of BIIB017 (Peginterferon Beta-1a) in Pediatric Participants for the Treatment of Relapsing-Remitting Multiple Sclerosis
Summary
This 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. In Part 2, the study will evaluate the long-term safety of BIIB017 and further describe safety and the long-term multiple sclerosis (MS) outcomes after BIIB017 treatment in participants who completed the study treatment at Week 96 in Part 1 of the study.
Eligibility Criteria
Key Inclusion Criteria:
Part 1:
Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS.
Must have an EDSS score between 0.0 and 5.5.
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).
Part 2:
• Participants who completed the study treatment in Part 1 (Week 96 Visit), as per protocol.
Key Exclusion Criteria:
Part 1:
Primary progressive, secondary progressive, or progressive relapsing. These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Participants with these conditions may also have superimposed relapses but are distinguished from relapsing participants by the lack of clinically stable periods or clinical improvement.
History of severe allergic or anaphylactic reactions or known drug hypersensitivity.
Known allergy to any component of Avonex or BIIB017 formulation.
Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the participant has not stabilized from a previous relapse prior to randomization (Day 1).
Any previous treatment with PEGylated human IFN β-1a.
Part 2:
Any significant changes in medical history occurring after enrollment in Part 1, including laboratory test abnormalities or current clinically significant conditions that, in the opinion of the Investigator, would have excluded the participant's participation in Part 1. The Investigator must re-assess the participant's medical fitness for participation and consider any factors that would preclude treatment.
The participant could not tolerate BIIB017 in Part 1.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply"
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There are 63 Locations for this study
San Diego California, 92121, United States More Info
Principal Investigator
Chapel Hill North Carolina, 27514, United States More Info
Principal Investigator
Norfolk Virginia, 23502, United States
Ciudad Autonoma de Buenos Aires Buenos Aires, C1181, Argentina More Info
Principal Investigator
Parkville Victoria, 3052, Australia
Gent East Flanders, 9000, Belgium More Info
Principal Investigator
Sofia , 1113, Bulgaria More Info
Principal Investigator
Split Dalmatia, 21000, Croatia More Info
Principal Investigator
Zagreb , 10000, Croatia More Info
Principal Investigator
Zagreb , 10000, Croatia More Info
Principal Investigator
Zagreb , 10000, Croatia More Info
Principal Investigator
Hradec Kralove , 50333, Czechia More Info
Principal Investigator
Strasbourg Bas Rhin, 67098, France More Info
Principal Investigator
Toulouse cedex 9 Haute Garonne, 31059, France More Info
Principal Investigator
Montpellier Herault, 34295, France More Info
Principal Investigator
Lille Nord, 59037, France More Info
Principal Investigator
Le Kremlin Bicêtre cedex Val De Marne, 94275, France More Info
Principal Investigator
Freiburg Baden Wuerttemberg, 79106, Germany More Info
Principal Investigator
Gottingen Niedersachsen, 37075, Germany More Info
Principal Investigator
Bochum Nordrhein Westfalen, 44791, Germany More Info
Principal Investigator
Berlin , 13353, Germany More Info
Principal Investigator
Larissa Thessaly, 41110, Greece More Info
Principal Investigator
Marousi , 15123, Greece
Thessaloniki , 54642, Greece More Info
Principal Investigator
Pecs Baranya, 7623, Hungary More Info
Principal Investigator
Debrecen Hajdú-Bihar, 4032, Hungary More Info
Principal Investigator
Jerusalem Levant, 91120, Israel More Info
Principal Investigator
Petach-Tikva Tel Aviv, 49202, Israel More Info
Principal Investigator
Napoli Campania, 80138, Italy More Info
Principal Investigator
Firenze , 50139, Italy More Info
Principal Investigator
Napoli , 80131, Italy More Info
Principal Investigator
Lisboa Lisbon, 1649-, Portugal More Info
Principal Investigator
Loures Lisbon, 2674-, Portugal More Info
Principal Investigator
Coimbra , 3000-, Portugal More Info
Principal Investigator
Porto , 4099-, Portugal More Info
Principal Investigator
Ufa Bashkortostan, 45007, Russian Federation
Krasnoyarsk Krasnoyarsk Krai, 66003, Russian Federation
St. Petersburg Leningrad, 19711, Russian Federation
Tomsk Oblast, 63400, Russian Federation
Kemerovo Siberia, 65006, Russian Federation
Belgorod , 30800, Russian Federation
Moscow , 11960, Russian Federation
Moscow , 12911, Russian Federation
Rostov-on-Don , 34402, Russian Federation
Yaroslavl , 15000, Russian Federation
Jeddah Makkah, 40047, Saudi Arabia More Info
Principal Investigator
Belgrade Balkans, 11000, Serbia More Info
Principal Investigator
Belgrade Balkans, 11000, Serbia More Info
Principal Investigator
Belgrade Balkans, 11070, Serbia More Info
Principal Investigator
Bratislava , 83340, Slovakia More Info
Principal Investigator
Esplugues de Llobregat Barcelona, 08950, Spain More Info
Principal Investigator
El Palmar Murcia, 30120, Spain More Info
Principal Investigator
Cordoba , 14004, Spain More Info
Principal Investigator
Madrid , 28034, Spain More Info
Principal Investigator
Ankara , 06500, Turkey More Info
Principal Investigator
Antalya , 07059, Turkey More Info
Principal Investigator
Izmir , 35210, Turkey More Info
Principal Investigator
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