Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||10 Years - 18 Years|
More Inclusion & Exclusion Criteria
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).
Exclusion Criteria:Part 1:
- - Primary progressive, secondary progressive, or progressive relapsing.
- - 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.
- - 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 participant could not tolerate BIIB017 in Part 1.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Biogen|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Argentina, Australia, Belgium, Bulgaria, Croatia, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Kuwait, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Tunisia, Turkey, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Multiple Sclerosis, Relapsing-Remitting|
Arms & Interventions
Experimental: BIIB017 (peginterferon beta-1a)
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. Participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.
Active Comparator: Avonex
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. Participants who enter optional Part 2 of the study will receive 125 μg SC injections of BIIB017 every 2 weeks for 96 Weeks.
Drug: - BIIB017 (peginterferon beta-1a)
Administered as specified in the treatment arm
Drug: - Interferon beta type 1a
Administered as specified in the treatment arm
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.