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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03958877
Registration number
NCT03958877
Ethics application status
Date submitted
20/05/2019
Date registered
22/05/2019
Titles & IDs
Public title
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
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Scientific title
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
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Secondary ID [1]
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2018-003008-38
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Secondary ID [2]
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105MS306
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting
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0
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BIIB017 (peginterferon beta-1a)
Treatment: Drugs - Interferon beta type 1a
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. Eligible 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. Eligible participants who enter optional Part 2 of the study will receive 125 µg SC injections of BIIB017 every 2 weeks for 96 Weeks.
Treatment: Drugs: BIIB017 (peginterferon beta-1a)
Administered as specified in the treatment arm
Treatment: Drugs: Interferon beta type 1a
Administered as specified in the treatment arm
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Part 1: Annualized Relapse Rate (ARR) at Week 48
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Assessment method [1]
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A multiple sclerosis (MS) relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. ARR is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
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Timepoint [1]
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Week 48
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Primary outcome [2]
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Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs Leading to Study Treatment Discontinuation
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Assessment method [2]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
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Timepoint [2]
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From Week 96 to Week 196
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Secondary outcome [1]
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Part 1: ARR at Week 96
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Assessment method [1]
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An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. ARR is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
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Timepoint [1]
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Week 96
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Secondary outcome [2]
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Part 1: Percentage of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans at Weeks 24, 48, and 96
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Assessment method [2]
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Timepoint [2]
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Weeks 24, 48, and 96
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Secondary outcome [3]
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Part 1: Percentage of Participants Free of New MRI Activity in the Brain (Free of Gadolinium [Gd]-Enhancing Lesions and New or Newly Enlarging T2 Hyperintense Lesions) at Weeks 24, 48, and 96
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Assessment method [3]
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Timepoint [3]
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Weeks 24, 48, and 96
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Secondary outcome [4]
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Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96
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Assessment method [4]
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Timepoint [4]
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Weeks 24, 48, and 96
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Secondary outcome [5]
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Part 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96
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Assessment method [5]
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Timepoint [5]
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Weeks 24, 48, and 96
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Secondary outcome [6]
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Part 1: Time to First Relapse
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Assessment method [6]
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Timepoint [6]
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Up to Week 96
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Secondary outcome [7]
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Part 1: Percentage of Participants Free of Relapse at Weeks 48 and 96
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Assessment method [7]
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Timepoint [7]
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Weeks 48 and 96
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Secondary outcome [8]
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Part 1: Change from Baseline in Cognition at Weeks 24, 48, 72, and 96 as Measured by the Symbol Digit Modality Test (SDMT)
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Assessment method [8]
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The SDMT measures the time to pair abstract symbols with specific numbers. The test requires elements of attention, visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items from 0 (worst) to 110 (best) in 90 seconds. The total score provides a measure of the speed and accuracy of symbol-digit substitution. Higher scores indicate better performance.
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Timepoint [8]
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Baseline, Weeks 24, 48, 72, and 96
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Secondary outcome [9]
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Part 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96
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Assessment method [9]
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EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS).
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Timepoint [9]
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Baseline, Weeks 48, and 96
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Secondary outcome [10]
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Part 1: Change from Baseline in the Quality of Life as Measured by the Pediatric Quality of Life Inventory (PedsQL) at Weeks 24, 48, 72 and 96
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Assessment method [10]
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The PedsQL consists of 23 items in four generic score scales: physical functioning, emotional functioning, social functioning, and school functioning that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
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Timepoint [10]
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Baseline, Weeks 24, 48, 72 and 96
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Secondary outcome [11]
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Part 1: Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017
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Assessment method [11]
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Timepoint [11]
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Within 8 hours postdose on Day 1 of Week 1; Within 8 hours, 48 and 120 hours postdose on Day 1 of Week 4; Within 8 hours postdose on Day 1 of Week 24
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Secondary outcome [12]
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Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State for BIIB017
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Assessment method [12]
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Timepoint [12]
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Within 8 hours postdose on Day 1 of Week 1; Within 8 hours, 48 and 120 hours postdose on Day 1 of Week 4; Within 8 hours postdose on Day 1 of Week 24
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Secondary outcome [13]
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Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State for BIIB017
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Assessment method [13]
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Timepoint [13]
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Within 8 hours postdose on Day 1 of Week 1; Within 8 hours, 48 and 120 hours postdose on Day 1 of Week 4; Within 8 hours postdose on Day 1 of Week 24
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Secondary outcome [14]
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Part 1: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation
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Assessment method [14]
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An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose results in death, is a life-threatening event, requires inpatient hospitalization or prolongation of existing hospitalization, results in a significant disability/incapacity or congenital anomaly, or is a medically important event.
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Timepoint [14]
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Up to Week 100
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Secondary outcome [15]
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Part 1: Change from Baseline in Height at Weeks 24, 48, 72, 96, and 100
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Assessment method [15]
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Timepoint [15]
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Baseline, Weeks 24, 48, 72, 96, and 100
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Secondary outcome [16]
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Part 1: Change from Baseline in Weight at Weeks 24, 48, 72, 96, and 100
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Assessment method [16]
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Timepoint [16]
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Baseline, Weeks 24, 48, 72, 96, and 100
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Secondary outcome [17]
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Part 1: Change from Baseline in Tanner Score at Weeks 24, 48, 72, 96, and 100
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Assessment method [17]
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Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age less than (\<) 16 years and for female participants who are pre-menarche and have a bone age \< 16 years and will be stopped once the participant's bone age reaches greater than or equal to (\>=) 16 years or (once the participant is post-menarche. Tanner Score can be omitted if required by country-specific regulations and/or local ethics committees.
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Timepoint [17]
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Baseline, Weeks 24, 48, 72, 96, and 100
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Secondary outcome [18]
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Part 1: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN ß-1a) [All Participants]
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Assessment method [18]
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Presence of IFN ß-1a antibodies in human serum will be determined using enzyme-linked immunosorbent assay (ELISA) followed by further characterization and titration of positive samples in a cell-based neutralizing antibody assay.
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Timepoint [18]
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Up to Week 96
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Secondary outcome [19]
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Part 1: Number of Participants With Binding Antibodies to Peginterferon (PEG) [BIIB017-Treated Participants]
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Assessment method [19]
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Anti-PEG binding antibodies in human serum will be determined using an ELISA.
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Timepoint [19]
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Up to Week 96
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Secondary outcome [20]
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Part 1: Change from Baseline in Depression as Assessed by Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Assessment method [20]
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MINI-KID is a short (approximately 15 minute) structured diagnostic interview used to assess the presence of 20 diagnostic and statistical manual of mental disorders, 4th Edition (DSM-IV) child and adolescent psychiatric disorders as well as the risk of suicide. The MINI-Kid frames questions in language that is easy for children and adolescents. It consists of 137 questions across 24 modules.
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Timepoint [20]
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Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Secondary outcome [21]
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Part 1: Change from Baseline in Blood Pressure at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Assessment method [21]
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Timepoint [21]
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Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Secondary outcome [22]
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Part 1: Change from Baseline in Pulse Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Assessment method [22]
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Timepoint [22]
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Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Secondary outcome [23]
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Part 1: Change from Baseline in Body Temperature at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Assessment method [23]
0
0
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Timepoint [23]
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Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Secondary outcome [24]
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Part 1: Change from Baseline in Respiratory Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Assessment method [24]
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0
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Timepoint [24]
0
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Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Secondary outcome [25]
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Part 1: Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96, and 100
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Assessment method [25]
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Timepoint [25]
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Baseline (Before dosing), Weeks 48, 96, and 100
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Secondary outcome [26]
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Part 1: Percentage of Participants with Changes Over Time in Clinical Laboratory Values
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Assessment method [26]
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Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.
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Timepoint [26]
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Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100
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Secondary outcome [27]
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Part 2: ARR at Weeks 144 and 192
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Assessment method [27]
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An MS relapse is defined as the onset of new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings. ARR is calculated as the total number of relapses in each treatment group adjusted for the duration of study treatment in person-years.
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Timepoint [27]
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Weeks 144 and 192
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Secondary outcome [28]
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Part 2: Change from Baseline in EDSS Score at Weeks 120, 144, 168, 192, and 196
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Assessment method [28]
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EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in MS. Scores range from 0.0 (normal) to 10.0 (death due to MS).
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Timepoint [28]
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Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [29]
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Part 2: Change from Baseline in Height at Weeks 120, 144, 168, 192, and 196
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Assessment method [29]
0
0
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Timepoint [29]
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Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [30]
0
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Part 2: Change from Baseline in Weight at Weeks 120, 144, 168, 192, and 196
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Assessment method [30]
0
0
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Timepoint [30]
0
0
Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [31]
0
0
Part 2: Change from Baseline in Tanner Score at Weeks 120, 144, 168, 192, and 196
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Assessment method [31]
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Assessment of Tanner stages (a scale of physical development) will be performed by a medical doctor experienced with this assessment. Tanner score ranges from Stage 1 (childhood) to Stage 5 (full physical maturity). Information regarding Tanner staging will be collected for all male participants with bone age \< 16 years and for female participants who are pre-menarche and have a bone age \<16 years and will be stopped once the participant's bone age reaches \>= 16 years or (once the participant is post-menarche. Tanner Score can be omitted if required by country-specific regulations and/or local ethics committees.
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Timepoint [31]
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Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [32]
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Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN ß-1a (All Participants)
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Assessment method [32]
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Presence of IFN ß-1a antibodies in human serum will be determined using ELISA followed by further characterization and titration of positive samples in a cell-based neutralizing antibody assay.
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Timepoint [32]
0
0
Up to Week 192
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Secondary outcome [33]
0
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Part 2: Number of Participants With Binding Antibodies to PEG (BIIB017-Treated Participants)
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Assessment method [33]
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0
Anti-PEG binding antibodies in human serum will be determined using an ELISA.
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Timepoint [33]
0
0
Up to Week 192
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Secondary outcome [34]
0
0
Part 2: Change from Baseline in Blood Pressure at Weeks 120,144,168, 192, and 196
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Assessment method [34]
0
0
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Timepoint [34]
0
0
Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [35]
0
0
Part 2: Change from Baseline in Pulse Rate at Weeks 120, 144, 168, 192, and 196
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Assessment method [35]
0
0
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Timepoint [35]
0
0
Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [36]
0
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Part 2: Change from Baseline in Body Temperature at Weeks 120, 144, 168, 192, and 196
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Assessment method [36]
0
0
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Timepoint [36]
0
0
Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [37]
0
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Part 2: Change from Baseline in Respiratory Rate at Weeks 120, 144, 168, 192, and 196
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Assessment method [37]
0
0
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Timepoint [37]
0
0
Baseline (Week 96), Weeks 120, 144, 168, 192, and 196
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Secondary outcome [38]
0
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Part 2: Change from Baseline in 12-Lead ECG Parameters at Weeks 144, 192, and 196
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Assessment method [38]
0
0
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Timepoint [38]
0
0
Baseline (Week 96), Weeks 144, 192, and 196
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Secondary outcome [39]
0
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Part 2: Change from Baseline in Depression as Assessed by Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at Weeks 108, 120, 132, 144,156, 168, 180, 192, and 196
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Assessment method [39]
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0
MINI-KID is a structured diagnostic interview instrument for psychiatric evaluation and outcome tracking. All questions are answered Yes or No.
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Timepoint [39]
0
0
Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192, and 196
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Secondary outcome [40]
0
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Part 2: Percentage of Participants with Changes Over Time in Clinical Laboratory Values
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Assessment method [40]
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Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.
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Timepoint [40]
0
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Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192, and 196
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Eligibility
Key inclusion criteria
Key
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.
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Minimum age
10
Years
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Maximum age
18
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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 ß-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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/10/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
20/05/2027
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Actual
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Sample size
Target
142
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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0
Royal Children's Hospital - Parkville
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Recruitment postcode(s) [1]
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0
3052 - Parkville
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Recruitment outside Australia
Country [1]
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0
United States of America
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State/province [1]
0
0
California
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Country [2]
0
0
United States of America
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State/province [2]
0
0
North Carolina
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Virginia
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Country [4]
0
0
Argentina
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State/province [4]
0
0
Buenos Aires
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Country [5]
0
0
Belgium
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State/province [5]
0
0
East Flanders
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Country [6]
0
0
Belgium
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State/province [6]
0
0
Wallonia
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Country [7]
0
0
Bulgaria
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State/province [7]
0
0
Sofia
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Country [8]
0
0
Croatia
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State/province [8]
0
0
Dalmatia
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Country [9]
0
0
Croatia
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State/province [9]
0
0
Zagreb
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Country [10]
0
0
Czechia
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State/province [10]
0
0
Hradec Kralove
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Country [11]
0
0
France
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State/province [11]
0
0
Bas Rhin
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Country [12]
0
0
France
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State/province [12]
0
0
Haute Garonne
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Country [13]
0
0
France
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State/province [13]
0
0
Herault
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Country [14]
0
0
France
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State/province [14]
0
0
Nord
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Country [15]
0
0
France
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State/province [15]
0
0
Val De Marne
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Country [16]
0
0
Germany
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State/province [16]
0
0
Baden Wuerttemberg
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Country [17]
0
0
Germany
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State/province [17]
0
0
Niedersachsen
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Country [18]
0
0
Germany
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State/province [18]
0
0
Nordrhein Westfalen
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Country [19]
0
0
Germany
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State/province [19]
0
0
Berlin
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Country [20]
0
0
Greece
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State/province [20]
0
0
Thessaly
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Samsun
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Biogen
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/study/NCT03958877
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Contacts
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Medical Director
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Biogen
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Contact person for public queries
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US Biogen Clinical Trial Center
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866-633-4636
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT03958877