Relapsing Remitting Multiple Sclerosis (RRMS)
Conditions
Brief summary
Part 1: the annualized relapse rate (ARR) at Week 48., Part 2: Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to Study Treatment Discontinuation. [From Week 96 to week 196]
Detailed description
[Part I] ARR at week 48, [Part I] 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, [Part I] 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, [Part I] Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96, [Part I] Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96, [Part I] Time to First Relapse (timeframe: Up to week 96)., [Part I] Percentage of Participants Free of Relapse at Weeks 48 and 96., [Part I] Change from Baseline in Cognition at Weeks 24, 48, 72, and 96 as Measured by the Symbol Digit Modality Test (SDMT), [Part I] Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96, [Part I] 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, [Part I] Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017. [Time Frame: 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], [Part I] Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State for BIIB017 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, [Part I] Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State for BIIB017 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, [Part I] Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation (timeframe up to week 100), [Part I] Change from Baseline in Height at Weeks 24, 48, 72, 96, and 100, [Part I] Change from Baseline in Weight at Weeks 24, 48, 72, 96, and 100, [Part I] Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN β-1a) [All Participants] [Time Frame: Up to Week 96], [Part I] Number of Participants With Binding Antibodies to Peginterferon (PEG) [BIIB017-Treated Participants] Anti-PEG binding antibodies in human serum will be determined using an ELISA (Timeframe: Up to Week 96), [Part I] 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, [Part I] Change from Baseline in Blood Pressure at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 10, [Part I] Change from Baseline in Pulse Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100, [Part I] Change from Baseline in Body Temperature at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100, [Part I] Change from Baseline in Respiratory Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100, [Part I] Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96, and 100, [Part I] Percentage of Participants with Changes Over Time in Clinical Laboratory Values at Baseline & Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96, and 100, Part 2: ARR at Weeks 144 and 192, Part 2: Change from Baseline in EDSS Score at Weeks 120, 144, 168, 192, and 196, Part 2: Change from Baseline in Height at Weeks 120, 144, 168, 192, and 196, Part 2: Change from Baseline in Weight at Weeks 120, 144, 168, 192, and 196, Part 2: Change from Baseline in Tanner Score at Weeks 120, 144, 168, 192, and 196, Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN β-1a (All Participants) (Time Frame: Up to week 192), Part 2: Number of Participants With Binding Antibodies to PEG (BIIB017-Treated Participants) (Time Frame: Up to week 192), Part 2: Change from Baseline in Blood Pressure at Weeks 120,144,168, 192, and 196, Part 2: Change from Baseline in Pulse Rate at Weeks 120, 144, 168, 192, and 196, Part 2: Change from Baseline in Body Temperature at Weeks 120, 144, 168, 192, and 196, Part 2: Change from Baseline in Respiratory Rate at Weeks 120, 144, 168, 192, and 196, Part 2: Change from Baseline in 12-Lead ECG Parameters at Weeks 144, 192, and 196, 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, Part 2: Percentage of Participants with Changes Over Time in Clinical Laboratory Values at Baseline & (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192, and 196
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: the annualized relapse rate (ARR) at Week 48., Part 2: Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to Study Treatment Discontinuation. [From Week 96 to week 196] | — |
Secondary
| Measure | Time frame |
|---|---|
| [Part I] ARR at week 48, [Part I] 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, [Part I] 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, [Part I] Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96, [Part I] Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96, [Part I] Time to First Relapse (timeframe: Up to week 96)., [Part I] Percentage of Participants Free of Relapse at Weeks 48 and 96., [Part I] Change from Baseline in Cognition at Weeks 24, 48, 72, and 96 as Measured by the Symbol Digit Modality Test (SDMT), [Part I] Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96, [Part I] Change from Baseline in the Quality of Life as Meas | — |
Countries
Bulgaria, Croatia, Czechia, Hungary, Slovakia