Relapsing Remitting Multiple Sclerosis (RRMS) MedDRA version: 20.0 Level: SOC Classification code 10029205 Term: Nervous system disorders System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: PT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Plegridy
Product Name: Plegridy
Product Code: BIIB017
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: PEGINTERFERON BETA-1A
CAS Number: 1211327-92-2
Curr
Sponsors
Biogen Idec Research Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Part 1 1. Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS [Krupp 2013; Polman 2011]. 2. Must have an EDSS score between 0.0 and 5.5. 3. 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 Subjects who completed the study treatment in Part 1 (Week 96 Visit), as per protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 142 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: PART 1 1. Primary progressive, secondary progressive, or progressive relapsing MS .These conditions require the presence of continuous clinical disease worsening over a period of at least 3 months. Subjects with these conditions may also have superimposed relapses but are distinguished from relapsing subjects by the lack of clinically stable periods or clinical improvement. 2. Occurrence of an MS relapse that has occurred within 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization (Day 1). 3. History of severe allergic or anaphylactic reactions or known drug hypersensitivity. 4. Known allergy to any component of Avonex or BIIB017 formulation. 5. Any previous treatment with PEGylated human IFN ß-1a. PART 2 1. 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 subject's participation in Part 1. The Investigator must re-assess the subject's medical fitness for participation and consider any factors that would preclude treatment. 2. The subject could not tolerate BIIB017 in Part 1. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: ;Primary end point(s): #1: Part 1: the annualized relapse rate (ARR) at Week 48. #2: Part 2: Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs) and AEs leading to Study Treatment Discontinuation. ;Timepoint(s) of evaluation of this end point: #1: week 48 #2: Week 96 to Week 196 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PART 1: #3: ARR at Week 96 #4: percentage of subjects free of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans at Weeks 24, 48, and 96 #5: percentage of subjects 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 #6: Number of New or Nely Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48 and 96 #7: Number of GD-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48 and 96 #8: Time to First Relapse (timeframe up to week 96) #9: Percentage of Participants Free of Relapse at Weeks 48 and 96 (Timeframe weeks 48 and 96) #10: Change from Baseline in Cognition at Weeks 24, 28, 72 and 96 as Measured by the Symbol Digit Modality Test (SDMT) #11: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96 #12: Change from Baseline in the Quality of Life as Measured by the Pediatric Quality of Live Inventory (PedsQL) at Weeks 24, 48, 72 and 96. #13: Area Under the Plasma Concentration – Time Cruve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017 #14: Maximum Observed Plasma Concentration (Cmax) at Steady State for BIIB017 #15: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State for BIIB017 #16: Percentage of Participants with Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation #17: Change from Baseline in Height at Weeks 24, 48, 72, 96 and 100 #18: Change from Baseline in Weight at Weeks 24, 48, 72, 96 and 100 #19: Change from Baseline in Tanner Score at Weeks 24, 48, 72, 96 and 100 #20: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN ß-1a) #21: Number of Participants with Binding Antibodies to Peginterferon (PEG) [BIIB017-Treated Participants] #22: Change from Baseline in Depression as Assessed by Mini International | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Croatia, Czechia, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Kuwait, Mexico, Portugal, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Tunisia, Türkiye, United States
Contacts
Public Contact105MS306 Clinical Trial Team
Biogen Idec Research Limited
Outcome results
None listed