Back to results

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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

BIIB017 (peginterferon beta-1a)

Interferon beta type 1a

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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"

Sites / Locations

UC San Diego HealthRecruiting
UNC HospitalsRecruiting
Meridian Clinical Research
Hospital Italiano de Buenos AiresRecruiting
Royal Children's HospitalRecruiting
Universitair Ziekenhuis GentRecruiting
Clinique CHC MontLégiaRecruiting
MHATNP "Sv.Naum", EADRecruiting
University Hospital Centre SplitRecruiting
Children's Hospital ZagrebRecruiting
Clinical Hospital 'Sestre Milosrdnice'Recruiting
University Hospital Centre ZagrebRecruiting
Fakultni nemocnice Hradec KraloveRecruiting
CHU Strasbourg - Hôpital HautepierreRecruiting
Hopital PurpanRecruiting
Hopital Gui de ChauliacRecruiting
Hopital Roger Salengro - CHU LilleRecruiting
Hôpital BicêtreRecruiting
Universitaetsklinikum FreiburgRecruiting
Universitaetsmedizin GoettingenRecruiting
St. Josef-Hospital UniversitaetsklinikumRecruiting
Charité - Campus Virchow-KlinikumRecruiting
General Hospital of LarissaRecruiting
IASO Children's Hospital
General Hospital of Thessaloniki 'Hippokration'Recruiting
Pecsi TudomanyegyetemRecruiting
Debreceni EgyetemRecruiting
Semmelweis Egyetem AOKRecruiting
Hadassah University Hospital - Ein KeremRecruiting
Schneider Children's Medical CenterRecruiting
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"Recruiting
Azienda Ospedaliero Universitaria Ospedale Pediatrico MeyerRecruiting
Azienda Ospedaliera Universitaria 'Federico II'Recruiting
Ibn Sina HospitalRecruiting
Centro Hospitalar e Universitário Lisboa Norte E.P.E.Recruiting
Hospital Beatriz ÂngeloRecruiting
Hospital de BragaRecruiting
Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital PediátricoRecruiting
Centro Hospitalar do Porto, E.P.E. - Hospital de Santo AntónioRecruiting
SBEI HPE 'Bashkir State Medical University' of the MoH of the RF
FSBI "Federal Siberian Scientific-Clinical Center of FMBA"
LLC National center for socially significan disease
Nebbiolo LLC
SAIH 'Kemerovo Regional Clinical Hospital'
RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'
SBHI
SBIH of Moscow region "Moscow Regional Scientific & Research
SBEI HPE 'Rostov State Medical University' of the MoH of the RF
State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'
King Faisal Specialist Hospital & Research CenterRecruiting
King Saud UniversityRecruiting
Clinic of Neurology and Psychiatry for Children and YouthRecruiting
University Children's HospitalRecruiting
Mother and Child Health Care Institute of Serbia ''Dr Vukan Cupic''Recruiting
Narodny ustav detskych chorobRecruiting
Hospital Sant Joan de DeuRecruiting
Hospital Universitario Virgen de la ArrixacaRecruiting
Hospital Universitario Reina SofiaRecruiting
Hospital Universitario Ramon y CajalRecruiting
Hopital RaziRecruiting
Hôpital Fattouma BourghibaRecruiting
Hôpital Habib BourguibaRecruiting
Gazi University Medical Faculty Clinical Research UnitRecruiting
Akdeniz University Medical FacultyRecruiting
Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma HastanesiRecruiting
Ondokuz Mayis Univ. Med. Fac.Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BIIB017 (peginterferon beta-1a)

Avonex

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Part 1: Annualized Relapse Rate (ARR) at Week 96

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.

Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation

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.

Secondary Outcome Measures

Part 1: ARR at Week 48

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.

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

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

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96

Part 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96

Part 1: Time to First Relapse

Part 1: Percentage of Participants Free of Relapse Up to Week 96

Part 1: Change from Baseline in Cognition at Weeks 24, 48, 72 and 96 as Measured by the Symbol Digit Modality Test (SDMT)

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.

Part 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96

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).

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, 96 and 100

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.

Part 1: Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval (AUCtau) for BIIB017

Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State for BIIB017

Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State for BIIB017

Part 1: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation

Part 1: Change from Baseline in Height at Weeks 24, 48, 72, 96 and 100

Part 1: Change from Baseline in Weight at Weeks 24, 48, 72, 96 and 100

Part 1: Change from Baseline in Tanner Score at Weeks 24, 48, 72, 96 and 100

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.

Part 1: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN β-1a) [All Participants]

Presence of IFN β-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.

Part 1: 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.

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

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.

Part 1: Change from Baseline in Blood Pressure at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Part 1: Change from Baseline in Heart Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Part 1: Change from Baseline in Body Temperature at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Part 1: Change from Baseline in Respiratory Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Part 1: Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96 and 100

Part 1: Percentage of Participants with Changes Over Time in Clinical Laboratory Values

Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.

Part 2: ARR at Weeks 144 and 192

Part 2: Change from Baseline in EDSS Score at Weeks 120, 144, 168, 192 and 196

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).

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

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.

Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN β-1a (All Participants)

Presence of IFN β-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.

Part 2: Number of Participants With Binding Antibodies to PEG (BIIB017-Treated Participants)

Anti-PEG binding antibodies in human serum will be determined using an ELISA.

Part 2: Change from Baseline in Blood Pressure at Weeks 120,144,168,192 and 196

Part 2: Change from Baseline in Heart 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

MINI-KID is a structured diagnostic interview instrument for psychiatric evaluation and outcome tracking. All questions are answered Yes or No.

Part 2: Percentage of Participants with Changes Over Time in Clinical Laboratory Values

Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.

Full Information

NCT ID

NCT03958877

First Posted

May 20, 2019

Last Updated

April 3, 2023

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT03958877

Brief 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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 18, 2019 (Actual)

Primary Completion Date

November 5, 2029 (Anticipated)

Study Completion Date

November 5, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

142 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BIIB017 (peginterferon beta-1a)

Arm Type

Experimental

Arm Description

Arm Title

Avonex

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

BIIB017 (peginterferon beta-1a)

Other Intervention Name(s)

PLEGRIDY

Intervention Description

Administered as specified in the treatment arm

Intervention Type

Drug

Intervention Name(s)

Interferon beta type 1a

Other Intervention Name(s)

Avonex

Intervention Description

Administered as specified in the treatment arm

Primary Outcome Measure Information:

Title

Part 1: Annualized Relapse Rate (ARR) at Week 96

Description

Time Frame

Week 96

Title

Part 2: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation

Description

Time Frame

From Week 96 to Week 196

Secondary Outcome Measure Information:

Title

Part 1: ARR at Week 48

Description

Time Frame

Week 48

Title

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

Time Frame

Weeks 24, 48, and 96

Title

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

Time Frame

Weeks 24, 48, and 96

Title

Part 1: Number of New or Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans at Weeks 24, 48, and 96

Time Frame

Weeks 24, 48, and 96

Title

Part 1: Number of Gd-Enhancing Lesions on Brain MRI Scans at Weeks 24, 48, and 96

Time Frame

Weeks 24, 48, and 96

Title

Part 1: Time to First Relapse

Time Frame

Up to Week 96

Title

Part 1: Percentage of Participants Free of Relapse Up to Week 96

Time Frame

Up to Week 96

Title

Part 1: Change from Baseline in Cognition at Weeks 24, 48, 72 and 96 as Measured by the Symbol Digit Modality Test (SDMT)

Description

Time Frame

Baseline, Weeks 24, 48, 72 and 96

Title

Part 1: Change from Baseline in the Expanded Disability Status Scale (EDSS) Score at Weeks 48 and 96

Description

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).

Time Frame

Baseline, Weeks 48 and 96

Title

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, 96 and 100

Description

Time Frame

Baseline, Weeks 24, 48, 72, 96 and 100

Title

Part 1: 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

Title

Part 1: Maximum Observed Plasma Concentration (Cmax) at Steady State 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

Title

Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax) at Steady State 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

Title

Part 1: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Study Treatment Discontinuation

Description

Time Frame

Up to Week 100

Title

Part 1: Change from Baseline in Height at Weeks 24, 48, 72, 96 and 100

Time Frame

Baseline, Weeks 24, 48, 72, 96 and 100

Title

Part 1: Change from Baseline in Weight at Weeks 24, 48, 72, 96 and 100

Time Frame

Baseline, Weeks 24, 48, 72, 96 and 100

Title

Part 1: Change from Baseline in Tanner Score at Weeks 24, 48, 72, 96 and 100

Description

Time Frame

Baseline, Weeks 24, 48, 72, 96 and 100

Title

Part 1: Number of Participants With Binding and Neutralizing Antibodies to Interferon Beta Type 1a (IFN β-1a) [All Participants]

Description

Time Frame

Up to Week 96

Title

Part 1: Number of Participants With Binding Antibodies to Peginterferon (PEG) [BIIB017-Treated Participants]

Description

Anti-PEG binding antibodies in human serum will be determined using an ELISA.

Time Frame

Up to Week 96

Title

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

Description

Time Frame

Baseline, Weeks 12, 24, 36, 48, 60, 72, 84, 96 and 100

Title

Part 1: Change from Baseline in Blood Pressure at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Title

Part 1: Change from Baseline in Heart Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Title

Part 1: Change from Baseline in Body Temperature at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Title

Part 1: Change from Baseline in Respiratory Rate at Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84,96 and 100

Title

Part 1: Change from Baseline in 12-Lead Electrocardiogram (ECG) Parameters at Weeks 48, 96 and 100

Time Frame

Baseline (Before dosing), Weeks 48, 96 and 100

Title

Part 1: Percentage of Participants with Changes Over Time in Clinical Laboratory Values

Description

Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.

Time Frame

Baseline, Weeks 4, 8, 12, 24, 36, 48, 60, 72, 84, 96 and 100

Title

Part 2: ARR at Weeks 144 and 192

Description

Time Frame

Weeks 144 and 192

Title

Part 2: Change from Baseline in EDSS Score at Weeks 120, 144, 168, 192 and 196

Description

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).

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Change from Baseline in Height at Weeks 120, 144, 168, 192 and 196

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Change from Baseline in Weight at Weeks 120, 144, 168, 192 and 196

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Change from Baseline in Tanner Score at Weeks 120, 144, 168, 192 and 196

Description

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.

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Number of Participants With Binding and Neutralizing Antibodies to IFN β-1a (All Participants)

Description

Presence of IFN β-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.

Time Frame

Up to Week 192

Title

Part 2: Number of Participants With Binding Antibodies to PEG (BIIB017-Treated Participants)

Description

Anti-PEG binding antibodies in human serum will be determined using an ELISA.

Time Frame

Up to Week 192

Title

Part 2: Change from Baseline in Blood Pressure at Weeks 120,144,168,192 and 196

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Change from Baseline in Heart Rate at Weeks 120, 144, 168, 192 and 196

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Change from Baseline in Body Temperature at Weeks 120, 144, 168, 192 and 196

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Change from Baseline in Respiratory Rate at Weeks 120, 144, 168, 192 and 196

Time Frame

Baseline (Week 96), Weeks 120, 144, 168, 192 and 196

Title

Part 2: Change from Baseline in 12-Lead ECG Parameters at Weeks 144, 192 and 196

Time Frame

Baseline (Week 96), Weeks 144, 192 and 196

Title

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

Description

MINI-KID is a structured diagnostic interview instrument for psychiatric evaluation and outcome tracking. All questions are answered Yes or No.

Time Frame

Baseline (Week 96), Weeks 108, 120, 132, 144,156, 168, 180, 192 and 196

Title

Part 2: Percentage of Participants with Changes Over Time in Clinical Laboratory Values

Description

Clinical laboratory tests include: hematology, chemistry (including liver, renal and thyroid function), and coagulation tests.

Time Frame

Baseline (Week 96), Weeks 108, 120, 132, 144, 156, 168, 180, 192 and 196

10. Eligibility

Sex

All

Minimum Age & Unit of Time

10 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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"

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

US Biogen Clinical Trial Center

Phone

866-633-4636

clinicaltrials@biogen.com

First Name & Middle Initial & Last Name or Official Title & Degree

Global Biogen Clinical Trial Center

clinicaltrials@biogen.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Director

Organizational Affiliation

Biogen

Official's Role

Study Director

Facility Information:

Facility Name

UC San Diego Health

City

San Diego

State/Province

California

ZIP/Postal Code

92121

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

8582462384

First Name & Middle Initial & Last Name & Degree

Jennifer Sharon Graves

Facility Name

UNC Hospitals

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27514

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

919-945-4752

First Name & Middle Initial & Last Name & Degree

Irena Dujmovic Basuroski

Facility Name

Meridian Clinical Research

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

Country

United States

Individual Site Status

Completed

Facility Name

Hospital Italiano de Buenos Aires

City

Ciudad Autonoma de Buenos Aires

State/Province

Buenos Aires

ZIP/Postal Code

C1181ACH

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

Phone

541121131241

First Name & Middle Initial & Last Name & Degree

Clarisa Maxit

Facility Name

Royal Children's Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Individual Site Status

Recruiting

Facility Name

Universitair Ziekenhuis Gent

City

Gent

State/Province

East Flanders

ZIP/Postal Code

9000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

Phone

3293323597

First Name & Middle Initial & Last Name & Degree

Helene Verhelst

Facility Name

Clinique CHC MontLégia

City

Liege

State/Province

Wallonia

ZIP/Postal Code

4000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

Phone

3242248911

First Name & Middle Initial & Last Name & Degree

Annick Melin

Facility Name

MHATNP "Sv.Naum", EAD

City

Sofia

ZIP/Postal Code

1113

Country

Bulgaria

Individual Site Status

Recruiting

Facility Contact:

Phone

35929702100

First Name & Middle Initial & Last Name & Degree

Veneta Bojinova-Tchamova

Facility Name

University Hospital Centre Split

City

Split

State/Province

Dalmatia

ZIP/Postal Code

21000

Country

Croatia

Individual Site Status

Recruiting

Facility Contact:

Phone

38521556288

First Name & Middle Initial & Last Name & Degree

Eugenija Marusic

Facility Name

Children's Hospital Zagreb

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Individual Site Status

Recruiting

Facility Contact:

Phone

38514600138

First Name & Middle Initial & Last Name & Degree

Vlasta Djuranovic

Facility Name

Clinical Hospital 'Sestre Milosrdnice'

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Individual Site Status

Recruiting

Facility Contact:

Phone

38513787111

First Name & Middle Initial & Last Name & Degree

Masa Malenica

Facility Name

University Hospital Centre Zagreb

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Individual Site Status

Recruiting

Facility Contact:

Phone

38512388310

First Name & Middle Initial & Last Name & Degree

Mario Habek

Facility Name

Fakultni nemocnice Hradec Kralove

City

Hradec Kralove

ZIP/Postal Code

50333

Country

Czechia

Individual Site Status

Recruiting

Facility Contact:

Phone

420495835214

First Name & Middle Initial & Last Name & Degree

Martin Valis

Facility Name

CHU Strasbourg - Hôpital Hautepierre

City

Strasbourg

State/Province

Bas Rhin

ZIP/Postal Code

67098

Country

France

Individual Site Status

Recruiting

Facility Contact:

Phone

33388128544

First Name & Middle Initial & Last Name & Degree

Jerome De Seze

Facility Name

Hopital Purpan

City

Toulouse cedex 9

State/Province

Haute Garonne

ZIP/Postal Code

31059

Country

France

Individual Site Status

Recruiting

Facility Contact:

Phone

33534557408

First Name & Middle Initial & Last Name & Degree

Emmanuel Cheuret

Facility Name

Hopital Gui de Chauliac

City

Montpellier

State/Province

Herault

ZIP/Postal Code

34295

Country

France

Individual Site Status

Recruiting

Facility Contact:

Phone

33467337422

First Name & Middle Initial & Last Name & Degree

Pierre Meyer

Facility Name

Hopital Roger Salengro - CHU Lille

City

Lille

State/Province

Nord

ZIP/Postal Code

59037

Country

France

Individual Site Status

Recruiting

Facility Contact:

Phone

33320445962

First Name & Middle Initial & Last Name & Degree

Helene Zephir

Facility Name

Hôpital Bicêtre

City

Le Kremlin Bicêtre cedex

State/Province

Val De Marne

ZIP/Postal Code

94275

Country

France

Individual Site Status

Recruiting

Facility Contact:

Phone

33145213112

First Name & Middle Initial & Last Name & Degree

Kumaran Deiva

Facility Name

Universitaetsklinikum Freiburg

City

Freiburg

State/Province

Baden Wuerttemberg

ZIP/Postal Code

79106

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

Phone

4976127045900

First Name & Middle Initial & Last Name & Degree

Matthias Eckenweiler

Facility Name

Universitaetsmedizin Goettingen

City

Gottingen

State/Province

Niedersachsen

ZIP/Postal Code

37075

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

Phone

49551398035

First Name & Middle Initial & Last Name & Degree

Jutta Gaertner

Facility Name

St. Josef-Hospital Universitaetsklinikum

City

Bochum

State/Province

Nordrhein Westfalen

ZIP/Postal Code

44791

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

Phone

492345092687

First Name & Middle Initial & Last Name & Degree

Thomas Luecke

Facility Name

Charité - Campus Virchow-Klinikum

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

Phone

4930450566112

First Name & Middle Initial & Last Name & Degree

Angela Kaindl

Facility Name

General Hospital of Larissa

City

Larissa

State/Province

Thessaly

ZIP/Postal Code

41110

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

Phone

3021413502745

First Name & Middle Initial & Last Name & Degree

Efthymios Dardiotis

Facility Name

IASO Children's Hospital

City

Marousi

ZIP/Postal Code

15123

Country

Greece

Individual Site Status

Withdrawn

Facility Name

General Hospital of Thessaloniki 'Hippokration'

City

Thessaloniki

ZIP/Postal Code

54642

Country

Greece

Individual Site Status

Recruiting

Facility Contact:

Phone

302313312437

First Name & Middle Initial & Last Name & Degree

Dimitrios Zafeiriou

Facility Name

Pecsi Tudomanyegyetem

City

Pecs

State/Province

Baranya

ZIP/Postal Code

7623

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

Phone

3672535900

First Name & Middle Initial & Last Name & Degree

Katalin Dr. Ohmachtne Hollody

Facility Name

Debreceni Egyetem

City

Debrecen

State/Province

Hajdú-Bihar

ZIP/Postal Code

4032

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

Phone

36709450368

First Name & Middle Initial & Last Name & Degree

Monika Bessenyei

Facility Name

Semmelweis Egyetem AOK

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Individual Site Status

Recruiting

Facility Contact:

Phone

+3614591500

Ext

52695

First Name & Middle Initial & Last Name & Degree

Viktor Farkas

Facility Name

Hadassah University Hospital - Ein Kerem

City

Jerusalem

State/Province

Levant

ZIP/Postal Code

9112001

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

Phone

97226776936

First Name & Middle Initial & Last Name & Degree

Adi Vaknin-Dembinsky

Facility Name

Schneider Children's Medical Center

City

Petach-Tikva

State/Province

Tel Aviv

ZIP/Postal Code

4920235

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

Phone

97239253875

First Name & Middle Initial & Last Name & Degree

Esther Ganelin-Cohen

Facility Name

Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"

City

Napoli

State/Province

Campania

ZIP/Postal Code

80138

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

Phone

39815666788

First Name & Middle Initial & Last Name & Degree

Giacomo Lus

Facility Name

Azienda Ospedaliero Universitaria Ospedale Pediatrico Meyer

City

Firenze

ZIP/Postal Code

50139

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

Phone

39555662705

First Name & Middle Initial & Last Name & Degree

Federico Melani

Facility Name

Azienda Ospedaliera Universitaria 'Federico II'

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Individual Site Status

Recruiting

Facility Contact:

Phone

39817462670

First Name & Middle Initial & Last Name & Degree

Vincenzo Brescia Morra

Facility Name

Ibn Sina Hospital

City

Shuwaikh

ZIP/Postal Code

12345

Country

Kuwait

Individual Site Status

Recruiting

Facility Contact:

Phone

96599304949

First Name & Middle Initial & Last Name & Degree

Raed Al Roughani

Facility Name

Centro Hospitalar e Universitário Lisboa Norte E.P.E.

City

Lisboa

State/Province

Lisbon

ZIP/Postal Code

1649-035

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

Phone

351912263284

First Name & Middle Initial & Last Name & Degree

Joao De Sa

Facility Name

Hospital Beatriz Ângelo

City

Loures

State/Province

Lisbon

ZIP/Postal Code

2674-514

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

Phone

351214348200

First Name & Middle Initial & Last Name & Degree

Ângela Timoteo

Facility Name

Hospital de Braga

City

Braga

State/Province

Minho

ZIP/Postal Code

4710-243

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

Phone

351915301556

First Name & Middle Initial & Last Name & Degree

Joao Jose Cerqueira

Facility Name

Centro Hospitalar e Universitário de Coimbra E.P.E. - Hospital Pediátrico

City

Coimbra

ZIP/Postal Code

3000-602

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

Phone

351239800052

First Name & Middle Initial & Last Name & Degree

Filipe Palavra

Facility Name

Centro Hospitalar do Porto, E.P.E. - Hospital de Santo António

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Individual Site Status

Recruiting

Facility Contact:

Phone

351222077500

First Name & Middle Initial & Last Name & Degree

Sonia Figueiroa

Facility Name

SBEI HPE 'Bashkir State Medical University' of the MoH of the RF

City

Ufa

State/Province

Bashkortostan

ZIP/Postal Code

450077

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

FSBI "Federal Siberian Scientific-Clinical Center of FMBA"

City

Krasnoyarsk

State/Province

Krasnoyarsk Krai

ZIP/Postal Code

660037

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

LLC National center for socially significan disease

City

St. Petersburg

State/Province

Leningrad

ZIP/Postal Code

197110

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

Nebbiolo LLC

City

Tomsk

State/Province

Oblast

ZIP/Postal Code

634009

Country

Russian Federation

Individual Site Status

Completed

Facility Name

SAIH 'Kemerovo Regional Clinical Hospital'

City

Kemerovo

State/Province

Siberia

ZIP/Postal Code

650066

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

RSBIH 'Belgorod Regional Clinical Hospital of Saint Ioasaf'

City

Belgorod

ZIP/Postal Code

308007

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

SBHI

City

Moscow

ZIP/Postal Code

119602

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

SBIH of Moscow region "Moscow Regional Scientific & Research

City

Moscow

ZIP/Postal Code

129110

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

SBEI HPE 'Rostov State Medical University' of the MoH of the RF

City

Rostov-on-Don

ZIP/Postal Code

344022

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

State Budgetary Institution of Healthcare of Yaroslavl region 'Clinical Hospital # 2'

City

Yaroslavl

ZIP/Postal Code

150000

Country

Russian Federation

Individual Site Status

Active, not recruiting

Facility Name

King Faisal Specialist Hospital & Research Center

City

Jeddah

State/Province

Makkah

ZIP/Postal Code

40047

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

Phone

966555996542

First Name & Middle Initial & Last Name & Degree

Ebtesam S. Alshehri

Facility Name

King Saud University

City

Riyadh

ZIP/Postal Code

11472

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact:

Phone

966504483865

First Name & Middle Initial & Last Name & Degree

Nuha Al Khawajah

Facility Name

Clinic of Neurology and Psychiatry for Children and Youth

City

Belgrade

State/Province

Balkans

ZIP/Postal Code

11000

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

Phone

381112658355

First Name & Middle Initial & Last Name & Degree

Jasna Jancic

Facility Name

University Children's Hospital

City

Belgrade

State/Province

Balkans

ZIP/Postal Code

11000

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

Phone

38163404063

First Name & Middle Initial & Last Name & Degree

Dimitrije Nikolic

Facility Name

Mother and Child Health Care Institute of Serbia ''Dr Vukan Cupic''

City

Belgrade

State/Province

Balkans

ZIP/Postal Code

11070

Country

Serbia

Individual Site Status

Recruiting

Facility Contact:

Phone

381113108144

First Name & Middle Initial & Last Name & Degree

Slavica Ostojic

Facility Name

Narodny ustav detskych chorob

City

Bratislava

ZIP/Postal Code

83340

Country

Slovakia

Individual Site Status

Recruiting

Facility Contact:

Phone

421259371100

First Name & Middle Initial & Last Name & Degree

Miriam Kolnikova

Facility Name

Hospital Sant Joan de Deu

City

Esplugues de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08950

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

Phone

34932271738

First Name & Middle Initial & Last Name & Degree

Thais Armangue Salvador

Facility Name

Hospital Universitario Virgen de la Arrixaca

City

El Palmar

State/Province

Murcia

ZIP/Postal Code

30120

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

Phone

34968369534

First Name & Middle Initial & Last Name & Degree

Jose Eustasio Meca Lallana

Facility Name

Hospital Universitario Reina Sofia

City

Cordoba

ZIP/Postal Code

14004

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

Phone

34957012580

First Name & Middle Initial & Last Name & Degree

Eduardo Aguera Morales

Facility Name

Hospital Universitario Ramon y Cajal

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

Phone

34665249028

First Name & Middle Initial & Last Name & Degree

Lucienne Costa-Frossard Franca

Facility Name

Hopital Razi

City

Manouba

State/Province

Mannouba

ZIP/Postal Code

2010

Country

Tunisia

Individual Site Status

Recruiting

Facility Contact:

Phone

21671600339

First Name & Middle Initial & Last Name & Degree

Riadh Gouider

Facility Name

Hôpital Fattouma Bourghiba

City

Monastir

ZIP/Postal Code

5000

Country

Tunisia

Individual Site Status

Recruiting

Facility Contact:

Phone

21673106035

First Name & Middle Initial & Last Name & Degree

Mahbouba Frih

Facility Name

Hôpital Habib Bourguiba

City

Sfax

ZIP/Postal Code

3029

Country

Tunisia

Individual Site Status

Recruiting

Facility Contact:

Phone

21674106047

First Name & Middle Initial & Last Name & Degree

Chokri Mhiri

Facility Name

Gazi University Medical Faculty Clinical Research Unit

City

Ankara

ZIP/Postal Code

06500

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

Phone

+90 532 325 19 83

First Name & Middle Initial & Last Name & Degree

Ercan Demir

Facility Name

Akdeniz University Medical Faculty

City

Antalya

ZIP/Postal Code

07059

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

Phone

905327243824

First Name & Middle Initial & Last Name & Degree

Ozgur Duman

Facility Name

Izmir Dr. Behcet Uz Cocuk Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi

City

Izmir

ZIP/Postal Code

35210

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

Phone

905327163537

First Name & Middle Initial & Last Name & Degree

Unsal Yilmaz

Facility Name

Ondokuz Mayis Univ. Med. Fac.

City

Samsun

ZIP/Postal Code

55139

Country

Turkey

Individual Site Status

Recruiting

Facility Contact:

Phone

903623121919

First Name & Middle Initial & Last Name & Degree

Murat Terzi

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

IPD Sharing URL

https://vivli.org/

Learn more about this 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

We'll reach out to this number within 24 hrs