Trial Outcomes & Findings for Long-Term Safety and Efficacy Study of Peginterferon Beta-1a (NCT NCT01332019)

NCT ID: NCT01332019

Last Updated: 2017-01-13

Results Overview

AE: any untoward medical occurrence that did not necessarily have a causal relationship with study treatment. SAE: any untoward medical occurrence that at any dose: resulted in death; in the view of the Investigator, placed the participant at immediate risk of death (a life threatening event); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect; any other medically important event that, in the opinion of the Investigator, could have jeopardized the participant or may have required intervention to prevent one of the other outcomes listed in the definition above. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1077 participants

Primary outcome timeframe

up to 4 years

Results posted on

2017-01-13

Participant Flow

Study 105MS302 (NCT01332019) is an extension study and includes participants previously randomized to Study 105MS301 (NCT00906399). Only participants in Study 105MS301 who completed the study treatment and visit schedule through Week 96 were eligible for entry into this study.

Participants continued BIIB017 at the same dosage regimen they were following during treatment year 2 of Study 105MS301: BIIB017 125 μg subcutaneously (SC) every 2 weeks (Q2W) or every 4 weeks (Q4W). A major change in study design was introduced in Amendment 3 of the protocol, which switched all ongoing subjects dosing Q4W to dosing Q2W.

Participant milestones

Participant milestones
Measure	BIIB017 Q4W 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Overall Study STARTED	530	547
Overall Study COMPLETED	417	425
Overall Study NOT COMPLETED	113	122

Reasons for withdrawal

Reasons for withdrawal
Measure	BIIB017 Q4W 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Overall Study Was Not Dosed	1	0
Overall Study Other	16	18
Overall Study Death	2	1
Overall Study Physician Decision	4	3
Overall Study Withdrawal by Subject	73	71
Overall Study Lost to Follow-up	4	7
Overall Study Adverse Event	13	22

Baseline Characteristics

Long-Term Safety and Efficacy Study of Peginterferon Beta-1a

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.	Total n=1076 Participants Total of all reporting groups
Age, Continuous	38.1 years STANDARD_DEVIATION 9.95 • n=5 Participants	38.7 years STANDARD_DEVIATION 9.59 • n=7 Participants	38.4 years STANDARD_DEVIATION 9.77 • n=5 Participants
Age, Customized 20-29 years	131 participants n=5 Participants	107 participants n=7 Participants	238 participants n=5 Participants
Age, Customized 30-39 years	165 participants n=5 Participants	180 participants n=7 Participants	345 participants n=5 Participants
Age, Customized 40-49 years	150 participants n=5 Participants	172 participants n=7 Participants	322 participants n=5 Participants
Age, Customized 50-59 years	80 participants n=5 Participants	83 participants n=7 Participants	163 participants n=5 Participants
Age, Customized 60-65 years	3 participants n=5 Participants	5 participants n=7 Participants	8 participants n=5 Participants
Gender Female	378 Participants n=5 Participants	397 Participants n=7 Participants	775 Participants n=5 Participants
Gender Male	151 Participants n=5 Participants	150 Participants n=7 Participants	301 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to 4 years

Population: Safety population: all participants who received at least 1 dose of study drug. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs Any event	471 participants	478 participants
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs Moderate or severe event	343 participants	348 participants
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs Severe event	74 participants	73 participants
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs Discontinuing study treatment due to an event	18 participants	26 participants
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs Withdrawing from study due to an event	14 participants	23 participants
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs Event related to study treatment	400 participants	399 participants
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs Serious event	113 participants	90 participants

PRIMARY outcome

Timeframe: up to 4 years

Population: Safety population: all participants who received at least 1 dose of study drug and at least 1 post-baseline value for given parameter.

Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=528 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities White blood cells < 3.0*10^9/L	28 participants	86 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Lymphocytes < 0.5*10^9/L	2 participants	7 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Lymphocytes > 12*10^9/L	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Segmented neutrophils ≤ 1*10^9/L	8 participants	16 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Segmented neutrophils < 1.5*10^9/L	31 participants	84 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Segmented neutrophils ≥ 12*10^9/L	18 participants	5 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Total absolute neutrophils ≤ 1*10^9/L	8 participants	15 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities White blood cells ≥ 16.0*10^9/L	13 participants	4 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Lymphocytes < 0.8*10^9/L	41 participants	62 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Total absolute neutrophils < 1.5*10^9/L	31 participants	83 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Total absolute neutrophils ≥ 12*10^9/L	18 participants	5 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Red blood cells ≤ 3.3*10^12/L	1 participants	7 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Red blood cells ≥ 6.8*10^12/L	0 participants	0 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Hemoglobin ≤ 100 g/L	33 participants	35 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Platelet count ≤ 100*10^9/L	3 participants	11 participants
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities Platelet count ≥ 600*10^9/L	2 participants	2 participants

PRIMARY outcome

Timeframe: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

Population: Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low (or high) and who had at least 1 post-baseline value.

Shift to low includes normal to low, high to low, and unknown to low. Shift to high includes normal to high, low to high, and unknown to high. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. ALT=alanine aminotransferase; AST=aspartate aminotransferase; GGT=gamma-glutamyl transferase.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values ALT: shift to low; n=528, 546	3 participants	3 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values ALT: shift to high; n=487, 497	119 participants	153 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values Total bilirubin: shift to low; n=512, 517	94 participants	76 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values Alkaline phosphatase: shift to low; n=522, 543	4 participants	5 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values Alkaline phosphatase: shift to high; n=516, 536	28 participants	26 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values Lactate dehydrogenase: shift to low; n=529, 547	0 participants	0 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values Lactate dehydrogenase: shift to high; n=524, 541	18 participants	30 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values AST: shift to low; n=528, 546	10 participants	8 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values AST: shift to high; n=514, 530	75 participants	110 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values Total bilirubin: shift to high; n=511, 535	22 participants	16 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values GGT: shift to low; n=529, 545	16 participants	6 participants
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values GGT: shift to high; n=512, 528	73 participants	97 participants

PRIMARY outcome

Timeframe: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Blood urea nitrogen: shift to low; n=529, 546	0 participants	1 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Creatinine: shift to low; n=529, 547	0 participants	1 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Sodium: shift to high; n=524, 544	39 participants	46 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Potassium: shift to low; n=527, 544	13 participants	21 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Potassium: shift to high; n=528, 546	17 participants	20 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry TSH: shift to high; n=518, 539	37 participants	55 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Chloride: shift to high; n=528, 547	0 participants	3 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Glucose: shift to low; n=522, 539	54 participants	51 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Glucose: shift to high; n=506, 513	304 participants	311 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry TSH: shift to low; n=515, 533	47 participants	30 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Blood urea nitrogen: shift to high; n=527, 543	16 participants	20 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Creatinine: shift to high; n=528, 545	15 participants	8 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Bicarbonate: shift to low; n=523, 540	49 participants	64 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Bicarbonate: shift to high; n=529, 544	0 participants	0 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Sodium: shift to low; n=529, 546	0 participants	3 participants
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry Chloride: shift to low; n=529, 546	1 participants	2 participants

PRIMARY outcome

Timeframe: Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years

Population: Safety population: all participants who received at least 1 dose of study drug; n=number of participants whose baseline value was not low or high/positive and who had at least 1 post-baseline value.

Shift to low includes normal to low, high to low, and unknown to low. Shift to high/positive includes normal to high/positive, low to high/positive, negative to high/positive, and unknown to high/positive. For participants who switched to alternative MS medications, data after switch and 14 days after last dose of study treatment are excluded. Data collected after Amendment 3 took effect were excluded for participants enrolled into study 105MS302 on every 4 week dosing, but not excluded for participants enrolled on every 2 week dosing. Pos=positive; RBC=red blood cells; WBC=white blood cells.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of Participants With Shifts From Baseline: Urinalysis Specific gravity: shift to low; n=525, 545	2 participants	1 participants
Number of Participants With Shifts From Baseline: Urinalysis Specific gravity: shift to high/pos; n=528,547	13 participants	3 participants
Number of Participants With Shifts From Baseline: Urinalysis pH: shift to high/pos; n=528, 547	6 participants	4 participants
Number of Participants With Shifts From Baseline: Urinalysis Glucose: shift to high/pos; n=521, 542	28 participants	25 participants
Number of Participants With Shifts From Baseline: Urinalysis WBC: shift to high/pos; n=472, 495	116 participants	130 participants
Number of Participants With Shifts From Baseline: Urinalysis Bilirubin: shift to high/pos; n=529, 547	0 participants	1 participants
Number of Participants With Shifts From Baseline: Urinalysis Urobilinogen: shift to high/pos; n=529, 546	7 participants	13 participants
Number of Participants With Shifts From Baseline: Urinalysis pH: shift to low; n=529, 547	0 participants	0 participants
Number of Participants With Shifts From Baseline: Urinalysis Color: shift to high/pos; n=516, 529	33 participants	36 participants
Number of Participants With Shifts From Baseline: Urinalysis Blood: shift to high/pos; n=469, 495	159 participants	167 participants
Number of Participants With Shifts From Baseline: Urinalysis Ketones: shift to high/pos; n=510, 530	64 participants	73 participants
Number of Participants With Shifts From Baseline: Urinalysis Protein: shift to high/pos; n=380, 391	270 participants	277 participants
Number of Participants With Shifts From Baseline: Urinalysis RBC: shift to high/pos; n=419, 402	110 participants	106 participants
Number of Participants With Shifts From Baseline: Urinalysis Nitrite: shift to high/pos; n=508, 519	84 participants	94 participants

SECONDARY outcome

Timeframe: up to 4 years

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.

Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. The annualized relapse rate is calculated as the total number of relapses occurred during the period for all participants, divided by the total number of person-years followed in the period.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=232 Relapses 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=200 Relapses 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Annualized Relapse Rate (ARR)	0.189 relapses per person-years Interval 0.154 to 0.231	0.142 relapses per person-years Interval 0.114 to 0.177

SECONDARY outcome

Timeframe: Up to 4 years

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.

Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. New or recurrent neurologic symptoms that occur less than 30 days following the onset of a relapse were considered part of the same relapse. Participants who did not experience a relapse prior to switching to alternative MS medications, withdrew from study, or Amendment 3 (A3) took effect were censored at the time of switch/withdrawal/A3 effective date.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Percentage of Participants Who Relapsed Did not relapse	71 percentage of participants	77 percentage of participants
Percentage of Participants Who Relapsed Relapsed	29 percentage of participants	23 percentage of participants

SECONDARY outcome

Timeframe: Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

The total number of new or newly enlarging T2 hyperintense lesions (from Study 105MS302 Baseline) as assessed by magnetic resonance imaging (MRI). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=481 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=493 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of New or Newly Enlarging T2 Hyperintense Lesions Week 96; n=411, 407	8.9 lesions Standard Deviation 16.64	3.9 lesions Standard Deviation 9.37
Number of New or Newly Enlarging T2 Hyperintense Lesions Week 48; n=481, 493	4.4 lesions Standard Deviation 8.19	1.9 lesions Standard Deviation 4.50

SECONDARY outcome

Timeframe: Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

The number of new active lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of New Active Lesions Week 48; n=481, 493	4.4 lesions Standard Deviation 8.25	2.0 lesions Standard Deviation 4.62
Number of New Active Lesions Week 96; n=411, 406	9.0 lesions Standard Deviation 16.88	3.9 lesions Standard Deviation 9.47

SECONDARY outcome

Timeframe: Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

The total number of new T1 hypointense lesions as assessed by MRI.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of New T1 Hypointense Lesions Week 49; n=481, 493	1.4 lesions Standard Deviation 3.02	0.8 lesions Standard Deviation 2.18
Number of New T1 Hypointense Lesions Week 96; n=411, 406	2.8 lesions Standard Deviation 5.92	1.5 lesions Standard Deviation 4.14

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

The number of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of Gd-Enhancing Lesions Week 48; n=481, 493	0.7 lesions Standard Deviation 2.07	0.2 lesions Standard Deviation 1.42
Number of Gd-Enhancing Lesions Week 96; n=411, 407	0.8 lesions Standard Deviation 2.59	0.2 lesions Standard Deviation 0.89
Number of Gd-Enhancing Lesions Baseline; n=528, 543	0.6 lesions Standard Deviation 1.85	0.2 lesions Standard Deviation 1.07

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

The volume of T2 hyperintense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Volume of T2 Hyperintense Lesions Baseline; n=528, 543	11.4742 cm^3 Standard Deviation 13.55811	9.9678 cm^3 Standard Deviation 11.41807
Volume of T2 Hyperintense Lesions Week 48; n=481, 493	11.7421 cm^3 Standard Deviation 13.91774	9.8335 cm^3 Standard Deviation 11.05029
Volume of T2 Hyperintense Lesions Week 96; n=411, 407	12.0257 cm^3 Standard Deviation 13.91056	9.9487 cm^3 Standard Deviation 10.97208

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

The volume of T1 hypointense lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Volume of T1 Hypointense Lesions Baseline; n=528, 543	3.9869 cm^3 Standard Deviation 6.29557	3.6320 cm^3 Standard Deviation 5.47465
Volume of T1 Hypointense Lesions Week 48; n=481, 493	4.3062 cm^3 Standard Deviation 6.92839	3.6529 cm^3 Standard Deviation 5.19027
Volume of T1 Hypointense Lesions Week 96; n=411, 407	4.3171 cm^3 Standard Deviation 6.70107	3.7494 cm^3 Standard Deviation 5.21314

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

The volume of Gd-enhancing lesions as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Volume of Gd-Enhancing Lesions Baseline; n=528, 543	0.0911 cm^3 Standard Deviation 0.30013	0.0348 cm^3 Standard Deviation 0.17344
Volume of Gd-Enhancing Lesions Week 48; n=481, 493	0.1172 cm^3 Standard Deviation 0.42762	0.0477 cm^3 Standard Deviation 0.31479
Volume of Gd-Enhancing Lesions Week 96; n=411, 407	0.1346 cm^3 Standard Deviation 0.50580	0.0357 cm^3 Standard Deviation 0.14976

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Week 48, Week 96

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

Percentage change of whole brain volume as assessed by MRI. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Percentage Change of Whole Brain Volume Change at Week 48; n=402, 418	-0.522 percentage change Standard Deviation 0.6205	-0.453 percentage change Standard Deviation 0.8127
Percentage Change of Whole Brain Volume Change at Week 96; n=365, 358	-0.835 percentage change Standard Deviation 1.0785	-0.788 percentage change Standard Deviation 1.1912

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=number of participants with an assessment at given timepoint.

Change from Baseline in disability as measured by the Expanded Disability Status Scale (EDSS). The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 24; n=500, 519	0.02 units on a scale Standard Deviation 0.449	0.00 units on a scale Standard Deviation 0.486
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 48; n=488, 497	0.08 units on a scale Standard Deviation 0.564	0.03 units on a scale Standard Deviation 0.510
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 72; n=468, 484	0.13 units on a scale Standard Deviation 0.629	0.06 units on a scale Standard Deviation 0.484
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 96; n=429, 446	0.15 units on a scale Standard Deviation 0.618	0.09 units on a scale Standard Deviation 0.563
Change From Baseline in Expanded Disability Status Scale (EDSS) Baseline; n=516, 535	2.43 units on a scale Standard Deviation 1.346	2.35 units on a scale Standard Deviation 1.299
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 12; n=503, 524	0.02 units on a scale Standard Deviation 0.388	0.00 units on a scale Standard Deviation 0.450
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 120; n=187, 205	0.19 units on a scale Standard Deviation 0.700	0.10 units on a scale Standard Deviation 0.538
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 144; n=90, 98	0.23 units on a scale Standard Deviation 0.720	0.10 units on a scale Standard Deviation 0.587
Change From Baseline in Expanded Disability Status Scale (EDSS) Change at Week 168; n=21, 25	0.24 units on a scale Standard Deviation 0.889	0.18 units on a scale Standard Deviation 0.454

SECONDARY outcome

Timeframe: Weeks 12, 24, 28, 72, 96, 120, 144, 168

Population: Participants in the ITT population (all participants who were assigned a treatment and received at least 1 dose of study treatment) with disability progression.

Estimated proportion of participants with progression and time to progression based on the Kaplan-Meier product limit method. Sustained disability progression is defined as: at least a 1.0 point increase on the EDSS from 105MS302 baseline EDSS ≥ 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from 105MS302 baseline EDSS = 0 that is sustained for 24 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10. The range of main categories include (0) = normal neurologic exam; to (5) = ambulatory without aid or rest for 200 meters; disability severe enough to impair full daily activities; to (10) = death due to MS. Participants were censored at the time of withdrawal/switch/A3 effective date if they withdrew from study, switched to alternative MS medication, or Amendment 3 took effect without a progression.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=63 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=38 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Time to Sustained Disability Progression Progressed at 120 weeks	0.147 proportion of participants	0.085 proportion of participants
Time to Sustained Disability Progression Progressed at 144 weeks	0.161 proportion of participants	0.096 proportion of participants
Time to Sustained Disability Progression Progressed at 12 weeks	0.023 proportion of participants	0.007 proportion of participants
Time to Sustained Disability Progression Progressed at 24 weeks	0.046 proportion of participants	0.023 proportion of participants
Time to Sustained Disability Progression Progressed at 48 weeks	0.079 proportion of participants	0.045 proportion of participants
Time to Sustained Disability Progression Progressed at 72 weeks	0.103 proportion of participants	0.057 proportion of participants
Time to Sustained Disability Progression Progressed at 96 weeks	0.115 proportion of participants	0.069 proportion of participants
Time to Sustained Disability Progression Progressed at 168 weeks	NA proportion of participants Estimated proportion is not calculated if the number of participants at risk is less than 30.	NA proportion of participants Estimated proportion is not calculated if the number of participants at risk is less than 30.

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

SDMT is a screening test for cognitive impairment. Participants are given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 (worst) to 110 (best).

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Change From Baseline in Symbol Digit Modalities Test (SDMT) Baseline; n=523, 543	52.134 units on a scale Standard Deviation 17.7653	52.744 units on a scale Standard Deviation 17.6994
Change From Baseline in Symbol Digit Modalities Test (SDMT) Change at Week 24; n=508, 530	-0.313 units on a scale Standard Deviation 8.5862	-1.106 units on a scale Standard Deviation 8.1292
Change From Baseline in Symbol Digit Modalities Test (SDMT) Change at Week 48; n=493, 509	-0.365 units on a scale Standard Deviation 9.3557	-0.864 units on a scale Standard Deviation 8.6059
Change From Baseline in Symbol Digit Modalities Test (SDMT) Change at Week 72; n=472, 489	-0.625 units on a scale Standard Deviation 8.8037	-1.012 units on a scale Standard Deviation 8.5038
Change From Baseline in Symbol Digit Modalities Test (SDMT) Change at Week 96; n=435, 450	-0.340 units on a scale Standard Deviation 8.7817	-0.231 units on a scale Standard Deviation 9.3148
Change From Baseline in Symbol Digit Modalities Test (SDMT) Change at Week 120; n=190, 203	-1.305 units on a scale Standard Deviation 8.9248	-1.099 units on a scale Standard Deviation 9.5425
Change From Baseline in Symbol Digit Modalities Test (SDMT) Change at Week 144; n=88, 96	-1.727 units on a scale Standard Deviation 7.7900	-0.906 units on a scale Standard Deviation 10.8367
Change From Baseline in Symbol Digit Modalities Test (SDMT) Change at Week 168; n=21, 25	-4.000 units on a scale Standard Deviation 10.4403	-3.840 units on a scale Standard Deviation 13.4712

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

The 29-item MSIS-29 is a disease-specific participant-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures 20 physical items and 9 psychological items. Responses use a 5-point Likert scale ranging from 1 to 5. All questions are to be answered. The physical well being assessment portion of the MSIS-29 consists of 20 questions in which participants rate the impact of MS on their day-to-day life during the past two weeks from 1=no impact to 5=extreme impact for a total score of 20-100. A lower total score indicates less physically-related impact while a higher total score indicates greater physically-related impact on a participant's functioning. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Change at Week 120; n=193, 205	2.654 units on a scale Standard Deviation 14.2983	0.116 units on a scale Standard Deviation 10.4382
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Change at Week 168; n=20, 26	2.250 units on a scale Standard Deviation 7.3292	-0.288 units on a scale Standard Deviation 13.5615
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Baseline; n=527, 544	20.494 units on a scale Standard Deviation 19.8290	20.218 units on a scale Standard Deviation 19.0264
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Change at Week 24; n=513, 534	-0.152 units on a scale Standard Deviation 9.3332	0.552 units on a scale Standard Deviation 10.0147
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Change at Week 48; n=498, 510	0.462 units on a scale Standard Deviation 10.7054	0.545 units on a scale Standard Deviation 10.6342
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Change at Week 72; n=474, 491	0.937 units on a scale Standard Deviation 11.5682	0.684 units on a scale Standard Deviation 12.4690
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Change at Week 96; n=437, 452	1.471 units on a scale Standard Deviation 10.8997	1.190 units on a scale Standard Deviation 11.4005
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score Change at Week 144; n=88, 98	0.327 units on a scale Standard Deviation 10.5888	0.051 units on a scale Standard Deviation 12.1417

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. MCS computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Change at Week 72; n=474, 491	0.242 units on a scale Standard Deviation 9.3223	-0.162 units on a scale Standard Deviation 9.0676
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Change at Week 96; n=437, 452	-0.141 units on a scale Standard Deviation 9.4833	0.014 units on a scale Standard Deviation 8.8856
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Change at Week 120; n=193, 205	-1.223 units on a scale Standard Deviation 10.4664	0.616 units on a scale Standard Deviation 7.5313
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Baseline; n=527, 544	47.803 units on a scale Standard Deviation 10.2111	48.591 units on a scale Standard Deviation 10.3624
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Change at Week 24; n=514, 535	0.396 units on a scale Standard Deviation 7.5967	-0.734 units on a scale Standard Deviation 8.3567
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Change at Week 48; n=498, 510	0.409 units on a scale Standard Deviation 8.4442	-0.690 units on a scale Standard Deviation 8.3903
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Change at Week 144; n=88, 98	0.346 units on a scale Standard Deviation 8.6814	0.110 units on a scale Standard Deviation 8.0301
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) Change at Week 168; n=20, 26	-0.451 units on a scale Standard Deviation 8.8575	0.294 units on a scale Standard Deviation 9.7505

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

The SF-12 is a multipurpose short form survey with 12 questions, all selected from the SF-36 Health Survey. The questions were combined, scored, and weighted to create two scales that provide glimpses into mental and physical functioning and overall health-related-quality of life. PCS was computed using the scores of 12 questions and range from 0 to 100, where a 0 score indicates the lowest level of health and 100 indicates the highest level of health. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Change From Baseline in SF-12 Physical Component Score (PCS) Change at Week 96; n=437, 452	-0.150 units on a scale Standard Deviation 6.6971	-0.138 units on a scale Standard Deviation 6.4453
Change From Baseline in SF-12 Physical Component Score (PCS) Change at Week 120; n=193, 205	-0.118 units on a scale Standard Deviation 7.8826	0.021 units on a scale Standard Deviation 6.1354
Change From Baseline in SF-12 Physical Component Score (PCS) Change at Week 144; n=88, 98	-0.256 units on a scale Standard Deviation 5.7252	0.118 units on a scale Standard Deviation 6.7830
Change From Baseline in SF-12 Physical Component Score (PCS) Baseline; n=527, 544	45.154 units on a scale Standard Deviation 9.4474	44.902 units on a scale Standard Deviation 9.9312
Change From Baseline in SF-12 Physical Component Score (PCS) Change at Week 24; n=514, 535	0.138 units on a scale Standard Deviation 6.0841	0.337 units on a scale Standard Deviation 5.7878
Change From Baseline in SF-12 Physical Component Score (PCS) Change at Week 48; n=498, 510	-0.351 units on a scale Standard Deviation 6.1785	0.214 units on a scale Standard Deviation 5.8377
Change From Baseline in SF-12 Physical Component Score (PCS) Change at Week 72; n=474, 491	-0.270 units on a scale Standard Deviation 6.6319	-0.169 units on a scale Standard Deviation 6.3824
Change From Baseline in SF-12 Physical Component Score (PCS) Change at Week 168; n=20, 26	-1.558 units on a scale Standard Deviation 7.6525	0.152 units on a scale Standard Deviation 7.5206

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

The EQ-5D is a participant-answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores of 1, 2, or 3 are possible responses for each of 5 questions (1=no problems, 2=some problems, 3=severe problems). A scoring formula developed by the EuroQol Group is then used to assign utility values for each participant's Health State Profile. A summary index score (EQ-5D index score) is derived from the 5 questions by conversion with this scoring formula and a table of scores. EQ-5D Summary Index values ranged from -0.6 (worst health state) to 1.00 (perfect health state). Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Baseline; n=527, 544	0.76 units on a scale Standard Deviation 0.230	0.76 units on a scale Standard Deviation 0.230
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Change at Week 24; n=514, 534	0.00 units on a scale Standard Deviation 0.159	0.00 units on a scale Standard Deviation 0.171
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Change at Week 48; n=498, 510	-0.01 units on a scale Standard Deviation 0.159	0.00 units on a scale Standard Deviation 0.171
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Change at Week 72; n=472, 491	-0.01 units on a scale Standard Deviation 0.158	0.00 units on a scale Standard Deviation 0.179
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Change at Week 96; n=436, 452	-0.01 units on a scale Standard Deviation 0.156	-0.01 units on a scale Standard Deviation 0.195
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Change at Week 120; n=193, 205	-0.02 units on a scale Standard Deviation 0.190	0.00 units on a scale Standard Deviation 0.165
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Change at Week 144; n=88, 98	0.00 units on a scale Standard Deviation 0.169	0.01 units on a scale Standard Deviation 0.166
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score Change at Week 168; n=21, 26	0.00 units on a scale Standard Deviation 0.080	0.02 units on a scale Standard Deviation 0.137

SECONDARY outcome

Timeframe: Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

The EQ-5D VAS records the participant's self-rated health on a scale from 0-100 where 100 is the 'best imaginable health state' and 0 is the 'worst imaginable health state.' The scale was normalized to a scale of 0 to 1, with higher values indicating a better health state. Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Change at Week 120; n=193, 204	-0.47 units on a scale Standard Deviation 12.714	-0.88 units on a scale Standard Deviation 12.793
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Change at Week 144; n=88, 97	-0.31 units on a scale Standard Deviation 14.247	-0.87 units on a scale Standard Deviation 14.865
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Baseline; n=527, 542	77.07 units on a scale Standard Deviation 17.623	77.33 units on a scale Standard Deviation 18.348
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Change at Week 24; n=511, 532	-0.22 units on a scale Standard Deviation 11.411	-0.98 units on a scale Standard Deviation 12.064
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Change at Week 48; n=498, 508	-0.81 units on a scale Standard Deviation 12.828	-0.93 units on a scale Standard Deviation 12.719
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Change at Week 72; n=472, 490	-0.59 units on a scale Standard Deviation 12.735	-1.89 units on a scale Standard Deviation 15.270
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Change at Week 96; n=436, 450	-1.10 units on a scale Standard Deviation 14.266	-2.20 units on a scale Standard Deviation 14.095
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) Change at Week 168; n=21, 26	1.38 units on a scale Standard Deviation 14.925	0.46 units on a scale Standard Deviation 12.602

SECONDARY outcome

Timeframe: up to 4 years

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment

Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of Relapses Requiring IV Steroid Use	217 relapses	181 relapses

SECONDARY outcome

Timeframe: up to 4 years

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment

Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Number of MS-Related Hospitalizations	113 hospitalizations	81 hospitalizations

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How tolerable or intolerable do you find the medication?" answers were numerically rated from 1 (extremely intolerable) to 10 (extremely tolerable). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? Year 3; n=82, 88	7.5 units on a scale Standard Deviation 2.46	7.3 units on a scale Standard Deviation 2.17
Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? Year 1; n=482, 496	6.8 units on a scale Standard Deviation 2.36	7.0 units on a scale Standard Deviation 2.21
Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? Year 2; n=425, 430	7.2 units on a scale Standard Deviation 2.28	7.1 units on a scale Standard Deviation 2.27

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How convenient or inconvenient is it to take your medication as instructed?" answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? Year 3; n=82, 88	8.3 units on a scale Standard Deviation 2.05	8.0 units on a scale Standard Deviation 2.08
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? Year 1; n=482, 496	8.2 units on a scale Standard Deviation 2.09	8.0 units on a scale Standard Deviation 2.12
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? Year 2; n=426, 430	8.3 units on a scale Standard Deviation 1.98	8.2 units on a scale Standard Deviation 2.05

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How convenient or inconvenient is it to take your medication every 2 weeks?" answers were numerically rated from 1 (extremely inconvenient) to 10 (extremely convenient). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? Year 1; n=482, 496	8.4 units on a scale Standard Deviation 2.02	8.4 units on a scale Standard Deviation 1.99
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? Year 2; n=426, 430	8.6 units on a scale Standard Deviation 1.93	8.4 units on a scale Standard Deviation 2.06
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? Year 3; n=82, 88	8.6 units on a scale Standard Deviation 2.00	8.5 units on a scale Standard Deviation 1.79

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "Overall, how satisfied or dissatisfied are you with this medication?" answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? Year 2; n=426, 430	8.2 units on a scale Standard Deviation 2.04	8.3 units on a scale Standard Deviation 2.00
Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? Year 3; n=82, 88	8.2 units on a scale Standard Deviation 2.00	8.6 units on a scale Standard Deviation 1.60
Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? Year 1; n=482, 496	7.9 units on a scale Standard Deviation 2.04	8.1 units on a scale Standard Deviation 1.97

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How satisfied or dissatisfied are you with the injection frequency (every 2 weeks)?" answers were numerically rated from 1 (extremely dissatisfied) to 10 (extremely satisfied). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? Year 1; n=482, 496	8.4 units on a scale Standard Deviation 1.92	8.3 units on a scale Standard Deviation 1.98
Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? Year 2; n=426, 430	8.5 units on a scale Standard Deviation 1.89	8.3 units on a scale Standard Deviation 2.07
Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? Year 3; n=82, 88	8.7 units on a scale Standard Deviation 1.99	8.6 units on a scale Standard Deviation 1.59

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "How likely would you be to continue to use this medication?" answers were numerically rated from 1 (extremely unlikely) to 10 (extremely likely). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? Year 1; n=482, 496	8.5 units on a scale Standard Deviation 2.11	8.6 units on a scale Standard Deviation 2.00
Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? Year 2; n=426, 430	8.1 units on a scale Standard Deviation 2.67	8.3 units on a scale Standard Deviation 2.58
Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? Year 3; n=82, 88	8.5 units on a scale Standard Deviation 2.39	8.8 units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS. Year 1; n=482, 496	7.3 units on a scale Standard Deviation 2.52	7.8 units on a scale Standard Deviation 2.21
Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS. Year 2; n=426, 430	7.8 units on a scale Standard Deviation 2.35	7.8 units on a scale Standard Deviation 2.31
Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS. Year 3; n=82, 88	8.0 units on a scale Standard Deviation 2.44	8.3 units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "This medication makes it easy for me to carry out my daily responsibilities (ie, going to work, doing household chores or caring for my family)," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=247 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. Year 1; n=482, 496	7.4 units on a scale Standard Deviation 2.44	7.7 units on a scale Standard Deviation 2.33
Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. Year 2; n=426, 429	7.8 units on a scale Standard Deviation 2.32	7.7 units on a scale Standard Deviation 2.35
Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. Year 3; n=82, 88	7.9 units on a scale Standard Deviation 2.57	8.3 units on a scale Standard Deviation 2.07

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "The twice a month dosing makes it more convenient for me to travel/vacation," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation. Year 1; n=482, 496	8.2 units on a scale Standard Deviation 2.21	8.2 units on a scale Standard Deviation 2.13
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation. Year 2; n=426, 430	8.3 units on a scale Standard Deviation 2.20	8.2 units on a scale Standard Deviation 2.21
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation. Year 3; n=82, 88	8.6 units on a scale Standard Deviation 1.97	8.5 units on a scale Standard Deviation 1.86

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "The twice a month dosing enables me to be more spontaneous and flexible," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. Year 1; n=482, 496	8.1 units on a scale Standard Deviation 2.20	8.2 units on a scale Standard Deviation 2.09
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. Year 2; n=426, 430	8.3 units on a scale Standard Deviation 2.12	8.2 units on a scale Standard Deviation 2.12
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. Year 3; n=82, 88	8.5 units on a scale Standard Deviation 2.17	8.4 units on a scale Standard Deviation 1.93

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "This medication improves my self-confidence and self-reliance," answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. Year 2; n=426, 429	7.9 units on a scale Standard Deviation 2.50	7.9 units on a scale Standard Deviation 2.31
Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. Year 3; n=82, 88	8.1 units on a scale Standard Deviation 2.45	8.4 units on a scale Standard Deviation 1.98
Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. Year 1; n=482, 496	7.5 units on a scale Standard Deviation 2.47	7.7 units on a scale Standard Deviation 2.29

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the statement "I am satisfied with the dosing frequency (2 times per month) of this medication" answers were numerically rated from 1 (strongly disagree) to 10 (strongly agree). Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. Year 1; n=482, 496	8.4 units on a scale Standard Deviation 1.98	8.5 units on a scale Standard Deviation 1.94
Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. Year 2; n=425, 430	8.7 units on a scale Standard Deviation 1.83	8.5 units on a scale Standard Deviation 2.06
Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. Year 3; n=82, 88	8.8 units on a scale Standard Deviation 1.87	8.7 units on a scale Standard Deviation 1.81

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "Over the past 4 weeks, did you miss any of your injections?" answer choices were given as "none missed," "miss 1 injection," or "miss 2 injections." Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 3: 1 missed; n=81, 88	0 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 3: 2 missed; n=81, 88	2 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 1: none missed; n=482, 493	474 participants	487 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 1: 1 missed; n=482, 493	8 participants	4 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 1: 2 missed; n=482, 493	0 participants	2 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 2: none missed; n=426, 429	422 participants	426 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 2: 1 missed; n=426, 429	3 participants	2 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 2: 2 missed; n=426, 429	1 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? Year 3: none missed; n=81, 88	79 participants	86 participants

SECONDARY outcome

Timeframe: Year 1, Year 2, Year 3

Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment; n=participants with an assessment who missed at least 1 injection at given timepoint.

Participants completed a Treatment Satisfaction Questionnaire composed of a range of 14 questions regarding the participant's perception of treatment satisfaction at the end of each year of treatment. For the question "Main reason for missed injections?" answer choices were given as "medication side effects," "injection pain," "forget to take medication," "tired of taking injections," "don't think medication is working," or "other." Data after Amendment 3 took effect are excluded.

Outcome measures

Outcome measures
Measure	BIIB017 Q4W n=529 Participants 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 Participants 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 1: medication side effects; n=8, 6	0 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 1: injection pain; n=8, 6	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 1: forget to take medication; n=8, 6	2 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 1: tired of taking injections; n=8, 6	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 1: don't think medication is working; n=8, 6	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 1: other; n=8, 6	6 participants	4 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 2: tired of taking injections; n=4, 3	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 2: don't think medication is working; n=4, 3	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 2: other; n=4, 3	2 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 3: medication side effects; n=2, 2	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 3: tired of taking injections; n=2, 2	1 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 3: don't think medication is working; n=2, 2	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 3: other; n=2, 2	1 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 2: medication side effects; n=4, 3	1 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 2: injection pain; n=4, 3	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 2: forget to take medication; n=4, 3	1 participants	1 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 3: injection pain; n=2, 2	0 participants	0 participants
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections Year 3: forget to take medication; n=2, 2	0 participants	0 participants

Adverse Events

BIIB017 Q4W

Serious events: 114 serious events

Other events: 435 other events

Deaths: 0 deaths

BIIB017 Q2W

Serious events: 91 serious events

Other events: 438 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Biogen Study Medical Director

Biogen

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Publication restrictions are in place

Restriction type: OTHER

Measure	BIIB017 Q4W n=529 participants at risk 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.	BIIB017 Q2W n=547 participants at risk 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
Gastrointestinal disorders Nausea	4.7% 25/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	6.2% 34/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Asthenia	12.1% 64/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	8.2% 45/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Chills	13.2% 70/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	10.6% 58/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Fatigue	7.6% 40/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	9.5% 52/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Influenza like illness	44.2% 234/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	42.8% 234/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Injection site erythema	42.0% 222/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	41.0% 224/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Injection site pain	7.2% 38/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	6.2% 34/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Injection site pruritus	4.5% 24/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	6.2% 34/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
General disorders Pyrexia	27.8% 147/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	24.1% 132/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Infections and infestations Nasopharyngitis	12.9% 68/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	9.0% 49/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Infections and infestations Upper respiratory tract infection	3.4% 18/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	6.2% 34/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Infections and infestations Urinary tract infection	9.6% 51/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	9.7% 53/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Musculoskeletal and connective tissue disorders Arthralgia	9.3% 49/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	9.5% 52/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Musculoskeletal and connective tissue disorders Back pain	10.0% 53/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	10.4% 57/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Musculoskeletal and connective tissue disorders Myalgia	12.3% 65/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	12.2% 67/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Musculoskeletal and connective tissue disorders Pain in extremity	9.8% 52/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	10.1% 55/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Nervous system disorders Headache	28.7% 152/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	29.4% 161/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Nervous system disorders Hypoaesthesia	5.9% 31/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	5.1% 28/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Nervous system disorders Multiple sclerosis relapse	29.3% 155/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	23.8% 130/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Nervous system disorders Paraesthesia	5.9% 31/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	3.7% 20/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Psychiatric disorders Depression	5.1% 27/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	4.8% 26/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)
Psychiatric disorders Insomnia	5.1% 27/529 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)	3.5% 19/547 • up to 4 years All treatment-emergent events are presented. (An event was considered to be treatment emergent if it had an onset date on or after the date of first study treatment or if it was present prior to start of study treatment and subsequently worsened.)