Relapsing Multiple Sclerosis
Conditions
Keywords
Subcutaneous, Extension, Interferon, MS, PEGylated, Injectable, SC, PEG, peginterferon beta-1a, Relapsing
Brief summary
The primary objective of this study is to evaluate the long-term safety and tolerability of peginterferon beta-1a (BIIB017) in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment. The secondary objective of this study is to describe long-term multiple sclerosis (MS) outcomes in participants originally treated in Study 105MS301 (NCT00906399) who continue peginterferon beta-1a treatment.
Interventions
Administered as specified in the treatment arm
Sponsors
Biogen
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must have completed the study treatment and visit schedule through Week 96 in Study 105MS301 (NCT00906399). Key
Exclusion criteria
* Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301 (NCT00906399). * Subjects with any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease * Pregnant or nursing women. NOTE: Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | up to 4 years | 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. |
| Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | up to 4 years | 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. |
| Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years | 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. |
| Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years | 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. TSH=thyroid stimulating hormone. |
| Number of Participants With Shifts From Baseline: Urinalysis | Baseline (BIIB017 Treatment Baseline from Study 105MS301) up to 4 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of New Active Lesions | Week 48, Week 96 | 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. |
| Number of New T1 Hypointense Lesions | Week 48, Week 96 | The total number of new T1 hypointense lesions as assessed by MRI. |
| Number of Gd-Enhancing Lesions | Baseline (start of 105MS302), Week 48, Week 96 | 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. |
| Volume of T2 Hyperintense Lesions | Baseline (start of 105MS302), Week 48, Week 96 | 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. |
| Volume of T1 Hypointense Lesions | Baseline (start of 105MS302), Week 48, Week 96 | 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. |
| Volume of Gd-Enhancing Lesions | Baseline (start of 105MS302), Week 48, Week 96 | 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. |
| Percentage Change of Whole Brain Volume | Baseline (start of 105MS302), Week 48, Week 96 | 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. |
| Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 | 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. |
| Change From Baseline in Expanded Disability Status Scale (EDSS) | Baseline (start of 105MS302), Weeks 12, 24, 48, 72, 96, 120, 144, 168 | 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. |
| Time to Sustained Disability Progression | Weeks 12, 24, 28, 72, 96, 120, 144, 168 | 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. |
| Change From Baseline in Symbol Digit Modalities Test (SDMT) | Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 | 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). |
| Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 | 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. |
| Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 | 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. |
| Change From Baseline in SF-12 Physical Component Score (PCS) | Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 | 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. |
| Number of Relapses Requiring IV Steroid Use | up to 4 years | Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded. |
| Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS. | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation. | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections? | Year 1, Year 2, Year 3 | 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. |
| Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1, Year 2, Year 3 | 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. |
| Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Baseline (start of 105MS302), Weeks 24, 48, 72, 96, 120, 144, 168 | 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. |
| Annualized Relapse Rate (ARR) | up to 4 years | 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. |
| Number of MS-Related Hospitalizations | up to 4 years | Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded. |
| Percentage of Participants Who Relapsed | Up to 4 years | 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. |
| Number of New or Newly Enlarging T2 Hyperintense Lesions | Week 48, Week 96 | 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. |
Countries
Belgium, Bulgaria, Canada, Chile, Colombia, Croatia, Czechia, Estonia, France, Georgia, Germany, Greece, India, Latvia, Mexico, Netherlands, New Zealand, Peru, Poland, Romania, Russia, Serbia, Spain, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| BIIB017 Q4W 125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years. | 529 |
| BIIB017 Q2W 125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years. | 547 |
| Total | 1,076 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 13 | 22 |
| Overall Study | Death | 2 | 1 |
| Overall Study | Lost to Follow-up | 4 | 7 |
| Overall Study | Other | 16 | 18 |
| Overall Study | Physician Decision | 4 | 3 |
| Overall Study | Was Not Dosed | 1 | 0 |
| Overall Study | Withdrawal by Subject | 73 | 71 |
Baseline characteristics
| Characteristic | BIIB017 Q4W | BIIB017 Q2W | Total |
|---|---|---|---|
| Age, Continuous | 38.1 years STANDARD_DEVIATION 9.95 | 38.7 years STANDARD_DEVIATION 9.59 | 38.4 years STANDARD_DEVIATION 9.77 |
| Age, Customized 20-29 years | 131 participants | 107 participants | 238 participants |
| Age, Customized 30-39 years | 165 participants | 180 participants | 345 participants |
| Age, Customized 40-49 years | 150 participants | 172 participants | 322 participants |
| Age, Customized 50-59 years | 80 participants | 83 participants | 163 participants |
| Age, Customized 60-65 years | 3 participants | 5 participants | 8 participants |
| Gender Female | 378 Participants | 397 Participants | 775 Participants |
| Gender Male | 151 Participants | 150 Participants | 301 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 435 / 529 | 438 / 547 |
| serious Total, serious adverse events | 114 / 529 | 91 / 547 |
Outcome results
Primary
Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Any event | 471 participants |
| BIIB017 Q4W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Serious event | 113 participants |
| BIIB017 Q4W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Event related to study treatment | 400 participants |
| BIIB017 Q4W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Discontinuing study treatment due to an event | 18 participants |
| BIIB017 Q4W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Moderate or severe event | 343 participants |
| BIIB017 Q4W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Withdrawing from study due to an event | 14 participants |
| BIIB017 Q4W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Severe event | 74 participants |
| BIIB017 Q2W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Withdrawing from study due to an event | 23 participants |
| BIIB017 Q2W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Severe event | 73 participants |
| BIIB017 Q2W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Any event | 478 participants |
| BIIB017 Q2W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Event related to study treatment | 399 participants |
| BIIB017 Q2W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Serious event | 90 participants |
| BIIB017 Q2W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Discontinuing study treatment due to an event | 26 participants |
| BIIB017 Q2W | Number of Participants Experiencing Adverse Events (AEs) Serious AEs, and Discontinuations Due to AEs | Moderate or severe event | 348 participants |
Primary
Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Total absolute neutrophils < 1.5*10^9/L | 31 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Lymphocytes < 0.8*10^9/L | 41 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Segmented neutrophils ≤ 1*10^9/L | 8 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Lymphocytes < 0.5*10^9/L | 2 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Total absolute neutrophils ≥ 12*10^9/L | 18 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Lymphocytes > 12*10^9/L | 0 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Segmented neutrophils ≥ 12*10^9/L | 18 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Platelet count ≤ 100*10^9/L | 3 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Segmented neutrophils < 1.5*10^9/L | 31 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Red blood cells ≤ 3.3*10^12/L | 1 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Total absolute neutrophils ≤ 1*10^9/L | 8 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Red blood cells ≥ 6.8*10^12/L | 0 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | White blood cells ≥ 16.0*10^9/L | 13 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Hemoglobin ≤ 100 g/L | 33 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Platelet count ≥ 600*10^9/L | 2 participants |
| BIIB017 Q4W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | White blood cells < 3.0*10^9/L | 28 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Platelet count ≥ 600*10^9/L | 2 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Segmented neutrophils ≤ 1*10^9/L | 16 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Segmented neutrophils < 1.5*10^9/L | 84 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Segmented neutrophils ≥ 12*10^9/L | 5 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Total absolute neutrophils < 1.5*10^9/L | 83 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Hemoglobin ≤ 100 g/L | 35 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Platelet count ≤ 100*10^9/L | 11 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | White blood cells < 3.0*10^9/L | 86 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | White blood cells ≥ 16.0*10^9/L | 4 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Lymphocytes < 0.8*10^9/L | 62 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Lymphocytes < 0.5*10^9/L | 7 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Lymphocytes > 12*10^9/L | 0 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Total absolute neutrophils ≤ 1*10^9/L | 15 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Total absolute neutrophils ≥ 12*10^9/L | 5 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Red blood cells ≤ 3.3*10^12/L | 7 participants |
| BIIB017 Q2W | Number of Participants With Potentially Clinically Significant Hematology Laboratory Abnormalities | Red blood cells ≥ 6.8*10^12/L | 0 participants |
Primary
Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry
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. TSH=thyroid stimulating hormone.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Potassium: shift to low; n=527, 544 | 13 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Creatinine: shift to low; n=529, 547 | 0 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Potassium: shift to high; n=528, 546 | 17 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Bicarbonate: shift to low; n=523, 540 | 49 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Chloride: shift to low; n=529, 546 | 1 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Blood urea nitrogen: shift to low; n=529, 546 | 0 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Chloride: shift to high; n=528, 547 | 0 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Bicarbonate: shift to high; n=529, 544 | 0 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Glucose: shift to low; n=522, 539 | 54 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Creatinine: shift to high; n=528, 545 | 15 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Glucose: shift to high; n=506, 513 | 304 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Sodium: shift to low; n=529, 546 | 0 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | TSH: shift to low; n=515, 533 | 47 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Sodium: shift to high; n=524, 544 | 39 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | TSH: shift to high; n=518, 539 | 37 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Blood urea nitrogen: shift to high; n=527, 543 | 16 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | TSH: shift to high; n=518, 539 | 55 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Creatinine: shift to low; n=529, 547 | 1 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Sodium: shift to low; n=529, 546 | 3 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Blood urea nitrogen: shift to low; n=529, 546 | 1 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Creatinine: shift to high; n=528, 545 | 8 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Bicarbonate: shift to low; n=523, 540 | 64 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Bicarbonate: shift to high; n=529, 544 | 0 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Sodium: shift to high; n=524, 544 | 46 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Potassium: shift to low; n=527, 544 | 21 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Potassium: shift to high; n=528, 546 | 20 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Chloride: shift to low; n=529, 546 | 2 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Chloride: shift to high; n=528, 547 | 3 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Glucose: shift to low; n=522, 539 | 51 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Glucose: shift to high; n=506, 513 | 311 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | TSH: shift to low; n=515, 533 | 30 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Kidney Function and Other Blood Chemistry | Blood urea nitrogen: shift to high; n=527, 543 | 20 participants |
Primary
Number of Participants With Shifts From Baseline: Liver Function Laboratory Values
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | ALT: shift to low; n=528, 546 | 3 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | GGT: shift to low; n=529, 545 | 16 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | GGT: shift to high; n=512, 528 | 73 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Alkaline phosphatase: shift to high; n=516, 536 | 28 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Lactate dehydrogenase: shift to high; n=524, 541 | 18 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | ALT: shift to high; n=487, 497 | 119 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | AST: shift to low; n=528, 546 | 10 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | AST: shift to high; n=514, 530 | 75 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Total bilirubin: shift to low; n=512, 517 | 94 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Total bilirubin: shift to high; n=511, 535 | 22 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Alkaline phosphatase: shift to low; n=522, 543 | 4 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Lactate dehydrogenase: shift to low; n=529, 547 | 0 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Alkaline phosphatase: shift to low; n=522, 543 | 5 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | AST: shift to high; n=514, 530 | 110 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | GGT: shift to low; n=529, 545 | 6 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Alkaline phosphatase: shift to high; n=516, 536 | 26 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | GGT: shift to high; n=512, 528 | 97 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Total bilirubin: shift to low; n=512, 517 | 76 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Lactate dehydrogenase: shift to high; n=524, 541 | 30 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | ALT: shift to low; n=528, 546 | 3 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Total bilirubin: shift to high; n=511, 535 | 16 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | ALT: shift to high; n=487, 497 | 153 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | Lactate dehydrogenase: shift to low; n=529, 547 | 0 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Liver Function Laboratory Values | AST: shift to low; n=528, 546 | 8 participants |
Primary
Number of Participants With Shifts From Baseline: Urinalysis
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Ketones: shift to high/pos; n=510, 530 | 64 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Glucose: shift to high/pos; n=521, 542 | 28 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Protein: shift to high/pos; n=380, 391 | 270 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | pH: shift to high/pos; n=528, 547 | 6 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | RBC: shift to high/pos; n=419, 402 | 110 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Specific gravity: shift to high/pos; n=528,547 | 13 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | WBC: shift to high/pos; n=472, 495 | 116 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Color: shift to high/pos; n=516, 529 | 33 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Bilirubin: shift to high/pos; n=529, 547 | 0 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Specific gravity: shift to low; n=525, 545 | 2 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Nitrite: shift to high/pos; n=508, 519 | 84 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Blood: shift to high/pos; n=469, 495 | 159 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | Urobilinogen: shift to high/pos; n=529, 546 | 7 participants |
| BIIB017 Q4W | Number of Participants With Shifts From Baseline: Urinalysis | pH: shift to low; n=529, 547 | 0 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Urobilinogen: shift to high/pos; n=529, 546 | 13 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Specific gravity: shift to low; n=525, 545 | 1 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Specific gravity: shift to high/pos; n=528,547 | 3 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | pH: shift to low; n=529, 547 | 0 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | pH: shift to high/pos; n=528, 547 | 4 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Color: shift to high/pos; n=516, 529 | 36 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Glucose: shift to high/pos; n=521, 542 | 25 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Ketones: shift to high/pos; n=510, 530 | 73 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Protein: shift to high/pos; n=380, 391 | 277 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | RBC: shift to high/pos; n=419, 402 | 106 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | WBC: shift to high/pos; n=472, 495 | 130 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Bilirubin: shift to high/pos; n=529, 547 | 1 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Nitrite: shift to high/pos; n=508, 519 | 94 participants |
| BIIB017 Q2W | Number of Participants With Shifts From Baseline: Urinalysis | Blood: shift to high/pos; n=469, 495 | 167 participants |
Secondary
Annualized Relapse Rate (ARR)
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.
Time frame: up to 4 years
Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIIB017 Q4W | Annualized Relapse Rate (ARR) | 0.189 relapses per person-years |
| BIIB017 Q2W | Annualized Relapse Rate (ARR) | 0.142 relapses per person-years |
Comparison: Based on negative binomial regression for each treatment group, with adjustment for EDSS (\<4 vs. \>=4), relapse rate (based on 1 year before 105MS301 and 105MS301), and age (\<40 vs. \>=40) at 105MS302 baseline.p-value: 0.020395% CI: [0.595, 0.957]negative binomial regression
Secondary
Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Change at Week 168; n=20, 26 | 0.294 units on a scale | Standard Deviation 9.7505 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Baseline; n=527, 544 | 48.591 units on a scale | Standard Deviation 10.3624 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Change at Week 96; n=437, 452 | 0.014 units on a scale | Standard Deviation 8.8856 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Change at Week 24; n=514, 535 | -0.734 units on a scale | Standard Deviation 8.3567 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Change at Week 144; n=88, 98 | 0.110 units on a scale | Standard Deviation 8.0301 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Change at Week 48; n=498, 510 | -0.690 units on a scale | Standard Deviation 8.3903 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Change at Week 120; n=193, 205 | 0.616 units on a scale | Standard Deviation 7.5313 |
| BIIB017 Q2W | Change From Baseline in 12-Item Short Form Health Survey (SF-12) Mental Component Score (MCS) | Change at Week 72; n=474, 491 | -0.162 units on a scale | Standard Deviation 9.0676 |
Secondary
Change From Baseline in EQ-5D Visual Analogue Scale (VAS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Baseline; n=527, 542 | 77.07 units on a scale | Standard Deviation 17.623 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Change at Week 168; n=21, 26 | 0.46 units on a scale | Standard Deviation 12.602 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Baseline; n=527, 542 | 77.33 units on a scale | Standard Deviation 18.348 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Change at Week 96; n=436, 450 | -2.20 units on a scale | Standard Deviation 14.095 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Change at Week 24; n=511, 532 | -0.98 units on a scale | Standard Deviation 12.064 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Change at Week 144; n=88, 97 | -0.87 units on a scale | Standard Deviation 14.865 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Change at Week 48; n=498, 508 | -0.93 units on a scale | Standard Deviation 12.719 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Change at Week 120; n=193, 204 | -0.88 units on a scale | Standard Deviation 12.793 |
| BIIB017 Q2W | Change From Baseline in EQ-5D Visual Analogue Scale (VAS) | Change at Week 72; n=472, 490 | -1.89 units on a scale | Standard Deviation 15.27 |
Secondary
Change From Baseline in Euro Quality of Life (EQ-5D) Index Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Baseline; n=527, 544 | 0.76 units on a scale | Standard Deviation 0.23 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 0.19 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 0.08 |
| BIIB017 Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Change at Week 168; n=21, 26 | 0.02 units on a scale | Standard Deviation 0.137 |
| BIIB017 Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Baseline; n=527, 544 | 0.76 units on a scale | Standard Deviation 0.23 |
| BIIB017 Q2W | 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 0.195 |
| BIIB017 Q2W | 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 0.171 |
| BIIB017 Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Change at Week 144; n=88, 98 | 0.01 units on a scale | Standard Deviation 0.166 |
| BIIB017 Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Change at Week 48; n=498, 510 | 0.00 units on a scale | Standard Deviation 0.171 |
| BIIB017 Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Change at Week 120; n=193, 205 | 0.00 units on a scale | Standard Deviation 0.165 |
| BIIB017 Q2W | Change From Baseline in Euro Quality of Life (EQ-5D) Index Score | Change at Week 72; n=472, 491 | 0.00 units on a scale | Standard Deviation 0.179 |
Secondary
Change From Baseline in Expanded Disability Status Scale (EDSS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Baseline; n=516, 535 | 2.43 units on a scale | Standard Deviation 1.346 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 144; n=90, 98 | 0.23 units on a scale | Standard Deviation 0.72 |
| BIIB017 Q4W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 120; n=187, 205 | 0.19 units on a scale | Standard Deviation 0.7 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 168; n=21, 25 | 0.18 units on a scale | Standard Deviation 0.454 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Baseline; n=516, 535 | 2.35 units on a scale | Standard Deviation 1.299 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 12; n=503, 524 | 0.00 units on a scale | Standard Deviation 0.45 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 24; n=500, 519 | 0.00 units on a scale | Standard Deviation 0.486 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 48; n=488, 497 | 0.03 units on a scale | Standard Deviation 0.51 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 96; n=429, 446 | 0.09 units on a scale | Standard Deviation 0.563 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 120; n=187, 205 | 0.10 units on a scale | Standard Deviation 0.538 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 144; n=90, 98 | 0.10 units on a scale | Standard Deviation 0.587 |
| BIIB017 Q2W | Change From Baseline in Expanded Disability Status Scale (EDSS) | Change at Week 72; n=468, 484 | 0.06 units on a scale | Standard Deviation 0.484 |
Secondary
Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Baseline; n=527, 544 | 20.494 units on a scale | Standard Deviation 19.829 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Change at Week 168; n=20, 26 | -0.288 units on a scale | Standard Deviation 13.5615 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Baseline; n=527, 544 | 20.218 units on a scale | Standard Deviation 19.0264 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Change at Week 24; n=513, 534 | 0.552 units on a scale | Standard Deviation 10.0147 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Change at Week 48; n=498, 510 | 0.545 units on a scale | Standard Deviation 10.6342 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Change at Week 72; n=474, 491 | 0.684 units on a scale | Standard Deviation 12.469 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Change at Week 96; n=437, 452 | 1.190 units on a scale | Standard Deviation 11.4005 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Change at Week 144; n=88, 98 | 0.051 units on a scale | Standard Deviation 12.1417 |
| BIIB017 Q2W | Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Score | Change at Week 120; n=193, 205 | 0.116 units on a scale | Standard Deviation 10.4382 |
Secondary
Change From Baseline in SF-12 Physical Component Score (PCS)
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Change From Baseline in SF-12 Physical Component Score (PCS) | Baseline; n=527, 544 | 45.154 units on a scale | Standard Deviation 9.4474 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Change at Week 168; n=20, 26 | 0.152 units on a scale | Standard Deviation 7.5206 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Baseline; n=527, 544 | 44.902 units on a scale | Standard Deviation 9.9312 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Change at Week 96; n=437, 452 | -0.138 units on a scale | Standard Deviation 6.4453 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Change at Week 24; n=514, 535 | 0.337 units on a scale | Standard Deviation 5.7878 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Change at Week 144; n=88, 98 | 0.118 units on a scale | Standard Deviation 6.783 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Change at Week 48; n=498, 510 | 0.214 units on a scale | Standard Deviation 5.8377 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Change at Week 120; n=193, 205 | 0.021 units on a scale | Standard Deviation 6.1354 |
| BIIB017 Q2W | Change From Baseline in SF-12 Physical Component Score (PCS) | Change at Week 72; n=474, 491 | -0.169 units on a scale | Standard Deviation 6.3824 |
Secondary
Change From Baseline in Symbol Digit Modalities Test (SDMT)
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Baseline; n=523, 543 | 52.134 units on a scale | Standard Deviation 17.7653 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 144; n=88, 96 | -1.727 units on a scale | Standard Deviation 7.79 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 168; n=21, 25 | -3.840 units on a scale | Standard Deviation 13.4712 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 96; n=435, 450 | -0.231 units on a scale | Standard Deviation 9.3148 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 48; n=493, 509 | -0.864 units on a scale | Standard Deviation 8.6059 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 120; n=190, 203 | -1.099 units on a scale | Standard Deviation 9.5425 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 144; n=88, 96 | -0.906 units on a scale | Standard Deviation 10.8367 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Baseline; n=523, 543 | 52.744 units on a scale | Standard Deviation 17.6994 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 72; n=472, 489 | -1.012 units on a scale | Standard Deviation 8.5038 |
| BIIB017 Q2W | Change From Baseline in Symbol Digit Modalities Test (SDMT) | Change at Week 24; n=508, 530 | -1.106 units on a scale | Standard Deviation 8.1292 |
Secondary
Number of Gd-Enhancing Lesions
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Number of Gd-Enhancing Lesions | Baseline; n=528, 543 | 0.6 lesions | Standard Deviation 1.85 |
| BIIB017 Q4W | Number of Gd-Enhancing Lesions | Week 48; n=481, 493 | 0.7 lesions | Standard Deviation 2.07 |
| BIIB017 Q4W | Number of Gd-Enhancing Lesions | Week 96; n=411, 407 | 0.8 lesions | Standard Deviation 2.59 |
| BIIB017 Q2W | Number of Gd-Enhancing Lesions | Baseline; n=528, 543 | 0.2 lesions | Standard Deviation 1.07 |
| BIIB017 Q2W | Number of Gd-Enhancing Lesions | Week 48; n=481, 493 | 0.2 lesions | Standard Deviation 1.42 |
| BIIB017 Q2W | Number of Gd-Enhancing Lesions | Week 96; n=411, 407 | 0.2 lesions | Standard Deviation 0.89 |
Comparison: Week 48p-value: 0.0012Regression, Logistic
Comparison: Week 96p-value: 0.0026Regression, Logistic
Secondary
Number of MS-Related Hospitalizations
Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.
Time frame: up to 4 years
Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIIB017 Q4W | Number of MS-Related Hospitalizations | 113 hospitalizations |
| BIIB017 Q2W | Number of MS-Related Hospitalizations | 81 hospitalizations |
Secondary
Number of New Active Lesions
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Number of New Active Lesions | Week 48; n=481, 493 | 4.4 lesions | Standard Deviation 8.25 |
| BIIB017 Q4W | Number of New Active Lesions | Week 96; n=411, 406 | 9.0 lesions | Standard Deviation 16.88 |
| BIIB017 Q2W | Number of New Active Lesions | Week 48; n=481, 493 | 2.0 lesions | Standard Deviation 4.62 |
| BIIB017 Q2W | Number of New Active Lesions | Week 96; n=411, 406 | 3.9 lesions | Standard Deviation 9.47 |
Comparison: Week 48p-value: <0.000195% CI: [0.43, 0.68]negative binomial regression
Comparison: Week 96p-value: <0.000195% CI: [0.43, 0.71]negative binomial regression
Secondary
Number of New or Newly Enlarging T2 Hyperintense Lesions
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Number of New or Newly Enlarging T2 Hyperintense Lesions | Week 96; n=411, 407 | 8.9 lesions | Standard Deviation 16.64 |
| BIIB017 Q4W | Number of New or Newly Enlarging T2 Hyperintense Lesions | Week 48; n=481, 493 | 4.4 lesions | Standard Deviation 8.19 |
| BIIB017 Q2W | Number of New or Newly Enlarging T2 Hyperintense Lesions | Week 48; n=481, 493 | 1.9 lesions | Standard Deviation 4.5 |
| BIIB017 Q2W | Number of New or Newly Enlarging T2 Hyperintense Lesions | Week 96; n=411, 407 | 3.9 lesions | Standard Deviation 9.37 |
Comparison: Week 48p-value: <0.000195% CI: [0.41, 0.63]negative binomial regression
Comparison: Week 96p-value: <0.000195% CI: [0.39, 0.62]negative binomial regression
Secondary
Number of New T1 Hypointense Lesions
The total number of new T1 hypointense lesions as assessed by MRI.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Number of New T1 Hypointense Lesions | Week 49; n=481, 493 | 1.4 lesions | Standard Deviation 3.02 |
| BIIB017 Q4W | Number of New T1 Hypointense Lesions | Week 96; n=411, 406 | 2.8 lesions | Standard Deviation 5.92 |
| BIIB017 Q2W | Number of New T1 Hypointense Lesions | Week 49; n=481, 493 | 0.8 lesions | Standard Deviation 2.18 |
| BIIB017 Q2W | Number of New T1 Hypointense Lesions | Week 96; n=411, 406 | 1.5 lesions | Standard Deviation 4.14 |
Comparison: Week 48p-value: <0.0001Regression, Logistic
Comparison: Week 96p-value: <0.0001Regression, Logistic
Secondary
Number of Relapses Requiring IV Steroid Use
Observed data after participants switched to alternative MS medications or after Amendment 3 took effect are excluded.
Time frame: up to 4 years
Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIIB017 Q4W | Number of Relapses Requiring IV Steroid Use | 217 relapses |
| BIIB017 Q2W | Number of Relapses Requiring IV Steroid Use | 181 relapses |
Secondary
Percentage Change of Whole Brain Volume
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Percentage Change of Whole Brain Volume | Change at Week 48; n=402, 418 | -0.522 percentage change | Standard Deviation 0.6205 |
| BIIB017 Q4W | Percentage Change of Whole Brain Volume | Change at Week 96; n=365, 358 | -0.835 percentage change | Standard Deviation 1.0785 |
| BIIB017 Q2W | Percentage Change of Whole Brain Volume | Change at Week 48; n=402, 418 | -0.453 percentage change | Standard Deviation 0.8127 |
| BIIB017 Q2W | Percentage Change of Whole Brain Volume | Change at Week 96; n=365, 358 | -0.788 percentage change | Standard Deviation 1.1912 |
Secondary
Percentage of Participants Who Relapsed
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.
Time frame: Up to 4 years
Population: ITT population: all participants who were assigned a treatment and received at least 1 dose of study treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Percentage of Participants Who Relapsed | Did not relapse | 71 percentage of participants |
| BIIB017 Q4W | Percentage of Participants Who Relapsed | Relapsed | 29 percentage of participants |
| BIIB017 Q2W | Percentage of Participants Who Relapsed | Did not relapse | 77 percentage of participants |
| BIIB017 Q2W | Percentage of Participants Who Relapsed | Relapsed | 23 percentage of participants |
Comparison: q2w/q4wp-value: 0.020195% CI: [0.59, 0.96]Cox proportion hazards model
Secondary
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed?
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? | Year 1; n=482, 496 | 8.0 units on a scale | Standard Deviation 2.12 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? | Year 2; n=426, 430 | 8.2 units on a scale | Standard Deviation 2.05 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication as Instructed? | Year 3; n=82, 88 | 8.0 units on a scale | Standard Deviation 2.08 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks?
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? | Year 2; n=426, 430 | 8.4 units on a scale | Standard Deviation 2.06 |
| BIIB017 Q2W | 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 1.99 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Convenient or Inconvenient Is It to Take Your Medication Every 2 Weeks? | Year 3; n=82, 88 | 8.5 units on a scale | Standard Deviation 1.79 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication?
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? | Year 1; n=482, 496 | 8.6 units on a scale | Standard Deviation 2 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? | Year 2; n=426, 430 | 8.3 units on a scale | Standard Deviation 2.58 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Likely Would You Be to Continue to Use This Medication? | Year 3; n=82, 88 | 8.8 units on a scale | Standard Deviation 2 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)?
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? | Year 1; n=482, 496 | 8.3 units on a scale | Standard Deviation 1.98 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? | Year 2; n=426, 430 | 8.3 units on a scale | Standard Deviation 2.07 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Satisfied or Dissatisfied Are You With the Injection Frequency (Every 2 Weeks)? | Year 3; n=82, 88 | 8.6 units on a scale | Standard Deviation 1.59 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication?
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? | Year 1; n=482, 496 | 7.0 units on a scale | Standard Deviation 2.21 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? | Year 2; n=425, 430 | 7.1 units on a scale | Standard Deviation 2.27 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: How Tolerable or Intolerable Do You Find the Medication? | Year 3; n=82, 88 | 7.3 units on a scale | Standard Deviation 2.17 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. | Year 1; n=482, 496 | 8.5 units on a scale | Standard Deviation 1.94 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. | Year 2; n=425, 430 | 8.5 units on a scale | Standard Deviation 2.06 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: I Am Satisfied With the Dosing Frequency of This Medication. | Year 3; n=82, 88 | 8.7 units on a scale | Standard Deviation 1.81 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: medication side effects; n=8, 6 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: injection pain; n=8, 6 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: forget to take medication; n=8, 6 | 2 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: tired of taking injections; n=8, 6 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: don't think medication is working; n=8, 6 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: other; n=8, 6 | 6 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: medication side effects; n=4, 3 | 1 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: injection pain; n=4, 3 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: forget to take medication; n=4, 3 | 1 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: tired of taking injections; n=4, 3 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: don't think medication is working; n=4, 3 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: other; n=4, 3 | 2 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: medication side effects; n=2, 2 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: injection pain; n=2, 2 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: forget to take medication; n=2, 2 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: tired of taking injections; n=2, 2 | 1 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: don't think medication is working; n=2, 2 | 0 participants |
| BIIB017 Q4W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: other; n=2, 2 | 1 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: injection pain; n=2, 2 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: medication side effects; n=8, 6 | 1 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: tired of taking injections; n=4, 3 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: injection pain; n=8, 6 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: other; n=2, 2 | 1 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: forget to take medication; n=8, 6 | 1 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: don't think medication is working; n=4, 3 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: tired of taking injections; n=8, 6 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: forget to take medication; n=2, 2 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: don't think medication is working; n=8, 6 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: other; n=4, 3 | 1 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 1: other; n=8, 6 | 4 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: don't think medication is working; n=2, 2 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: medication side effects; n=4, 3 | 1 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: medication side effects; n=2, 2 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: injection pain; n=4, 3 | 0 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 3: tired of taking injections; n=2, 2 | 1 participants |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Main Reason for Missed Injections | Year 2: forget to take medication; n=4, 3 | 1 participants |
Secondary
Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication?
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? | Year 1; n=482, 496 | 8.1 units on a scale | Standard Deviation 1.97 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? | Year 2; n=426, 430 | 8.3 units on a scale | Standard Deviation 2 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: Overall, How Satisfied or Dissatisfied Are You With This Medication? | Year 3; n=82, 88 | 8.6 units on a scale | Standard Deviation 1.6 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: Over the Past 4 Weeks, Did You Miss Any of Your Injections?
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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | 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 | 1 participants |
| BIIB017 Q2W | 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 | 487 participants |
| BIIB017 Q2W | 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 | 4 participants |
| BIIB017 Q2W | 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 | 2 participants |
| BIIB017 Q2W | 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 | 426 participants |
| BIIB017 Q2W | 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 | 2 participants |
| BIIB017 Q2W | 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 |
| BIIB017 Q2W | 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 | 86 participants |
| BIIB017 Q2W | 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 | 1 participants |
Secondary
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 2.2 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. | Year 2; n=426, 430 | 8.2 units on a scale | Standard Deviation 2.12 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. | Year 1; n=482, 496 | 8.2 units on a scale | Standard Deviation 2.09 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Enables Me to Be More Spontaneous and Flexible. | Year 3; n=82, 88 | 8.4 units on a scale | Standard Deviation 1.93 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: The Twice a Month Dosing Makes It More Convenient for Me to Travel/Vacation.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 2.2 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | 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 2.13 |
| BIIB017 Q2W | 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 | 8.2 units on a scale | Standard Deviation 2.21 |
| BIIB017 Q2W | 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 | 8.5 units on a scale | Standard Deviation 1.86 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: This Medication Enables Me to Focus More on Myself and My Family Rather Than My MS.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | 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 | 7.8 units on a scale | Standard Deviation 2.21 |
| BIIB017 Q2W | 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 2.31 |
| BIIB017 Q2W | 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 | 8.3 units on a scale | Standard Deviation 2 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 2.5 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. | Year 1; n=482, 496 | 7.7 units on a scale | Standard Deviation 2.29 |
| BIIB017 Q2W | 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 2.31 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: This Medication Improves My Self-Confidence and Self-Reliance. | Year 3; n=82, 88 | 8.4 units on a scale | Standard Deviation 1.98 |
Secondary
Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities.
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q4W | 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 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. | Year 1; n=482, 496 | 7.7 units on a scale | Standard Deviation 2.33 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. | Year 2; n=426, 429 | 7.7 units on a scale | Standard Deviation 2.35 |
| BIIB017 Q2W | Summary of Participant-Reported Treatment Satisfaction: This Medication Makes It Easy For Me to Carry Out My Daily Responsibilities. | Year 3; n=82, 88 | 8.3 units on a scale | Standard Deviation 2.07 |
Secondary
Time to Sustained 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.
Time frame: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 12 weeks | 0.023 proportion of participants |
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 24 weeks | 0.046 proportion of participants |
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 48 weeks | 0.079 proportion of participants |
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 72 weeks | 0.103 proportion of participants |
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 96 weeks | 0.115 proportion of participants |
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 120 weeks | 0.147 proportion of participants |
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 144 weeks | 0.161 proportion of participants |
| BIIB017 Q4W | Time to Sustained Disability Progression | Progressed at 168 weeks | NA proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 168 weeks | NA proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 96 weeks | 0.069 proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 12 weeks | 0.007 proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 24 weeks | 0.023 proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 144 weeks | 0.096 proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 48 weeks | 0.045 proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 120 weeks | 0.085 proportion of participants |
| BIIB017 Q2W | Time to Sustained Disability Progression | Progressed at 72 weeks | 0.057 proportion of participants |
p-value: 0.00695% CI: [0.38, 0.85]Cox Proportional Hazards model
Secondary
Volume of Gd-Enhancing Lesions
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Volume of Gd-Enhancing Lesions | Baseline; n=528, 543 | 0.0911 cm^3 | Standard Deviation 0.30013 |
| BIIB017 Q4W | Volume of Gd-Enhancing Lesions | Week 48; n=481, 493 | 0.1172 cm^3 | Standard Deviation 0.42762 |
| BIIB017 Q4W | Volume of Gd-Enhancing Lesions | Week 96; n=411, 407 | 0.1346 cm^3 | Standard Deviation 0.5058 |
| BIIB017 Q2W | Volume of Gd-Enhancing Lesions | Baseline; n=528, 543 | 0.0348 cm^3 | Standard Deviation 0.17344 |
| BIIB017 Q2W | Volume of Gd-Enhancing Lesions | Week 48; n=481, 493 | 0.0477 cm^3 | Standard Deviation 0.31479 |
| BIIB017 Q2W | Volume of Gd-Enhancing Lesions | Week 96; n=411, 407 | 0.0357 cm^3 | Standard Deviation 0.14976 |
Secondary
Volume of T1 Hypointense Lesions
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Volume of T1 Hypointense Lesions | Baseline; n=528, 543 | 3.9869 cm^3 | Standard Deviation 6.29557 |
| BIIB017 Q4W | Volume of T1 Hypointense Lesions | Week 48; n=481, 493 | 4.3062 cm^3 | Standard Deviation 6.92839 |
| BIIB017 Q4W | Volume of T1 Hypointense Lesions | Week 96; n=411, 407 | 4.3171 cm^3 | Standard Deviation 6.70107 |
| BIIB017 Q2W | Volume of T1 Hypointense Lesions | Baseline; n=528, 543 | 3.6320 cm^3 | Standard Deviation 5.47465 |
| BIIB017 Q2W | Volume of T1 Hypointense Lesions | Week 48; n=481, 493 | 3.6529 cm^3 | Standard Deviation 5.19027 |
| BIIB017 Q2W | Volume of T1 Hypointense Lesions | Week 96; n=411, 407 | 3.7494 cm^3 | Standard Deviation 5.21314 |
Secondary
Volume of T2 Hyperintense Lesions
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB017 Q4W | Volume of T2 Hyperintense Lesions | Baseline; n=528, 543 | 11.4742 cm^3 | Standard Deviation 13.55811 |
| BIIB017 Q4W | Volume of T2 Hyperintense Lesions | Week 48; n=481, 493 | 11.7421 cm^3 | Standard Deviation 13.91774 |
| BIIB017 Q4W | Volume of T2 Hyperintense Lesions | Week 96; n=411, 407 | 12.0257 cm^3 | Standard Deviation 13.91056 |
| BIIB017 Q2W | Volume of T2 Hyperintense Lesions | Baseline; n=528, 543 | 9.9678 cm^3 | Standard Deviation 11.41807 |
| BIIB017 Q2W | Volume of T2 Hyperintense Lesions | Week 48; n=481, 493 | 9.8335 cm^3 | Standard Deviation 11.05029 |
| BIIB017 Q2W | Volume of T2 Hyperintense Lesions | Week 96; n=411, 407 | 9.9487 cm^3 | Standard Deviation 10.97208 |