Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis
Conditions
Brief summary
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). Secondary objectives of this study in this study population are as follows: To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).
Detailed description
Enrollment will include up to 1600 Participants, this includes approximately 1200 Participants who completed Study 205MS301 (NCT01064401). Additionally, approximately 400 Participants from the other BIIB019 extension studies 205MS203 (NCT01051349) and 205MS302 (NCT01462318) will be eligible to enter Study 205MS303 at Week 144 of Study 205MS303 \[Study 205MS301 (NCT01064401), study 205MS203 (NCT01051349) and study 205MS302 (NCT01462318) have been referred to as parent studies in the protocol\]. All Participants will receive the same dose of DAC HYP as received in the parent studies; i.e., 150 mg by an SC injection every 4 weeks.
Interventions
Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
Sponsors
AbbVie
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject currently participating in Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) who has completed End of Study Visit (Week 96 or later). * Women of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment. Key
Exclusion criteria
* Any subject who permanently discontinued study treatment in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). * Any significant change in the subject's medical history that would preclude administration of BIIB019, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318). The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS303. NOTE: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 301, calculated using the negative binomial model. |
| Number of Participants With Relapse in the 205MS303 Treatment Period | Up to 4.6 years in the 303 study | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. |
| Number of Participants With Relapse in the 205MS301-303 Combined Study Period | Up to 5.6 years combining 303 with the initial Study 301 | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. |
| Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | Up to 4.6 years in Study 303 | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 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. Higher scores indicate more disability. |
| Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | Up to 5.6 years combining 303 with the initial Study 301 | Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 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. Higher scores indicate more disability. |
| Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 | T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported. |
| Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Baseline 301, Weeks 24, 96, 144 in Study 301 | T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported. |
| Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96 | Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader. |
| Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Baseline 301, Weeks 24, 96 and 144 | Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader. |
| Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 | T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported. |
| Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | Baseline 301, Weeks 24, 96, 144 in Study 301 | T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported . |
| Percent Change in Brain Volume From the 205MS303 Baseline | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303 | To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement. |
| Percent Change in Brain Volume From 205MS301 Baseline | Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303 | To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement. |
| Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96 | Volume of T2 hyperintense Lesions was evaluated by MRI and was analyzed by a central MRI reader. |
| Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Baseline 303, Weeks 12, 24 and 48 in Study 303 | MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement. |
| Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study | MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement. |
| Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303 | The EDSS measures the disability status of people with multiple sclerosis as assessed by the Study Neurologist based on 8 functional systems that ranges from 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. Higher scores indicate more disability. A negative change from Baseline indicates improvement. |
| Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period | Up to 4.6 years in Study 303 | Participants without clinical or radiological activity are defined as disease-free. Clinical activity includes assessment of relapses and of disease progression. Radiological activity includes assessments of Gd+ lesions and new or enlarging T2 lesions. |
| Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Baseline 303, Weeks 12, 24, 48, 96, 120 and 144 | The 29-item MSIS-29 is a disease specific participant-reported outcome measure that has been developed and validated to examine the physical (coordination and mobility) and psychological (mental) impact of MS from a participant's perspective; it measures 20 physical items and 9 psychological items. The results for each of the physical and psychological scores are transformed to a score of 0 to 100 (worse state of health). A negative change from Baseline indicates improvement. |
| Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303 | The EQ-5D is a self-administered questionnaire consisting of 5 domains pertaining to specific health state profile : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participants recorded their level of current health for each domain where: 1=no problems, 2=some problem and 3=severe problems. The health score is derived from the individual scores for each of the 5 domains transformed to a score of 0=worst health state to 1=perfect health state. A positive change from Baseline indicates improvement. |
| Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303 | The participant rated their current heath state using the EQ VAS 20-centimeter horizontal line from 0 (worst imaginable health state) to 100 (best imaginable health state). A positive change from baseline indicates improvement. |
| Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303 | Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits. |
| Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301 | Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits. |
| Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303 | Participants answered the question: How satisfied or dissatisfied are you with the ability of the medication to prevent or treat the condition? using the following scale: Dissatisfied (Extremely dissatisfied, Very dissatisfied, Dissatisfied) or Satisfied (Somewhat satisfied, Satisfied, Very Satisfied and Extremely satisfied). The number of participants in the Dissatisfied and Satisfied categories is reported. |
| Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded their scheduled work hours. Data is reported by part time or full time employment. |
| HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded whether their MS or its treatments caused them to miss work. Data is reported by part time or full time employment. |
| HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded the hours they missed work due to MS or its treatments. Data is reported by part time or full time employment. |
| HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participants assessed the percent impact of MS and its treatments on their work output using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. Data is reported for part time or full time employment. |
| HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded their planned hours for household chores. |
| HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded whether MS or its treatments kept them from completing household chores. |
| HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded the hours where they were not able to perform household chores due to MS or its treatments. |
| HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303 | The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant assessed the percent impact of MS and its treatments on how much they accomplished using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. |
| Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period | Up to 4.6 years in 303 | Clinical Laboratory assessments included tests of hematology, blood chemistry, renal function, and thyroid function. The investigator determined if the results were clinically significant. |
| Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS | After the first and fourth injections in 303, approximately Week 0 and Week 12 | The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end: 0 =no pain on the left and 100=very painful on the right. The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain. |
| Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | After the first and fourth injections in 303, approximately Week 0 and Week 12 | The investigator assessed the injection site after the first dose and before the fourth dose for the presence of erythema (None, Mild, Moderate, Severe), pigmentation (None, Hypo, Hyper), Induration (None, Mild, Moderate, Severe), Tenderness (None, Mild, Moderate, Severe) and Temperature (Normal, Warm, Hot). The number of participants in each grade is reported. |
| Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period | Up to 4.6 years in the 303 Treatment Period | Blood samples were collected for ADAbs and were analyzed using a laboratory test. The number of participants ADAb positive at any post-baseline timepoint is reported. |
| Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | Up to 4.6 years in the 303 study | Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 205MS301, calculated using the negative binomial model. |
| Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Baseline 303, Weeks 144, 168, 192, 240 in 303 | 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 to 110 (best). A positive change from baseline indicates improvement. |
| Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303 | 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 to 110 (best). A positive change from baseline indicates improvement. |
| Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303 | The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement. |
| Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study | The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement. |
| Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period | Up to 4.6 years in the 303 Treatment Period | Blood samples were collected for NAbs and were analyzed using a laboratory test. The number of participants NAb positive at any post-baseline timepoint is reported. |
Countries
Argentina, Australia, Brazil, Canada, Czechia, Denmark, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Mexico, Moldova, Poland, Romania, Russia, Serbia, Spain, Sweden, Switzerland, Ukraine, United Kingdom, United States
Participant flow
Recruitment details
Participants were enrolled in the study at 226 investigative sites in 28 countries (United States, Canada, Western European countries, Australia, Israel, Eastern European countries, Argentina, Brazil, India, and Mexico) from 15 February 2013 to 24 September 2018.
Pre-assignment details
Participants who completed studies: 205MS301 (NCT01064401), 205MS203 (NCT01051349), 205MS302 (NCT01462318) were eligible to enroll in this long-term extension study.
Participants by arm
| Arm | Count |
|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 4.6 years in this long-term extension study 303; includes participants who previously received interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly in study 301 every 4 weeks for up to 144 weeks. | 597 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) Daclizumab High Yield Process (DAC HYP)150 mg subcutaneous (SC) injection every 4 weeks for up to 4.6 years in this long-term extension study 205MS303 (303); includes participants who previously received DAC HYP 150 mg SC injection in Study 205MS301 (301) every 4 weeks for up to 144 weeks. | 606 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 93.7 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS302 (302) every 4 weeks for up to 24 weeks followed by a 20-week washout period then continued treatment for up to an additional 3 years. | 70 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) DAC HYP 150 mg SC injection every 4 weeks for up to 94. 1 weeks in this long-term extension study 303 (participants started at Week 144 of the study); includes participants who previously received DAC HYP 150 mg SC injection in study 205MS203 (203) every 4 weeks for up to 288 weeks. | 227 |
| Total | 1,500 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 104 | 129 | 4 | 21 |
| Overall Study | Consent withdrawn | 130 | 117 | 3 | 35 |
| Overall Study | Death | 2 | 4 | 0 | 0 |
| Overall Study | Disease progression, defined by protocol | 3 | 1 | 0 | 0 |
| Overall Study | Investigator decision | 21 | 15 | 0 | 0 |
| Overall Study | Lost to Follow-up | 9 | 8 | 1 | 2 |
| Overall Study | Reason Not Specified | 280 | 295 | 0 | 15 |
Baseline characteristics
| Characteristic | IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Total |
|---|---|---|---|---|---|
| Age, Customized Adults (18-64 years) | 597 Participants | 606 Participants | 70 Participants | 227 Participants | 1500 Participants |
| Race/Ethnicity, Customized Asian | 11 Participants | 10 Participants | 0 Participants | 4 Participants | 25 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 5 Participants | 3 Participants | 0 Participants | 13 Participants |
| Race/Ethnicity, Customized Not Reported | 17 Participants | 18 Participants | 64 Participants | 0 Participants | 99 Participants |
| Race/Ethnicity, Customized Other | 18 Participants | 14 Participants | 1 Participants | 0 Participants | 33 Participants |
| Race/Ethnicity, Customized White | 546 Participants | 559 Participants | 2 Participants | 223 Participants | 1330 Participants |
| Sex: Female, Male Female | 394 Participants | 400 Participants | 42 Participants | 130 Participants | 966 Participants |
| Sex: Female, Male Male | 203 Participants | 206 Participants | 28 Participants | 97 Participants | 534 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 597 | 4 / 606 | 0 / 70 | 0 / 227 |
| other Total, other adverse events | 463 / 597 | 476 / 606 | 42 / 70 | 116 / 227 |
| serious Total, serious adverse events | 157 / 597 | 190 / 606 | 15 / 70 | 38 / 227 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product. A SAE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability / incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria.
Time frame: First dose of study drug in Study 303 to within 180 days of last dose (up to approximately 5.5 years)
Population: Safety Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AEs | 541 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 157 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 190 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AEs | 560 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AEs | 172 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 38 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with AEs | 53 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Participants with SAEs | 15 Participants |
Secondary
Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative multiple sclerosis (MS) medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, Expanded Disability Status Scale (EDSS) (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 205MS301, calculated using the negative binomial model.
Time frame: Up to 4.6 years in the 303 study
Population: Intent-to-treat (ITT) Population consisted of all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP during Study 303.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | 0.158 relapses per year |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | 0.163 relapses per year |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | 0.080 relapses per year |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Annualized Relapse Rate (ARR) in the 205MS303 Treatment Period | 0.167 relapses per year |
Secondary
ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist. The unadjusted ARR was calculated by tabulating the total number of relapses experienced in the group divided by the number of days up to the end of study, and the ratio then multiplied by 365.25. Relapses that occurred after participants received alternative MS medications were excluded from the analyses. ARR was adjusted for relapse rate, IFN beta use, EDSS (\<=2.5 vs \>2.5) and age (\<=35 vs \>35) prior to start of study treatment in 301, calculated using the negative binomial model.
Time frame: Up to 5.6 years combining 303 with the initial Study 301; Up to 1 year in the 301 study
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | 301-303 Combined Study Period | 0.247 relapses per year |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | 301 Treatment Period | 0.317 relapses per year |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | 301 Treatment Period | 0.195 relapses per year |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | ARR in the 205MS301-303 Combined Study Period and 205MS301 Treatment Period | 301-303 Combined Study Period | 0.175 relapses per year |
Secondary
Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period
MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement.
Time frame: Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48 in the 303 study
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed: Number of participants with data available at given timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 60 for 301 | 0.06893 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 303 | 0.07140 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 72 for 301 | 0.08645 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 84 for 301 | 0.05704 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 96 for 301 | 0.06731 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 108 for 301 | 0.08020 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 120 for 301 | 0.08406 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 132 for 301 | 0.07712 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 144 for 301 | 0.09674 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Baseline 303 | 0.06638 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 303 | 0.06449 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 303 | 0.05533 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Baseline 301 | 0.14629 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 301 | -0.00133 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 301 | 0.02377 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 36 for 301 | 0.04764 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 301 | 0.06491 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 301 | 0.07793 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 144 for 301 | 0.12943 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 301 | 0.04728 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 60 for 301 | 0.08973 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 156 for 301 | -0.0272 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 36 for 301 | 0.05771 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Baseline 303 | 0.11003 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 72 for 301 | 0.08690 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 301 | 0.02593 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 84 for 301 | 0.10283 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 303 | 0.09616 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 96 for 301 | 0.11283 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 303 | 0.12955 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 108 for 301 | 0.09868 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Baseline 301 | 0.14298 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 120 for 301 | 0.10367 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 303 | 0.09332 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the MSFC Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 132 for 301 | 0.08682 z-score |
Comparison: Change from Baseline 301 to Week 12 for 301p-value: 0.0204ANCOVA
Comparison: Change from Baseline 301 to Week 24 for 301p-value: 0.0805ANCOVA
Comparison: Change from Baseline 301 to Week 36 for 301p-value: 0.2535ANCOVA
Comparison: Change from Baseline 301 to Week 48 for 301p-value: 0.4738ANCOVA
Comparison: Change from Baseline 301 to Week 60 for 301p-value: 0.2302ANCOVA
Comparison: Change from Baseline 301 to Week 72 for 301p-value: 0.8522ANCOVA
Comparison: Change from Baseline 301 to Week 84 for 301p-value: 0.0431ANCOVA
Comparison: Change from Baseline 301 to Week 96 for 301p-value: 0.0339ANCOVA
Comparison: Change from Baseline 301 to Week 108 for 301p-value: 0.3195ANCOVA
Comparison: Change from Baseline 301 to Week 120 for 301p-value: 0.2119ANCOVA
Comparison: Change from Baseline 301 to Week 132 for 301p-value: 0.3619ANCOVA
Comparison: Change from Baseline 301 to Week 144 for 301p-value: 0.017ANCOVA
Comparison: Change from Baseline 301 to Baseline 303p-value: 0.017ANCOVA
Comparison: Change from Baseline 301 to Week 12 for 303p-value: 0.0849ANCOVA
Comparison: Change from Baseline 301 to Week 24 for 303p-value: 0.0057ANCOVA
Comparison: Change from Baseline 301 to Week 48 for 303p-value: 0.396ANCOVA
Secondary
Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period
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 to 110 (best). A positive change from baseline indicates improvement.
Time frame: Baseline 301, Weeks 24, 48, 72, 96, 120, 144 in 301; Weeks 144, 168, 192, 216, 240 in 303
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 24 for 301 | 1.3 score on a scale | Standard Deviation 11.2 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 144 for 301 | 3.2 score on a scale | Standard Deviation 13.38 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 72 for 301 | 3.0 score on a scale | Standard Deviation 13.12 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 144 for 303 | 0.7 score on a scale | Standard Deviation 14.95 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Baseline 301 | 47.8 score on a scale | Standard Deviation 16.18 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 168 for 303 | 2.0 score on a scale | Standard Deviation 14.78 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 96 for 301 | 3.0 score on a scale | Standard Deviation 13.04 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 192 for 303 | 1.7 score on a scale | Standard Deviation 15.81 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 216 for 303 | 4.7 score on a scale | Standard Deviation 15.91 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 48 for 301 | 2.7 score on a scale | Standard Deviation 12.31 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 240 for 303 | 3.8 score on a scale | Standard Deviation 11.41 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 120 for 301 | 3.5 score on a scale | Standard Deviation 13.53 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 240 for 303 | 8.8 score on a scale | Standard Deviation 9.42 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Baseline 301 | 48.4 score on a scale | Standard Deviation 16.32 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 24 for 301 | 1.1 score on a scale | Standard Deviation 12.42 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 48 for 301 | 2.2 score on a scale | Standard Deviation 12.01 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 72 for 301 | 3.6 score on a scale | Standard Deviation 12.98 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 96 for 301 | 4.1 score on a scale | Standard Deviation 13.09 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 120 for 301 | 5.4 score on a scale | Standard Deviation 12.75 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 144 for 301 | 6.6 score on a scale | Standard Deviation 13.15 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 144 for 303 | 1.3 score on a scale | Standard Deviation 13.92 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 168 for 303 | 1.6 score on a scale | Standard Deviation 14.86 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 216 for 303 | 4.5 score on a scale | Standard Deviation 14.59 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS301 Baseline in the SDMT Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 at Week 192 for 303 | 2.1 score on a scale | Standard Deviation 15.35 |
Secondary
Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period
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 to 110 (best). A positive change from baseline indicates improvement.
Time frame: Baseline 303, Weeks 144, 168, 192, 240 in 303
Population: ITT Population: All participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data is collected for participants from 203 and 302 studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Baseline 303 | 52.0 score on a scale | Standard Deviation 15.13 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 192 | -2.5 score on a scale | Standard Deviation 12.02 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 168 | -1.9 score on a scale | Standard Deviation 11.59 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 240 | 2.0 score on a scale | Standard Deviation 10.78 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 144 | -3.0 score on a scale | Standard Deviation 11.38 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 240 | -2.0 score on a scale | Standard Deviation 15.38 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 144 | -3.5 score on a scale | Standard Deviation 11.91 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Baseline 303 | 52.4 score on a scale | Standard Deviation 16.08 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 168 | -3.7 score on a scale | Standard Deviation 13.1 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From 205MS303 Baseline in the Symbol Digit Modalities Test (SDMT) Score in the 205MS303 Treatment Period | Change at Week 192 | -2.8 score on a scale | Standard Deviation 12.92 |
Secondary
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period
The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement.
Time frame: Baseline 301, Weeks 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156 in the 301 study, Baseline 303, Weeks 12, 24, 48, 120, 144,168, 192, 216, 240 in 303 study
Population: 301-303 ITT Population consisted of all participants who completed study 301 and had at least 1 dose of DAC HYP during study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 240 for 303 | 1.5 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 72 for 301 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Baseline 301 | 50.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 84 for 301 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 192 for 303 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 96 for 301 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 301 | 0.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 108 for 301 | 1.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 120 for 303 | 15.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 120 for 301 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 301 | 0.5 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 132 for 301 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 216 for 303 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 144 for 301 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 36 for 301 | 1.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 168 for 303 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Baseline 303 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 301 | 1.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 303 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 144 for 303 | 1.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 303 | 2.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 60 for 301 | 1.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Baseline 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 120 for 303 | 3.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 144 for 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 168 for 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 192 for 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 216 for 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 240 for 303 | 0.5 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Baseline 301 | 51.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 301 | 1.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 24 for 301 | 1.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 36 for 301 | 1.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 301 | 1.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 60 for 301 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 72 for 301 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 84 for 301 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 96 for 301 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 108 for 301 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 120 for 301 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 132 for 301 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 144 for 301 | 3.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 156 for 301 | -4.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 48 for 303 | 2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS301-303 Combined Study Period | Change from Baseline 301 to Week 12 for 303 | 2.0 score on a scale |
Comparison: Change from Baseline 301 to Week 12 for 301p-value: 0.2567ANCOVA
Comparison: Change from Baseline 301 to Week 24 for 301p-value: 0.6152ANCOVA
Comparison: Change from Baseline 301 to Week 36 for 301p-value: 0.2024ANCOVA
Comparison: Change from Baseline 301 to Week 48 for 301p-value: 0.9988ANCOVA
Comparison: Change from Baseline 301 to Week 60 for 301p-value: 0.7962ANCOVA
Comparison: Change from Baseline 301 to Week 72 for 301p-value: 0.8486ANCOVA
Comparison: Change from Baseline 301 to Week 84 for 301p-value: 0.4478ANCOVA
Comparison: Change from Baseline 301 to Week 96 for 301p-value: 0.325ANCOVA
Comparison: Change from Baseline 301 to Week 108 for 301p-value: 0.129ANCOVA
Comparison: Change from Baseline 301 to Week 120 for 301p-value: 0.7295ANCOVA
Comparison: Change from Baseline 301 to Week 132 for 301p-value: 0.8647ANCOVA
Comparison: Change from Baseline 301 to Week 144 for 301p-value: 0.2183ANCOVA
Comparison: Change from Baseline 301 to Baseline 303p-value: 0.3945ANCOVA
Comparison: Change from Baseline 301 to Week 12 for 303p-value: 0.5068ANCOVA
Comparison: Change from Baseline 301 to Week 24 for 303p-value: 0.1669ANCOVA
Comparison: Change from Baseline 301 to Week 48 for 303p-value: 0.5038ANCOVA
Comparison: Change from Baseline 301 to Week 144 for 303p-value: 0.6001ANCOVA
Comparison: Change from Baseline 301 to Week 168 for 303p-value: 0.8617ANCOVA
Comparison: Change from Baseline 301 to Week 192 for 303p-value: 0.259ANCOVA
Comparison: Change from Baseline 301 to Week 216 for 303p-value: 0.5159ANCOVA
Comparison: Change from Baseline 301 to Week 240 for 303p-value: 0.6123ANCOVA
Secondary
Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period
The PASAT 3 assesses auditory information processing speed. A random series of numbers from 1 to 9, inclusive, are presented and the participant is instructed to consecutively add pairs of numbers so that each number is added to the one that immediately preceded it. In the 3- second PASAT, numbers are presented at a rate of 1 every 3 seconds. The total possible score is the number of correct responses from 0 to 60 (best). A positive change from baseline indicates improvement.
Time frame: Baseline 303, Weeks 12, 24, 48, 120, 144, 168, 192, 216, 240 in 303
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Baseline 303 | 54.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 12 | 0.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 24 | 0.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 48 | 0.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 120 | -3.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 144 | -1.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 168 | 0.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 192 | 0.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 216 | 0.0 score on a scale |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 240 | 0.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 192 | 0.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Baseline 303 | 54.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 144 | -1.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 12 | 0.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 240 | -2.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 24 | 0.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 168 | 0.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 48 | 0.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 216 | 0.0 score on a scale |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in 3-Second Paced Auditory Serial Addition Test (PASAT 3) Score in the 205MS303 Treatment Period | Change to Week 120 | -1.0 score on a scale |
Comparison: Change to Week 12p-value: 0.3813ANCOVA
Comparison: Change to Week 24p-value: 0.1679ANOVA
Comparison: Change to Week 48p-value: 0.5634ANCOVA
Comparison: Change to Week 144p-value: 0.7003ANCOVA
Comparison: Change to Week 168p-value: 0.7812ANCOVA
Comparison: Change to Week 192p-value: 0.3246ANCOVA
Comparison: Change to Week 216p-value: 0.6423ANCOVA
Comparison: Change to Week 240p-value: 0.0288ANCOVA
Secondary
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period
The EQ-5D is a self-administered questionnaire consisting of 5 domains pertaining to specific health state profile : mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participants recorded their level of current health for each domain where: 1=no problems, 2=some problem and 3=severe problems. The health score is derived from the individual scores for each of the 5 domains transformed to a score of 0=worst health state to 1=perfect health state. A positive change from Baseline indicates improvement.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 12 | 0.01 score on a scale | Standard Deviation 0.168 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 192 | 0.00 score on a scale | Standard Deviation 0.187 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 24 | 0.01 score on a scale | Standard Deviation 0.171 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 96 | 0.00 score on a scale | Standard Deviation 0.168 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 48 | -0.01 score on a scale | Standard Deviation 0.185 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 144 | 0.01 score on a scale | Standard Deviation 0.187 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 120 | 0.01 score on a scale | Standard Deviation 0.166 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 240 | -0.01 score on a scale | Standard Deviation 0.154 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Baseline 303 | 0.77 score on a scale | Standard Deviation 0.233 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Baseline 303 | 0.79 score on a scale | Standard Deviation 0.201 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 24 | 0.00 score on a scale | Standard Deviation 0.144 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 48 | -0.01 score on a scale | Standard Deviation 0.152 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 12 | -0.01 score on a scale | Standard Deviation 0.137 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 96 | -0.02 score on a scale | Standard Deviation 0.17 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 120 | -0.01 score on a scale | Standard Deviation 0.175 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 144 | -0.02 score on a scale | Standard Deviation 0.172 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 192 | -0.03 score on a scale | Standard Deviation 0.174 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 240 | -0.06 score on a scale | Standard Deviation 0.187 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Baseline 303 | 0.71 score on a scale | Standard Deviation 0.242 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 48 | 0.00 score on a scale | Standard Deviation 0.164 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 96 | -0.01 score on a scale | Standard Deviation 0.162 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 48 | 0.00 score on a scale | Standard Deviation 0.174 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Baseline 303 | 0.77 score on a scale | Standard Deviation 0.213 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, 5 Dimensions (EQ 5D) Health Scores in the 205MS303 Treatment Period | Change to Week 96 | 0.00 score on a scale | Standard Deviation 0.184 |
Secondary
Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period
The participant rated their current heath state using the EQ VAS 20-centimeter horizontal line from 0 (worst imaginable health state) to 100 (best imaginable health state). A positive change from baseline indicates improvement.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 96, 120, 44, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48 and 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 12 | 1.42 score on a scale | Standard Deviation 12.753 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 24 | 1.20 score on a scale | Standard Deviation 12.135 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Baseline 303 | 76.19 score on a scale | Standard Deviation 19.534 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 120 | 0.80 score on a scale | Standard Deviation 13.406 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 96 | -0.54 score on a scale | Standard Deviation 14.963 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 48 | 0.66 score on a scale | Standard Deviation 12.966 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 192 | 0.45 score on a scale | Standard Deviation 15.058 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 144 | 0.36 score on a scale | Standard Deviation 14.263 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 240 | -0.64 score on a scale | Standard Deviation 11.318 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 240 | -1.53 score on a scale | Standard Deviation 13.082 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 24 | 0.74 score on a scale | Standard Deviation 11.4 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Baseline 303 | 77.74 score on a scale | Standard Deviation 19.144 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 12 | 0.25 score on a scale | Standard Deviation 12.358 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 48 | -0.35 score on a scale | Standard Deviation 13.543 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 96 | 0.56 score on a scale | Standard Deviation 12.054 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 120 | 1.52 score on a scale | Standard Deviation 13.492 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 144 | 1.64 score on a scale | Standard Deviation 13.648 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 192 | 0.66 score on a scale | Standard Deviation 14.921 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 96 | 0.45 score on a scale | Standard Deviation 11.724 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 48 | -1.50 score on a scale | Standard Deviation 13.604 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Baseline 303 | 72.13 score on a scale | Standard Deviation 21.154 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 96 | -0.95 score on a scale | Standard Deviation 11.222 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Baseline 303 | 76.97 score on a scale | Standard Deviation 19.225 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in Quality of Life as Assessed by the European Quality of Life, Visual Analog Scale (EQ VAS) in the 205MS303 Treatment Period | Change at Week 48 | -0.64 score on a scale | Standard Deviation 13.44 |
Secondary
Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period
The EDSS measures the disability status of people with multiple sclerosis as assessed by the Study Neurologist based on 8 functional systems that ranges from 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. Higher scores indicate more disability. A negative change from Baseline indicates improvement.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 260; 203-303 and 302-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 116 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 192 | 0.22 score on a scale | Standard Deviation 0.756 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 120 | 0.17 score on a scale | Standard Deviation 0.768 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 144 | 0.16 score on a scale | Standard Deviation 0.742 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 168 | 0.22 score on a scale | Standard Deviation 0.798 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Baseline 303 | 2.50 score on a scale | Standard Deviation 1.468 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 260 | 0.53 score on a scale | Standard Deviation 1.007 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 24 | 0.06 score on a scale | Standard Deviation 0.57 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 48 | 0.09 score on a scale | Standard Deviation 0.614 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 240 | 0.19 score on a scale | Standard Deviation 0.789 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 72 | 0.11 score on a scale | Standard Deviation 0.67 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 216 | 0.22 score on a scale | Standard Deviation 0.775 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 96 | 0.13 score on a scale | Standard Deviation 0.729 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 12 | 0.04 score on a scale | Standard Deviation 0.464 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 240 | 0.26 score on a scale | Standard Deviation 0.829 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 260 | -0.17 score on a scale | Standard Deviation 0.718 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 120 | 0.11 score on a scale | Standard Deviation 0.578 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 48 | 0.06 score on a scale | Standard Deviation 0.495 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 144 | 0.17 score on a scale | Standard Deviation 0.701 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 216 | 0.22 score on a scale | Standard Deviation 0.762 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 168 | 0.19 score on a scale | Standard Deviation 0.765 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 12 | 0.02 score on a scale | Standard Deviation 0.467 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 192 | 0.22 score on a scale | Standard Deviation 0.777 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 96 | 0.13 score on a scale | Standard Deviation 0.602 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 72 | 0.10 score on a scale | Standard Deviation 0.548 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 24 | 0.03 score on a scale | Standard Deviation 0.48 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Baseline 303 | 2.44 score on a scale | Standard Deviation 1.409 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 72 | 0.04 score on a scale | Standard Deviation 0.378 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Baseline 303 | 2.86 score on a scale | Standard Deviation 1.5 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 12 | 0.14 score on a scale | Standard Deviation 0.244 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 24 | 0.02 score on a scale | Standard Deviation 0.237 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 48 | 0.00 score on a scale | Standard Deviation 0.349 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 96 | 0.04 score on a scale | Standard Deviation 0.4 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 116 | 0.05 score on a scale | Standard Deviation 0.353 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 116 | 0.11 score on a scale | Standard Deviation 0.572 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 96 | 0.01 score on a scale | Standard Deviation 0.486 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 72 | 0.00 score on a scale | Standard Deviation 0.542 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 48 | -0.05 score on a scale | Standard Deviation 0.455 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 24 | -0.06 score on a scale | Standard Deviation 0.325 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Change at Week 12 | 0.00 score on a scale | Standard Deviation 0 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Change From Baseline in the Expanded Disability Status Scale (EDSS) Score in the 205MS303 Treatment Period | Baseline 303 | 2.56 score on a scale | Standard Deviation 1.395 |
Secondary
Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period
MSFC is a three-part, standardized, quantitative, assessment instrument consisting of (Timed 25-Foot Walk, Nine-Hole Peg Test (9HPT) and Paced Auditory Serial Addition Test (PASAT-3). 2 timed 25-foot walk scores are averaged. 4 trials of the Peg Test (2 for each hand) are converted to the reciprocals and averaged. The number correct of the PASAT-3 is used. The composite Z-score is calculated by: Z(25-foot walk) + Z (HPT) + Z(PASAT)/3. A positive change from baseline indicates improvement.
Time frame: Baseline 303, Weeks 12, 24 and 48 in Study 303
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Change to Week 48 | -0.01026 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Baseline 303 | 0.24958 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Change to Week 24 | -0.00599 z-score |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Change to Week 12 | 0.00010 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Change to Week 48 | -0.01897 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Change to Week 24 | -0.00010 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Baseline 303 | 0.30019 z-score |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Functional Composite (MSFC) Score in the 205MS303 Treatment Period | Change to Week 12 | -0.01021 z-score |
Comparison: Change to Week 12p-value: 0.5937ANCOVA
Comparison: Change to Week 24p-value: 0.6233ANCOVA
Comparison: Change to Week 48p-value: 0.1884ANCOVA
Secondary
Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period
The 29-item MSIS-29 is a disease specific participant-reported outcome measure that has been developed and validated to examine the physical (coordination and mobility) and psychological (mental) impact of MS from a participant's perspective; it measures 20 physical items and 9 psychological items. The results for each of the physical and psychological scores are transformed to a score of 0 to 100 (worse state of health). A negative change from Baseline indicates improvement.
Time frame: Baseline 303, Weeks 12, 24, 48, 96, 120 and 144
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 144 | -1.25 score on a scale | Standard Deviation 0 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Baseline 303 | 23.46 score on a scale | Standard Deviation 21.31 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 48 | 0.12 score on a scale | Standard Deviation 11.178 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 12 | -1.06 score on a scale | Standard Deviation 12.501 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Baseline 303 | 20.61 score on a scale | Standard Deviation 20.134 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 24 | -1.14 score on a scale | Standard Deviation 14.154 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 96 | 2.23 score on a scale | Standard Deviation 12.713 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 48 | -0.46 score on a scale | Standard Deviation 14.865 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 24 | -0.46 score on a scale | Standard Deviation 10.313 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 96 | -0.16 score on a scale | Standard Deviation 13.923 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 120 | 0.51 score on a scale | Standard Deviation 9.062 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 120 | -2.26 score on a scale | Standard Deviation 10.105 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 144 | 8.33 score on a scale | Standard Deviation 0 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 12 | 0.22 score on a scale | Standard Deviation 11.114 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 144 | -13.89 score on a scale | Standard Deviation 0 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 120 | 0.00 score on a scale | Standard Deviation 8.642 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Baseline 303 | 19.19 score on a scale | Standard Deviation 19.39 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 12 | -0.28 score on a scale | Standard Deviation 9.217 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 24 | -0.88 score on a scale | Standard Deviation 9.147 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 48 | 0.13 score on a scale | Standard Deviation 9.779 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 96 | 0.48 score on a scale | Standard Deviation 10.617 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 120 | 1.44 score on a scale | Standard Deviation 10.504 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Baseline 303 | 22.37 score on a scale | Standard Deviation 20.816 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 12 | -0.34 score on a scale | Standard Deviation 11.226 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 24 | -1.69 score on a scale | Standard Deviation 11.576 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 48 | 0.10 score on a scale | Standard Deviation 13.648 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Psychological Scores: Change to Week 96 | -0.89 score on a scale | Standard Deviation 14.411 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Change From Baseline in the Multiple Sclerosis Impact Scale 29 (MSIS 29) Physical and Psychological Scores in the 205MS303 Treatment Period | Physical Scores: Change to Week 144 | -5.00 score on a scale | Standard Deviation 0 |
Secondary
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period
Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.
Time frame: Baseline 301, Weeks 24, 48, 72, 96, 120 and 144 in 301
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 24 | 76 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Baseline 301 | 93 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 48 | 65 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 24 | 50 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 48 | 77 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Baseline 301 | 277 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 72 | 54 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 72 | 60 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 96 | 44 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 120 | 55 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 120 | 43 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 96 | 88 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 144 | 24 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 144 | 13 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 144 | 32 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 96 | 53 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Baseline 301 | 349 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 24 | 78 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 48 | 49 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 120 | 18 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 144 | 24 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Baseline 301 | 93 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 24 | 45 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 48 | 51 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 72 | 69 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 96 | 52 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | Non MS-related Site Visits: Week 120 | 41 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS301 Treatment Period | MS-related Site Visits: Week 72 | 49 site visits |
Secondary
Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period
Heath resource utilization was assessed by the number of hospitalizations, emergency room visits, and unscheduled neurologist visits for MS-related and non-MS-related visits.
Time frame: 301-303: Baseline 303, Weeks 24, 48, 96, 144, 192, 240; 203-303 and 302-303: Baseline 303, Weeks 48, 96 in 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 24 | 81 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 48 | 111 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Baseline 303 | 141 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 24 | 80 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 48 | 100 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 96 | 46 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 144 | 37 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 192 | 26 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 240 | 6 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Baseline 303 | 90 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 96 | 90 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 144 | 52 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 192 | 42 site visits |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 240 | 10 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 48 | 70 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 96 | 71 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 144 | 36 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 192 | 26 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 192 | 39 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 240 | 16 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 144 | 42 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 24 | 56 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Baseline 303 | 97 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 48 | 41 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Baseline 303 | 102 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 24 | 48 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 240 | 12 site visits |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 96 | 93 site visits |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 96 | 20 site visits |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Baseline 303 | 27 site visits |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 48 | 16 site visits |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 96 | 23 site visits |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Baseline 303 | 15 site visits |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 48 | 15 site visits |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Baseline 303 | 2 site visits |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Baseline 303 | 11 site visits |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 96 | 3 site visits |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | MS-related Site Visits: Week 48 | 6 site visits |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 96 | 10 site visits |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Direct Health Resource Utilization (HRU): Number of Unscheduled Site Visits in the 205MS303 Treatment Period | Non-MS related Site Visits: Week 48 | 5 site visits |
Secondary
Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded their scheduled work hours. Data is reported by part time or full time employment.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 12 | 37.3 hours | Standard Deviation 14.23 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Baseline 303 | 36.8 hours | Standard Deviation 14.23 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 72 | 21.6 hours | Standard Deviation 12.44 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 216 | 37.7 hours | Standard Deviation 12.44 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 240 | 21.3 hours | Standard Deviation 8.54 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 216 | 24.9 hours | Standard Deviation 13.18 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 96 | 25.7 hours | Standard Deviation 17.4 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 144 | 22.9 hours | Standard Deviation 14.79 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 192 | 37.7 hours | Standard Deviation 10.31 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 168 | 21.0 hours | Standard Deviation 12.06 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 120 | 37.7 hours | Standard Deviation 11.04 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 192 | 23.2 hours | Standard Deviation 12.07 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 120 | 27.0 hours | Standard Deviation 16.13 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 144 | 37.3 hours | Standard Deviation 12.79 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Baseline 303 | 20.4 hours | Standard Deviation 10.6 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 24 | 21.2 hours | Standard Deviation 12.8 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 168 | 37.3 hours | Standard Deviation 12.35 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 72 | 36.9 hours | Standard Deviation 12.9 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 12 | 21.4 hours | Standard Deviation 10.3 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 96 | 36.0 hours | Standard Deviation 13.42 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 48 | 36.0 hours | Standard Deviation 13.47 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 24 | 35.0 hours | Standard Deviation 15.43 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 48 | 22.3 hours | Standard Deviation 11.12 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 240 | 39.8 hours | Standard Deviation 4.16 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 240 | 39.3 hours | Standard Deviation 12.33 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 24 | 20.6 hours | Standard Deviation 13.47 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 96 | 19.9 hours | Standard Deviation 11.79 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 120 | 20.8 hours | Standard Deviation 13.15 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 96 | 37.6 hours | Standard Deviation 12.35 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 120 | 39.2 hours | Standard Deviation 22.8 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Baseline 303 | 19.5 hours | Standard Deviation 11.45 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 12 | 22.4 hours | Standard Deviation 13.62 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 48 | 21.9 hours | Standard Deviation 11.28 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 72 | 23.0 hours | Standard Deviation 11.64 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 144 | 21.4 hours | Standard Deviation 12.9 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 168 | 20.3 hours | Standard Deviation 11.93 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 192 | 23.2 hours | Standard Deviation 16.37 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 216 | 25.3 hours | Standard Deviation 11.79 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Baseline 303 | 37.4 hours | Standard Deviation 12.71 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 12 | 38.5 hours | Standard Deviation 18.79 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 24 | 36.4 hours | Standard Deviation 17.43 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 48 | 38.2 hours | Standard Deviation 20.63 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 72 | 38.5 hours | Standard Deviation 12.21 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 144 | 39.7 hours | Standard Deviation 12.68 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 168 | 39.4 hours | Standard Deviation 10.36 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 192 | 40.4 hours | Standard Deviation 9 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 216 | 38.8 hours | Standard Deviation 11.68 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 24 | 23.5 hours | Standard Deviation 9.37 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 24 | 37.2 hours | Standard Deviation 14.19 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 72 | 22.8 hours | Standard Deviation 11.6 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 48 | 38.6 hours | Standard Deviation 10.9 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 96 | 36.4 hours | Standard Deviation 14.36 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Baseline 303 | 39.3 hours | Standard Deviation 12.23 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 72 | 38.4 hours | Standard Deviation 9.91 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 48 | 22.7 hours | Standard Deviation 11.23 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Baseline 303 | 23.6 hours | Standard Deviation 9.46 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 96 | 24.8 hours | Standard Deviation 10.13 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 24 | 24.5 hours | Standard Deviation 5.22 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 24 | 42.0 hours | Standard Deviation 7.34 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 96 | 41.5 hours | Standard Deviation 5.05 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 48 | 41.1 hours | Standard Deviation 8.5 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Baseline 303 | 20.2 hours | Standard Deviation 6.06 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 96 | 23.5 hours | Standard Deviation 7.98 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 72 | 25.2 hours | Standard Deviation 6.08 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Week 72 | 42.0 hours | Standard Deviation 5.24 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Part Time: Week 48 | 27.7 hours | Standard Deviation 13.79 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Health Related Productivity Questionnaire (HRPQ): Scheduled Work Hours in the 205MS303 Treatment Period | Full Time: Baseline 303 | 40.1 hours | Standard Deviation 10.44 |
Secondary
HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded the hours where they were not able to perform household chores due to MS or its treatments.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants unable to complete chores with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 120 | 6.0 hours | Standard Deviation 8.23 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 12 | 7.0 hours | Standard Deviation 9.35 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 72 | 7.2 hours | Standard Deviation 7.16 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 24 | 6.3 hours | Standard Deviation 7.56 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 144 | 5.7 hours | Standard Deviation 4.95 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 216 | 6.9 hours | Standard Deviation 7.09 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 96 | 5.2 hours | Standard Deviation 3.93 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 240 | 5.5 hours | Standard Deviation 6.36 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 48 | 7.3 hours | Standard Deviation 11.41 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Baseline 303 | 6.4 hours | Standard Deviation 7.82 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 192 | 6.9 hours | Standard Deviation 9.01 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 168 | 5.8 hours | Standard Deviation 5.19 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 216 | 7.3 hours | Standard Deviation 10.97 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 144 | 6.3 hours | Standard Deviation 6.1 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 240 | 9.8 hours | Standard Deviation 13.04 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Baseline 303 | 5.1 hours | Standard Deviation 5.08 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 12 | 5.9 hours | Standard Deviation 7.63 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 24 | 5.2 hours | Standard Deviation 4.59 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 48 | 4.7 hours | Standard Deviation 3.53 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 72 | 6.6 hours | Standard Deviation 10.32 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 96 | 5.1 hours | Standard Deviation 4.67 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 120 | 5.9 hours | Standard Deviation 11.13 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 168 | 5.5 hours | Standard Deviation 5.16 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 192 | 5.7 hours | Standard Deviation 5.96 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 24 | 5.7 hours | Standard Deviation 7.75 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 72 | 6.8 hours | Standard Deviation 8.03 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Baseline 303 | 5.4 hours | Standard Deviation 6.25 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 48 | 7.9 hours | Standard Deviation 9.19 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 96 | 8.1 hours | Standard Deviation 9.35 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 48 | 4.7 hours | Standard Deviation 4.21 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 96 | 3.8 hours | Standard Deviation 3.81 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Baseline 303 | 5.2 hours | Standard Deviation 4.06 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 24 | 5.0 hours | Standard Deviation 3.57 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours Not Performing Household Chores Due to MS or Its Treatment in 205MS303 Treatment Period | Week 72 | 5.8 hours | Standard Deviation 4.46 |
Secondary
HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded their planned hours for household chores.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 24 | 12.0 hours | Standard Deviation 11.75 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 120 | 12.6 hours | Standard Deviation 12.09 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 144 | 13.0 hours | Standard Deviation 12.89 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 168 | 12.9 hours | Standard Deviation 12.35 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Baseline 303 | 10.1 hours | Standard Deviation 10.87 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 12 | 11.8 hours | Standard Deviation 11.38 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 48 | 11.6 hours | Standard Deviation 11.43 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 72 | 13.3 hours | Standard Deviation 12.1 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 96 | 11.9 hours | Standard Deviation 10.7 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 192 | 13.4 hours | Standard Deviation 11.78 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 216 | 14.2 hours | Standard Deviation 13.01 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 240 | 13.6 hours | Standard Deviation 11.49 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Baseline 303 | 10.0 hours | Standard Deviation 10.85 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 216 | 14.0 hours | Standard Deviation 11.46 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 48 | 12.6 hours | Standard Deviation 11.39 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 192 | 13.9 hours | Standard Deviation 12.43 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 72 | 13.9 hours | Standard Deviation 12.87 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 24 | 12.6 hours | Standard Deviation 11.24 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 120 | 13.1 hours | Standard Deviation 12.09 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 240 | 10.1 hours | Standard Deviation 7.89 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 144 | 13.4 hours | Standard Deviation 11.99 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 96 | 13.5 hours | Standard Deviation 12.1 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 168 | 13.7 hours | Standard Deviation 12.58 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 12 | 12.2 hours | Standard Deviation 12.33 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 48 | 15.7 hours | Standard Deviation 14.74 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 24 | 14.4 hours | Standard Deviation 13.66 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 96 | 14.8 hours | Standard Deviation 12.2 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Baseline 303 | 15.8 hours | Standard Deviation 13.68 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 72 | 15.0 hours | Standard Deviation 13.55 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 72 | 12.3 hours | Standard Deviation 8.94 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 96 | 12.6 hours | Standard Deviation 9.17 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 24 | 11.1 hours | Standard Deviation 7.72 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Baseline 303 | 11.5 hours | Standard Deviation 7.94 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Household Chores Planned to Perform in the 205MS303 Treatment Period | Week 48 | 11.6 hours | Standard Deviation 8.37 |
Secondary
HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded the hours they missed work due to MS or its treatments. Data is reported by part time or full time employment.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants who missed work with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 11.0 hours | Standard Deviation 11.42 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 72 | 7.5 hours | Standard Deviation 7.01 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 120 | 9.5 hours | Standard Deviation 5.92 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 240 | 5.0 hours | Standard Deviation 0 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 216 | 3.0 hours | Standard Deviation 0 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 96 | 22.2 hours | Standard Deviation 38.48 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 144 | 16.0 hours | Standard Deviation 14.32 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 144 | 3.3 hours | Standard Deviation 2.22 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 120 | 12.4 hours | Standard Deviation 13.88 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 168 | 7.3 hours | Standard Deviation 7.9 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 192 | 3.6 hours | Standard Deviation 1.14 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 72 | 13.8 hours | Standard Deviation 11.51 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 216 | 10.3 hours | Standard Deviation 13.98 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 96 | 14.2 hours | Standard Deviation 13.19 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 12 | 8.7 hours | Standard Deviation 8.43 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 24 | 15.2 hours | Standard Deviation 19.31 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 8.5 hours | Standard Deviation 5.82 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 48 | 15.7 hours | Standard Deviation 15.5 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 192 | 15.9 hours | Standard Deviation 11.94 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 24 | 11.2 hours | Standard Deviation 13.8 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 48 | 8.6 hours | Standard Deviation 4.85 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 168 | 7.3 hours | Standard Deviation 4.45 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 12 | 8.5 hours | Standard Deviation 10.13 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 240 | 14.5 hours | Standard Deviation 4.95 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 5.6 hours | Standard Deviation 4.93 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 96 | 8.7 hours | Standard Deviation 12.02 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 72 | 7.6 hours | Standard Deviation 6 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 12 | 8.4 hours | Standard Deviation 8.11 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 24 | 10.1 hours | Standard Deviation 3.63 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 168 | 5.3 hours | Standard Deviation 5.16 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 48 | 12.3 hours | Standard Deviation 12.83 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 72 | 10.1 hours | Standard Deviation 13.05 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 120 | 7.3 hours | Standard Deviation 8.21 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 144 | 10.3 hours | Standard Deviation 7.18 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 192 | 9.0 hours | Standard Deviation 4.24 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 216 | 16.4 hours | Standard Deviation 15.71 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 15.0 hours | Standard Deviation 13.58 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 12 | 7.9 hours | Standard Deviation 8.06 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 24 | 12.4 hours | Standard Deviation 13.31 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 48 | 11.7 hours | Standard Deviation 11.11 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 96 | 16.1 hours | Standard Deviation 15.14 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 120 | 10.7 hours | Standard Deviation 11.19 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 144 | 13.1 hours | Standard Deviation 15.44 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 168 | 16.9 hours | Standard Deviation 15.73 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 192 | 10.0 hours | Standard Deviation 11.53 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 216 | 11.2 hours | Standard Deviation 14 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 24 | 14.1 hours | Standard Deviation 16.27 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 24 | 8.3 hours | Standard Deviation 6.51 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 72 | 15.0 hours | Standard Deviation 17.54 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 96 | 6.7 hours | Standard Deviation 2.89 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 72 | 16.0 hours | Standard Deviation 19.8 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 96 | 5.0 hours | Standard Deviation 0 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 8.8 hours | Standard Deviation 11.39 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 48 | 4.5 hours | Standard Deviation 3.54 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 48 | 12.7 hours | Standard Deviation 15.57 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 12.0 hours | Standard Deviation 0 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 48 | 6.7 hours | Standard Deviation 3.06 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 24 | 7.3 hours | Standard Deviation 1.15 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 24 | 3.0 hours | Standard Deviation 1.41 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 96 | 22.5 hours | Standard Deviation 3.54 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 72 | 8.7 hours | Standard Deviation 3.06 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 48 | 15.0 hours | Standard Deviation 0 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 20.0 hours | Standard Deviation 0 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 8.0 hours | Standard Deviation 0 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Full Time: Week 96 | 3.0 hours | — |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Hours of Work Missed Due to MS or Its Treatment in the 205MS303 Treatment Period | Part Time: Week 72 | 7.0 hours | Standard Deviation 4.24 |
Secondary
HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant recorded whether MS or its treatments kept them from completing household chores.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 144 | 91 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 168 | 82 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 216 | 65 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 240 | 2 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Baseline 303 | 112 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 72 | 111 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 12 | 110 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 24 | 125 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 48 | 113 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 192 | 71 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 96 | 94 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 120 | 93 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 192 | 65 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 12 | 111 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 96 | 79 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 24 | 110 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 240 | 7 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 48 | 93 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 216 | 65 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Baseline 303 | 104 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 120 | 84 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 72 | 93 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 144 | 87 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 168 | 81 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 24 | 68 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 48 | 66 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 72 | 58 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 96 | 53 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Baseline 303 | 58 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 24 | 12 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Baseline 303 | 15 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 48 | 19 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 72 | 15 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Kept the Participant From Completing Chores in the 205MS303 Treatment Period | Week 96 | 16 Participants |
Secondary
HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participant recorded whether their MS or its treatments caused them to miss work. Data is reported by part time or full time employment.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 48 | 9 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 192 | 10 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 72 | 7 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 168 | 5 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 12 | 19 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Baseline 303 | 28 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 96 | 6 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 216 | 6 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 240 | 1 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 216 | 1 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 120 | 11 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 12 | 10 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 144 | 4 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 240 | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 192 | 5 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 144 | 16 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Baseline 303 | 11 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 120 | 8 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 72 | 13 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 168 | 10 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 24 | 12 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 96 | 10 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 48 | 20 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 24 | 11 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 120 | 18 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 168 | 6 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 144 | 16 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 168 | 17 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 192 | 13 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 216 | 10 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 240 | 2 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Baseline 303 | 7 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 12 | 8 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 24 | 7 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 48 | 7 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 72 | 4 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 96 | 5 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 120 | 6 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 144 | 6 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 192 | 3 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 216 | 4 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Baseline 303 | 30 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 12 | 26 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 24 | 21 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 48 | 24 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 72 | 10 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 96 | 16 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 72 | 2 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 96 | 3 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 24 | 8 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 24 | 3 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 48 | 6 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Baseline 303 | 1 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 48 | 2 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 72 | 6 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 96 | 2 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Baseline 303 | 11 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Baseline 303 | 3 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Baseline 303 | 1 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 24 | 2 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 72 | 2 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 48 | 1 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 24 | 3 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Part Time: Week 96 | 2 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 96 | 1 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 72 | 3 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Number of Participants Where MS or Its Treatments Resulted in Missed Work in the 205MS303 Treatment Period | Full Time: Week 48 | 3 Participants |
Secondary
HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on employment. The participants assessed the percent impact of MS and its treatments on their work output using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything. Data is reported for part time or full time employment.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 120 | 19.6 percent impact | Standard Deviation 26.58 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 168 | 8.8 percent impact | Standard Deviation 18.53 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 216 | 10.0 percent impact | Standard Deviation 22.36 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 12 | 8.0 percent impact | Standard Deviation 17.72 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 240 | 13.1 percent impact | Standard Deviation 23.33 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 168 | 35.7 percent impact | Standard Deviation 33.82 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 12 | 18.8 percent impact | Standard Deviation 24.06 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 96 | 18.4 percent impact | Standard Deviation 24.01 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 18.4 percent impact | Standard Deviation 24.18 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 24 | 9.1 percent impact | Standard Deviation 20.13 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 72 | 20.8 percent impact | Standard Deviation 27.63 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 48 | 16.0 percent impact | Standard Deviation 23.54 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 10.0 percent impact | Standard Deviation 19.52 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 120 | 6.4 percent impact | Standard Deviation 13.87 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 48 | 8.2 percent impact | Standard Deviation 19.37 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 24 | 17.5 percent impact | Standard Deviation 24.3 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 240 | 7.5 percent impact | Standard Deviation 15 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 216 | 23.6 percent impact | Standard Deviation 27.73 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 72 | 9.7 percent impact | Standard Deviation 21.4 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 192 | 9.0 percent impact | Standard Deviation 19.23 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 192 | 30.9 percent impact | Standard Deviation 33.29 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 144 | 17.4 percent impact | Standard Deviation 23.16 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 96 | 7.3 percent impact | Standard Deviation 18.29 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 144 | 8.2 percent impact | Standard Deviation 18.36 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 192 | 7.5 percent impact | Standard Deviation 17.59 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 24 | 16.8 percent impact | Standard Deviation 22.84 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 120 | 22.4 percent impact | Standard Deviation 30.15 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 11.8 percent impact | Standard Deviation 24.02 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 12 | 10.3 percent impact | Standard Deviation 21.17 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 24 | 8.3 percent impact | Standard Deviation 18.54 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 48 | 9.6 percent impact | Standard Deviation 21.75 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 72 | 7.8 percent impact | Standard Deviation 18.39 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 96 | 8.4 percent impact | Standard Deviation 18.59 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 216 | 9.3 percent impact | Standard Deviation 20.91 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 240 | 7.5 percent impact | Standard Deviation 18.01 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 21.1 percent impact | Standard Deviation 26.16 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 48 | 14.0 percent impact | Standard Deviation 23.03 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 72 | 18.8 percent impact | Standard Deviation 27.93 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 96 | 16.8 percent impact | Standard Deviation 23.9 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 144 | 15.3 percent impact | Standard Deviation 24.07 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 168 | 15.3 percent impact | Standard Deviation 22.93 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 192 | 21.4 percent impact | Standard Deviation 25.03 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 216 | 20.3 percent impact | Standard Deviation 28.78 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 120 | 8.6 percent impact | Standard Deviation 19.19 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 144 | 7.8 percent impact | Standard Deviation 17.91 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 168 | 10.1 percent impact | Standard Deviation 22.45 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 12 | 16.0 percent impact | Standard Deviation 22.87 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 96 | 19.1 percent impact | Standard Deviation 23.8 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 96 | 11.1 percent impact | Standard Deviation 23.76 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 72 | 14.0 percent impact | Standard Deviation 23.47 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 13.9 percent impact | Standard Deviation 25.56 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 48 | 18.8 percent impact | Standard Deviation 25.03 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 19.0 percent impact | Standard Deviation 24.78 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 48 | 12.2 percent impact | Standard Deviation 23.87 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 72 | 23.3 percent impact | Standard Deviation 29.5 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 24 | 26.5 percent impact | Standard Deviation 33.85 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 24 | 12.7 percent impact | Standard Deviation 25.79 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Baseline 303 | 32.2 percent impact | Standard Deviation 34.65 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 96 | 22.3 percent impact | Standard Deviation 33.41 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Baseline 303 | 6.7 percent impact | Standard Deviation 16.33 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 72 | 11.3 percent impact | Standard Deviation 22.72 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 96 | 10.2 percent impact | Standard Deviation 24.63 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 24 | 11.2 percent impact | Standard Deviation 25.2 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 72 | 11.1 percent impact | Standard Deviation 10.83 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 48 | 19.1 percent impact | Standard Deviation 24.17 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Full Time: Week 48 | 9.9 percent impact | Standard Deviation 24.25 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Employment in the 205MS303 Treatment Period | Part Time: Week 24 | 14.4 percent impact | Standard Deviation 14.42 |
Secondary
HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period
The HRPQ was used by the participant to assess the impact of MS or its treatments on performing household chores. The participant assessed the percent impact of MS and its treatments on how much they accomplished using a VAS where 0= MS or its treatments had no impact on how much I accomplished to 100=MS or its treatments kept me from accomplishing anything.
Time frame: 301-303: Baseline 303, Weeks 12, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240; 203-303 and 302-303: Baseline 303, Weeks 24, 48, 72, 96 in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Baseline 303 | 16.0 percent impact | Standard Deviation 23.16 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 144 | 16.5 percent impact | Standard Deviation 24.4 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 120 | 17.4 percent impact | Standard Deviation 25.1 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 72 | 19.9 percent impact | Standard Deviation 26.83 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 240 | 9.6 percent impact | Standard Deviation 14.95 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 96 | 16.4 percent impact | Standard Deviation 25.39 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 216 | 18.8 percent impact | Standard Deviation 26.11 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 192 | 18.5 percent impact | Standard Deviation 26.55 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 12 | 16.7 percent impact | Standard Deviation 24.4 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 24 | 17.0 percent impact | Standard Deviation 25.23 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 168 | 19.1 percent impact | Standard Deviation 26.03 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 48 | 16.9 percent impact | Standard Deviation 25.48 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 240 | 16.0 percent impact | Standard Deviation 26.06 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 12 | 17.5 percent impact | Standard Deviation 25.38 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Baseline 303 | 17.5 percent impact | Standard Deviation 25.31 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 24 | 16.7 percent impact | Standard Deviation 24.71 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 48 | 17.1 percent impact | Standard Deviation 26.23 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 72 | 17.8 percent impact | Standard Deviation 26.13 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 96 | 17.7 percent impact | Standard Deviation 26.18 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 120 | 16.9 percent impact | Standard Deviation 25 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 144 | 17.4 percent impact | Standard Deviation 25.25 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 168 | 18.2 percent impact | Standard Deviation 26.37 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 192 | 17.3 percent impact | Standard Deviation 25.07 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 216 | 18.3 percent impact | Standard Deviation 26.18 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 48 | 23.8 percent impact | Standard Deviation 28.52 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Baseline 303 | 25.3 percent impact | Standard Deviation 29.42 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 24 | 25.5 percent impact | Standard Deviation 28.81 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 96 | 23.8 percent impact | Standard Deviation 29.07 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 72 | 25.4 percent impact | Standard Deviation 27.88 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Baseline 303 | 18.9 percent impact | Standard Deviation 24.41 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 48 | 21.0 percent impact | Standard Deviation 27.62 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 96 | 21.4 percent impact | Standard Deviation 27.23 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 24 | 24.8 percent impact | Standard Deviation 30.25 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | HRPQ: Percent Impact on Performing Household Chores in the 205MS303 Treatment Period | Week 72 | 19.6 percent impact | Standard Deviation 23.37 |
Secondary
Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS
The VAS is a 10 cm-long horizontal line labeled with 2 extremes of pain at either end: 0 =no pain on the left and 100=very painful on the right. The participant rates their perceived pain of each injection by placing a vertical mark on the line to indicate the level of pain.
Time frame: After the first and fourth injections in 303, approximately Week 0 and Week 12
Population: Safety Population consisted of all participants who completed Study 301,203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS | Fourth Injection, Post-dose | 1.6 score on scale | Standard Deviation 2.34 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Local Tolerability as Assessed by Participant-reported Injection Site Pain VAS | First Injection, Post-dose | 1.7 score on scale | Standard Deviation 2.46 |
Secondary
Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories
The investigator assessed the injection site after the first dose and before the fourth dose for the presence of erythema (None, Mild, Moderate, Severe), pigmentation (None, Hypo, Hyper), Induration (None, Mild, Moderate, Severe), Tenderness (None, Mild, Moderate, Severe) and Temperature (Normal, Warm, Hot). The number of participants in each grade is reported.
Time frame: After the first and fourth injections in 303, approximately Week 0 and Week 12
Population: Safety Population included all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Local tolerability of the DAC HYP injection was assessed for all participants who received DAC HYP in Study 303 with data available at the given timepoint and is independent of the treatment previously received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Erythema: Mild | 8 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Pigmentation: Hypo | 7 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Induration: None | 87 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Induration: Mild | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Erythema: None | 87 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Erythema: Moderate | 2 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Erythema: Severe | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Erythema: None | 87 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Erythema: Mild | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Erythema: Moderate | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Erythema: Severe | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Pigmentation: None | 90 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Pigmentation: Hyper | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Pigmentation: None | 87 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Pigmentation: Hypo | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Pigmentation: Hyper | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Induration: None | 89 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Induration: Mild | 4 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Induration: Moderate | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Induration: Severe | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Induration: Moderate | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Induration: Severe | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Tenderness: None | 94 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Tenderness: Mild | 3 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Tenderness: Moderate | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose, Tenderness: Severe | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Tenderness: None | 87 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Tenderness: Mild | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Tenderness: Moderate | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Tenderness: Severe | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose,Temperature: Normal | 97 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose,Temperature: Warm | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | First Injection Post-dose,Temperature: Hot | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Temperature: Normal | 87 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Temperature: Warm | 0 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants in Local Tolerability Clinician Injection Site Assessment Categories | Fourth Injection Pre-dose, Temperature: Hot | 0 Participants |
Secondary
Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period
Participants without clinical or radiological activity are defined as disease-free. Clinical activity includes assessment of relapses and of disease progression. Radiological activity includes assessments of Gd+ lesions and new or enlarging T2 lesions.
Time frame: Up to 4.6 years in Study 303
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period | 9 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants Who Are Free From Disease Activity in the 205MS303 Treatment Period | 7 Participants |
p-value: 0.841795% CI: [0.329, 2.473]Regression, Logistic
Secondary
Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period
Blood samples were collected for ADAbs and were analyzed using a laboratory test. The number of participants ADAb positive at any post-baseline timepoint is reported.
Time frame: Up to 4.6 years in the 303 Treatment Period
Population: Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number of participants analyzed is the number of participants with evaluable data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period | 113 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period | 48 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period | 0 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Binding Antibodies (ADAbs) in the 205MS303 Treatment Period | 0 Participants |
Secondary
Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period
Blood samples were collected for NAbs and were analyzed using a laboratory test. The number of participants NAb positive at any post-baseline timepoint is reported.
Time frame: Up to 4.6 years in the 303 Treatment Period
Population: Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303. Number of participants analyzed is the number of participants with evaluable data for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period | 45 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period | 21 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period | 0 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Anti-BIIB019 Neutralizing Antibodies (Nabs) in the 205MS303 Treatment Period | 0 Participants |
Secondary
Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period
Clinical Laboratory assessments included tests of hematology, blood chemistry, renal function, and thyroid function. The investigator determined if the results were clinically significant.
Time frame: Up to 4.6 years in 303
Population: Safety Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAC HYP in Study 303.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period | 0 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period | 0 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period | 0 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Assessments in the 205MS303 Treatment Period | 0 Participants |
Secondary
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period
Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.
Time frame: Baseline 301, Weeks 24, 96 and 144
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Baseline 301 | 263 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Week 144 | 49 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Week 24 | 153 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Week 96 | 172 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Baseline 301 | 265 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Week 96 | 66 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Week 24 | 119 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS301 Treatment Period | Week 144 | 20 Participants |
Secondary
Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period
Gd+ lesions were evaluated by MRI and were analyzed by a central MRI reader.
Time frame: 301-303: Baseline 303, Weeks 48, 96, 144, 192, 240; 203-303 and 302-303: Week 96
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and received at least one dose of DAY HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 192 | 25 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 240 | 1 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Baseline 303 | 180 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 48 | 89 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 96 | 43 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 144 | 43 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 192 | 29 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 144 | 42 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 96 | 23 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Baseline 303 | 77 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 48 | 46 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 240 | 7 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 96 | 8 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Gadolinium-enhancing (Gd+) Lesions in the 205MS303 Treatment Period | Week 96 | 2 Participants |
Secondary
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period
T2 Hyperintense Lesions were assessed by MRI and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported.
Time frame: Baseline 301, Weeks 24, 96, 144 in Study 301
Population: 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Week 24 | 347 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Week 96 | 435 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Week 144 | 126 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Week 24 | 314 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Week 96 | 368 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS301 Treatment Period | Week 144 | 113 Participants |
Secondary
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period
T2 Hyperintense Lesions were assessed by magnetic resonance imaging (MRI) and were analyzed by a central MRI reader. The number of participants with New or Newly Enlarging T2 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.
Time frame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
Population: 301-303 ITT population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. No data was collected for participants from the 203 and 302 studies. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 144 | 223 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 192 | 173 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 48 | 270 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 240 | 20 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 96 | 213 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 240 | 22 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 96 | 130 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 144 | 157 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 48 | 144 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 192 | 126 Participants |
Secondary
Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period
T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 301 Baseline in the 301 Treatment Period is reported .
Time frame: Baseline 301, Weeks 24, 96, 144 in Study 301
Population: 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | Week 24 | 276 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | Week 96 | 375 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | Week 144 | 111 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | Week 24 | 244 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | Week 96 | 300 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS301 Treatment Period | Week 144 | 87 Participants |
Secondary
Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period
T1 hypointense lesions were evaluated by MRI and were analyzed by a central MRI reader. The number of participants with New T1 Hyperintense Lesions relative to the 303 Baseline in the 303 Treatment Period is reported.
Time frame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
Population: 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected from participants from the 203 and 302 studies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 96 | 168 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 192 | 152 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 144 | 184 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 240 | 16 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 48 | 200 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 240 | 18 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 48 | 96 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 96 | 91 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 144 | 116 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With New T1 Hypointense Lesions in the 205MS303 Treatment Period | Week 192 | 94 Participants |
Secondary
Number of Participants With Relapse in the 205MS301-303 Combined Study Period
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist.
Time frame: Up to 5.6 years combining 303 with the initial Study 301
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Relapse in the 205MS301-303 Combined Study Period | 339 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Relapse in the 205MS301-303 Combined Study Period | 261 Participants |
Secondary
Number of Participants With Relapse in the 205MS303 Treatment Period
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Study Neurologist.
Time frame: Up to 4.6 years in the 303 study
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Relapse in the 205MS303 Treatment Period | 184 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Relapse in the 205MS303 Treatment Period | 172 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Relapse in the 205MS303 Treatment Period | 35 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Relapse in the 205MS303 Treatment Period | 16 Participants |
Secondary
Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period
Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 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. Higher scores indicate more disability.
Time frame: Up to 5.6 years combining 303 with the initial Study 301
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and had at least 1 dose of DAC HYP during Study 303.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | 144 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Sustained Disability Progression in the 205MS301-303 Combined Study Period | 130 Participants |
Secondary
Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period
Sustained disability progression is defined as at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from 303 baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from 303 baseline EDSS of 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. Higher scores indicate more disability.
Time frame: Up to 4.6 years in Study 303
Population: ITT Population consisted of all participants who completed Study 301, 203 or 302 and had at least 1 dose of DAC HYP during Study 303.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | 95 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | 97 Participants |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | 8 Participants |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Number of Participants With Sustained Disability Progression in the 205MS303 Treatment Period | 2 Participants |
Secondary
Percent Change in Brain Volume From 205MS301 Baseline
To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.
Time frame: Baseline 301, Weeks 48, 96, 144, 192, 240 in Study 303
Population: 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 96 | -1.871 percent change | Standard Deviation 1.372 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 192 | -2.403 percent change | Standard Deviation 1.6088 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 144 | -2.165 percent change | Standard Deviation 1.4596 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 240 | -2.415 percent change | Standard Deviation 1.6005 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 48 | -1.535 percent change | Standard Deviation 1.1975 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 240 | -1.922 percent change | Standard Deviation 1.2258 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 48 | -1.409 percent change | Standard Deviation 1.1538 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 96 | -1.595 percent change | Standard Deviation 1.0736 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 144 | -1.812 percent change | Standard Deviation 1.2044 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From 205MS301 Baseline | Week 192 | -1.970 percent change | Standard Deviation 1.3439 |
Secondary
Percent Change in Brain Volume From the 205MS303 Baseline
To assess brain atrophy, total brain volume was measured by MRI and was analyzed by a central MRI reader. A negative percent change from baseline indicates improvement.
Time frame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303
Population: 301-303 ITT Population consisted of all participants who completed Study 303 and received at least one dose of DAC HYP in Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 96 | -0.713 percent change | Standard Deviation 0.7288 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 192 | -1.225 percent change | Standard Deviation 1.0139 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 144 | -1.050 percent change | Standard Deviation 0.8566 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 240 | -1.261 percent change | Standard Deviation 1.0382 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 48 | -0.451 percent change | Standard Deviation 0.5917 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 240 | -0.852 percent change | Standard Deviation 0.989 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 48 | -0.355 percent change | Standard Deviation 0.51 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 96 | -0.549 percent change | Standard Deviation 0.6126 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 144 | -0.801 percent change | Standard Deviation 0.7145 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Percent Change in Brain Volume From the 205MS303 Baseline | Week 192 | -0.967 percent change | Standard Deviation 0.8772 |
Secondary
Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period
Volume of T2 hyperintense Lesions was evaluated by MRI and was analyzed by a central MRI reader.
Time frame: Baseline 303, Weeks 48, 96, 144, 192, 240 in Study 303; 203-303 and 302-303: Week 96
Population: ITT Population included all participants who completed Study 301, 203 or 302 and received at least 1 dose of DAC HYP in Study 303. Number Analyzed is the number of participants with data available at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 96 | 11498.94 millimeters cubed (mm^3) | Standard Deviation 12769.813 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 48 | 10738.32 millimeters cubed (mm^3) | Standard Deviation 12358.857 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 192 | 12453.96 millimeters cubed (mm^3) | Standard Deviation 13643.373 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 144 | 11242.79 millimeters cubed (mm^3) | Standard Deviation 12838.06 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 240 | 9368.05 millimeters cubed (mm^3) | Standard Deviation 12428.209 |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Baseline 303 | 10357.54 millimeters cubed (mm^3) | Standard Deviation 11977.864 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 240 | 9230.78 millimeters cubed (mm^3) | Standard Deviation 11395.493 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 48 | 9524.23 millimeters cubed (mm^3) | Standard Deviation 10822.502 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 192 | 10662.66 millimeters cubed (mm^3) | Standard Deviation 11815.075 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 96 | 10018.09 millimeters cubed (mm^3) | Standard Deviation 11432.768 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 144 | 10265.04 millimeters cubed (mm^3) | Standard Deviation 11324.227 |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Baseline 303 | 9323.33 millimeters cubed (mm^3) | Standard Deviation 10777.863 |
| DAC HYP 150 mg (203) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 96 | 16116.01 millimeters cubed (mm^3) | Standard Deviation 16791.388 |
| DAC HYP 150 mg (302) /DAC HYP 150 mg (303) | Total Volume of T2 Hyperintense Lesions in the 205MS303 Treatment Period | Week 96 | 12627.51 millimeters cubed (mm^3) | Standard Deviation 14777.178 |
Secondary
Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period
Participants answered the question: How satisfied or dissatisfied are you with the ability of the medication to prevent or treat the condition? using the following scale: Dissatisfied (Extremely dissatisfied, Very dissatisfied, Dissatisfied) or Satisfied (Somewhat satisfied, Satisfied, Very Satisfied and Extremely satisfied). The number of participants in the Dissatisfied and Satisfied categories is reported.
Time frame: Baseline 303, Weeks 12, 24, 48, 72, 96, 120 in Study 303
Population: 301-303 ITT Population consisted of all participants who completed Study 301 and received at least 1 dose of DAC HYP during Study 303. Number analyzed is the number of participants with data available at the given timepoint. No data was collected for participants from the 203 and 302 studies.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 24 | 44 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 24 | 525 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 48 | 498 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 72 | 476 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Baseline 303 | 49 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 12 | 46 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 48 | 32 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 72 | 27 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 96 | 19 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 120 | 2 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Baseline 303 | 529 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 12 | 540 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 96 | 133 Participants |
| IFN β-1a 30 µg (301)/DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 120 | 25 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Baseline 303 | 561 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 24 | 27 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 12 | 543 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 72 | 22 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 24 | 532 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 96 | 136 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 48 | 472 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 96 | 9 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 72 | 450 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Baseline 303 | 31 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 120 | 1 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 12 | 41 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Satisfied: Week 120 | 23 Participants |
| DAC HYP 150 mg (301) /DAC HYP 150 mg (303) | Treatment Satisfaction as Assessed by the Participant in the 205MS303 Treatment Period | Dissatisfied: Week 48 | 35 Participants |