Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
MS, Multiple Sclerosis
Brief summary
Primary Objective is to assess the safety of extended treatment with Daclizumab High Yield Process (DAC HYP, BIIB019) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Secondary Objective is to assess the long-term immunogenicity of DAC HYP and to assess the durability of response to DAC HYP in preventing multiple sclerosis (MS) relapse, slowing disability progression, and reducing new MS lesion formation in this study population.
Detailed description
This study will provide participants who complete Study 205MS202 (NCT00870740) with the option to receive continued open-label Daclizumab High Yield Process (DAC HYP) monotherapy and to evaluate the long-term safety, efficacy, and immunogenicity of DAC HYP monotherapy in participants with relapsing remitting multiple sclerosis (RRMS). Approximately 60 to 100 participants will be enrolled into an optional open-label, 16-week autoinjector substudy at a selected subset of sites which will run concurrently during the main study, and will evaluate the systemic exposure and local tolerability of subcutaneous administration of DAC HYP by autoinjector. The 2013-2014 trivalent influenza vaccine will be offered to all eligible participants as an optional substudy to assess the effect of DAC-HYP treatment on the immune response to vaccination,
Interventions
BIOLOGICALBIIB019 (Daclizumab)
Administered as specified in the treatment arm.
BIOLOGICALtrivalent seasonal influenza vaccine
All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site
Sponsors
AbbVie
Biogen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Main Study Eligibility: Key Inclusion Criteria: * Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. * Subjects who have completed 52 weeks in Study 205MS202 (NCT00870740) and were compliant with the 205MS202 protocol in the opinion of the Investigator. * 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
* Subjects with any significant change in their medical status from the previous study that would prelude administration of Daclizumab High Yield Process (DAC HYP) as determined by the Investigator including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in the 205MS201 (NCT00390221) or 205MS202 (NCT00870740) studies. The Investigator must re-review the subject's medical fitness for participation and must consider any diseases that would preclude treatment. * Any subject who has permanently discontinued study treatment in Study 205MS202 (NCT00870740) due to an adverse event. * Current enrollment in any investigational drug study other than Study 205MS202 (NCT00870740). * Ongoing treatment with any approved or experimental disease-modifying treatment for multiple sclerosis. * For subjects currently taking valproic acid, carbamazepine, lamotrigine, or phenytoin: * Subjects treated with any of these agents for fewer than 6 months prior to study entry are excluded from study participation unless they discontinue the agent(s) prior to study entry. * Subjects treated with 2 or more of these agents for more than 6 months prior to study entry are excluded from study participation unless they reduce to ≤1 agent prior to study entry. * Subjects who have had dose escalations of one of these agents within the 6 months prior to study entry are excluded from study participation unless they revert to a previous dose that had been used for at least 6 months prior to study entry or unless they discontinue the agent prior to study entry * Subjects who are currently receiving treatment with isoniazid, propylthiouracil, or nimesulide at the time of study entry and are not able to discontinue the agent or change to an alternative medication allowed by the protocol. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs | Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks) | An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. 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. |
| Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Annual Change in Number of T1 Hypointense Lesions | From Baseline through 288 weeks | — |
| Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | From Baseline through 288 weeks | New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader. |
| Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | From Baseline through 288 weeks | New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader. |
| Annual Change in Volume of T1 Hypointense Lesions | From Baseline through 288 weeks | Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader. |
| Percent Change in Total Brain Volume | From Baseline through 288 weeks | To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader. |
| Number of Participants With Antibodies to DAC HYP | Up to Week 288 | — |
| Annualized Relapse Rate (ARR) | Week 288 | Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The 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. Adjusted ARR was reported. |
| Annual Change in Volume of New Gadolinium-Enhancing Lesions | From Baseline through 288 weeks | — |
| Number of Participants With Sustained Disability Progression for 24 Weeks | Week 48 up to Week 288 | Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS \<1.0 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, with higher scores indicating more disability. |
| Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose | — |
| Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4 | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose | — |
| Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4 | Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose | — |
| Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose | 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. |
| Summary of Injection Site Assessment Performed by Clinician | First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose | Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported. Here, Injection=Inj, post-dose=PD |
| Number of Participants With Sustained Disability Progression for 12 Weeks | Week 48 up to Week 288 | Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS \<1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability. |
| Number of Participants With Total Number of New Gadolinium-enhancing Lesions | From Baseline through 288 weeks | New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader. |
Countries
Czechia, Germany, Hungary, India, Poland, Russia, Ukraine, United Kingdom
Participant flow
Recruitment details
Out of 410 enrolled participants, 60 participants who received at least 6 consecutive monthly doses of DAC HYP in this study and had provided written informed consent were enrolled in to the autoinjector substudy and 91 participants who received seasonal trivalent influenza vaccine were enrolled in vaccine substudy (exploratory analyses).
Participants by arm
| Arm | Count |
|---|---|
| BIIB019 Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 276. | 410 |
| Total | 410 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 88 |
| Overall Study | Consent Withdrawn | 54 |
| Overall Study | Investigator Decision | 6 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Reason not Specified | 12 |
| Overall Study | Subject non-compliance | 7 |
Baseline characteristics
| Characteristic | BIIB019 |
|---|---|
| Age, Continuous | 38.4 years STANDARD_DEVIATION 8.74 |
| Sex: Female, Male Female | 254 Participants |
| Sex: Female, Male Male | 156 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 296 / 410 |
| serious Total, serious adverse events | 148 / 410 |
Outcome results
Primary
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab
Time frame: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Population: Pharmacokinetic analysis population included all participants in the Autoinjector Substudy with a sufficient number of samples available for analysis by randomized treatment group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIIB019 | Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab | 610.5 hr*mg/mL | Standard Deviation 253.89 |
| BIIB019 (Autoinjector [AI]) | Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab | 666.8 hr*mg/mL | Standard Deviation 253.19 |
Primary
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. 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: Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks)
Population: Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIIB019 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs | Number of participants with an AEs | 358 Participants |
| BIIB019 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs | Number of participants with SAEs | 148 Participants |
| BIIB019 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs | Participants discontinuing treatment due to AE | 91 Participants |
| BIIB019 | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs | Participants withdrawing from study due to AE | 90 Participants |
Secondary
Annual Change in Number of T1 Hypointense Lesions
Time frame: From Baseline through 288 weeks
Population: T1 hypointense lesions changes reflect tissue destruction. Volume of T1 hypointense lesions is deemed a more valuable assessment. Hence number of T1 hypointense lesions were not assessed and reported.
Secondary
Annual Change in Volume of New Gadolinium-Enhancing Lesions
Time frame: From Baseline through 288 weeks
Population: Gd enhancing lesion volume reflects acute inflammatory activity. The number of Gd lesions is a more valuable outcome measure. Hence the volume of Gd enhancing lesions was not assessed and reported.
Secondary
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
New or newly enlarging T2 hyperintense lesions evaluated by MRI and analyzed by a central reader.
Time frame: From Baseline through 288 weeks
Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB019 | Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Change from Baseline at Week 48 | -340.8 mm^3 | Standard Deviation 1237.64 |
| BIIB019 | Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Change from Baseline at Week 96 | -237.7 mm^3 | Standard Deviation 1382.86 |
| BIIB019 | Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Change from Baseline at Week 144 | 38.2 mm^3 | Standard Deviation 1825.06 |
| BIIB019 | Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Change from Baseline at Week 192 | -251.2 mm^3 | Standard Deviation 2326.41 |
| BIIB019 | Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Change from Baseline at Week 240 | -269.7 mm^3 | Standard Deviation 1188.82 |
| BIIB019 | Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Change from Baseline at Week 288 | 31.9 mm^3 | Standard Deviation 1008.87 |
Secondary
Annual Change in Volume of T1 Hypointense Lesions
Volume of T1 hypointense lesions was evaluated by MRI and analyzed by a central reader.
Time frame: From Baseline through 288 weeks
Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB019 | Annual Change in Volume of T1 Hypointense Lesions | Change from Baseline at Week 48 | -183.5 mm^3 | Standard Deviation 370.66 |
| BIIB019 | Annual Change in Volume of T1 Hypointense Lesions | Change from Baseline at Week 96 | -160.6 mm^3 | Standard Deviation 443.78 |
| BIIB019 | Annual Change in Volume of T1 Hypointense Lesions | Change from Baseline at Week 144 | -142.4 mm^3 | Standard Deviation 432.57 |
| BIIB019 | Annual Change in Volume of T1 Hypointense Lesions | Change from Baseline at Week 192 | -115.2 mm^3 | Standard Deviation 826.84 |
| BIIB019 | Annual Change in Volume of T1 Hypointense Lesions | Change from Baseline at Week 240 | -140.8 mm^3 | Standard Deviation 514.38 |
| BIIB019 | Annual Change in Volume of T1 Hypointense Lesions | Change from Baseline at Week 288 | -148.4 mm^3 | Standard Deviation 500.07 |
Secondary
Annualized Relapse Rate (ARR)
Relapses are defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the Examining Neurologist. The 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. Adjusted ARR was reported.
Time frame: Week 288
Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BIIB019 | Annualized Relapse Rate (ARR) | 0.124 relapses per person-year |
Secondary
Number of Participants With Antibodies to DAC HYP
Time frame: Up to Week 288
Population: Safety population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here number of participants analyzed is the participants who were evaluated for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BIIB019 | Number of Participants With Antibodies to DAC HYP | 43 Participants |
Secondary
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
New or newly enlarging T2 hyperintense lesions evaluated by magnetic resonance imaging (MRI) and analyzed by a central reader.
Time frame: From Baseline through 288 weeks
Population: Intent-to-treat (ITT) population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New or newly enlarging T2 lesions=0 | 255 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New or newly enlarging T2 lesions=1 | 39 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New or newly enlarging T2 lesions=2 | 27 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New or newly enlarging T2 lesions=3 | 12 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New or newly enlarging T2 lesions=4 | 5 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New/newly enlarging T2 lesions=5-6 | 6 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New/newly enlarging T2 lesions=7-10 | 8 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 48 New/newly enlarging T2 lesions>=11 | 11 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions=0 | 213 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions=1 | 41 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions=2 | 17 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions=3 | 17 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions=4 | 11 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions=5-6 | 6 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions=7-10 | 10 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 96 New/newly enlarging T2 lesions>=11 | 18 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions=0 | 33 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions=1 | 5 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions=2 | 1 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions=3 | 2 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions=4 | 1 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions=5-6 | 4 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions=7-10 | 1 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 144 New/newly enlarging T2 lesions>=11 | 6 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 New/newly enlarging T2 lesions=0 | 144 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 New/newly enlarging T2 lesions=1 | 30 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 New/newly enlarging T2 lesions=2 | 24 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 New/newly enlarging T2 lesions=3 | 13 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 New/newly enlarging T2 lesions=4 | 9 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 Ne/newly enlarging T2 lesions=5-6 | 11 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 New/newly enlarging T2lesions=7-10 | 11 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 192 New/newly enlarging T2 lesions>=11 | 20 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2 lesions=0 | 60 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2 lesions=1 | 10 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2 lesions=2 | 14 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2 lesions=3 | 9 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2 lesions=4 | 7 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2 lesions=5-6 | 7 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2lesions=7-10 | 3 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 240 New/newly enlarging T2 lesions>=11 | 11 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/newly enlarging T2 lesions=0 | 14 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/newly enlarging T2 lesions=1 | 1 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/newly enlarging T2 lesions=2 | 4 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/ newly enlarging T2 lesions=3 | 1 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/newly enlarging T2 lesions=4 | 0 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/newly enlarging T2 lesions=5-6 | 1 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/newly enlarging T2 lesions=7-10 | 3 Participants |
| BIIB019 | Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline | Week 288 New/newly enlarging T2 lesions>=11 | 3 Participants |
Secondary
Number of Participants With Sustained Disability Progression for 12 Weeks
Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS \<1.0 that is sustained for 12 weeks. The EDSS measures the disability status of people with multiple sclerosis on a scale that ranges from 0 to 10, with higher scores indicating more disability.
Time frame: Week 48 up to Week 288
Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIIB019 | Number of Participants With Sustained Disability Progression for 12 Weeks | Weeks 0 - 48 | 22 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 12 Weeks | Weeks 49 - 96 | 17 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 12 Weeks | Weeks 97 - 144 | 13 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 12 Weeks | Weeks 145 -192 | 7 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 12 Weeks | Week 193 - 288 | 2 Participants |
Secondary
Number of Participants With Sustained Disability Progression for 24 Weeks
Sustained disability progression defined by at least a 1.0-point increase on the Expanded Disability Status Scale (EDSS) from a baseline EDSS ≥1.0 that is sustained for 24 weeks, or at least a 1.5-point increase on the EDSS from a baseline EDSS \<1.0 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, with higher scores indicating more disability.
Time frame: Week 48 up to Week 288
Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIIB019 | Number of Participants With Sustained Disability Progression for 24 Weeks | Weeks 0 - 48 | 19 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 24 Weeks | Weeks 49 - 96 | 18 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 24 Weeks | Weeks 97 - 144 | 11 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 24 Weeks | Weeks 145 -192 | 7 Participants |
| BIIB019 | Number of Participants With Sustained Disability Progression for 24 Weeks | Week 193 - 288 | 3 Participants |
Secondary
Number of Participants With Total Number of New Gadolinium-enhancing Lesions
New Gadolinium-enhancing lesions was evaluated by MRI and analyzed by a central reader.
Time frame: From Baseline through 288 weeks
Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 192 new Gd-enhancing lesions=1 | 13 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 144 new Gd-enhancing lesions=>4 | 2 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 192 new Gd-enhancing lesions=2 | 5 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 192 new Gd-enhancing lesions=3 | 1 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 192 new Gd-enhancing lesions=>4 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 240 new Gd-enhancing lesions=1 | 5 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 240 new Gd-enhancing lesions=2 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 240 new Gd-enhancing lesions=3 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 240 new Gd-enhancing lesions=>4 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 288 new Gd-enhancing lesions=1 | 2 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 288 new Gd-enhancing lesions=2 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 288 new Gd-enhancing lesions=3 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 288 new Gd-enhancing lesions=>4 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 48 new Gd-enhancing lesions=1 | 22 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 48 new Gd-enhancing lesions=2 | 3 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 48 new Gd-enhancing lesions=3 | 6 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 48 new Gd-enhancing lesions=>4 | 11 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 96 new Gd-enhancing lesions=1 | 14 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 96 new Gd-enhancing lesions=2 | 7 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 96 new Gd-enhancing lesions=3 | 4 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 96 new Gd-enhancing lesions=>4 | 5 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 144 new Gd-enhancing lesions=1 | 1 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 144 new Gd-enhancing lesions=2 | 0 Participants |
| BIIB019 | Number of Participants With Total Number of New Gadolinium-enhancing Lesions | Week 144 new Gd-enhancing lesions=3 | 1 Participants |
Secondary
Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab
Time frame: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Population: Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIIB019 | Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab | 31.8 mg/mL | Standard Deviation 13.11 |
| BIIB019 (Autoinjector [AI]) | Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab | 33.6 mg/mL | Standard Deviation 14.79 |
Secondary
Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4
Time frame: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Population: Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BIIB019 | Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4 | 13.8 mg/mL | Standard Deviation 7.13 |
| BIIB019 (Autoinjector [AI]) | Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4 | 15.7 mg/mL | Standard Deviation 7.31 |
Secondary
Participant-Reported Pain Visual Analog Scale (VAS) Score
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: First injection (Day 1) and fourth injection (Day 90) 0 hour, 30 minutes, 60 minutes and 8 hours post-dose
Population: The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 0 hour post-dose | 12.7 score on a scale | Standard Deviation 17.45 |
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 30 minutes post-dose | 0.1 score on a scale | Standard Deviation 0.31 |
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 60 minutes post-dose | 0.1 score on a scale | Standard Deviation 0.25 |
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 8 hours post-dose | 0.1 score on a scale | Standard Deviation 0.25 |
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 0 hour post-dose | 14.5 score on a scale | Standard Deviation 21.7 |
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 30 minutes post-dose | 0.9 score on a scale | Standard Deviation 3.51 |
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 60 minutes post-dose | 0.0 score on a scale | Standard Deviation 0.18 |
| BIIB019 | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 8 hours post-dose | 0.1 score on a scale | Standard Deviation 0.4 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 8 hours post-dose | 0.1 score on a scale | Standard Deviation 0.31 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 0 hour post-dose | 14.5 score on a scale | Standard Deviation 19.47 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 0 hour post-dose | 15.6 score on a scale | Standard Deviation 24.7 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 30 minutes post-dose | 0.4 score on a scale | Standard Deviation 1.01 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 60 minutes post-dose | 0.1 score on a scale | Standard Deviation 0.31 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 60 minutes post-dose | 0.3 score on a scale | Standard Deviation 0.6 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | Fourth injection, 30 minutes post-dose | 1.3 score on a scale | Standard Deviation 3.42 |
| BIIB019 (Autoinjector [AI]) | Participant-Reported Pain Visual Analog Scale (VAS) Score | First injection, 8 hours post-dose | 0.2 score on a scale | Standard Deviation 0.5 |
Secondary
Percent Change in Total Brain Volume
To assess brain atrophy, total brain volume was be measured by MRI and analyzed by a central reader.
Time frame: From Baseline through 288 weeks
Population: ITT population included participants who provided informed consent and received at least 1 dose of DAC HYP during the study. Here 'n' indicates number of participants who were evaluable at specific time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BIIB019 | Percent Change in Total Brain Volume | Change from Week 0 to Week 48 | -0.4 percent change | Standard Deviation 1 |
| BIIB019 | Percent Change in Total Brain Volume | Change from Week 48 to Week 96 | -0.4 percent change | Standard Deviation 0.78 |
| BIIB019 | Percent Change in Total Brain Volume | Change from Week 96 to Week 144 | -0.2 percent change | Standard Deviation 1 |
| BIIB019 | Percent Change in Total Brain Volume | Change from Week 144 to Week 192 | -0.5 percent change | Standard Deviation 0.59 |
| BIIB019 | Percent Change in Total Brain Volume | Change from Week 192 to Week 240 | -0.2 percent change | Standard Deviation 0.83 |
| BIIB019 | Percent Change in Total Brain Volume | Change from Week 240 to Week 288 | 0.1 percent change | Standard Deviation 0.73 |
Secondary
Summary of Injection Site Assessment Performed by Clinician
Injection site assessment was performed by clinician and are defined as erythema (redness) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; pigmentation changes (skin discoloration other than redness) rated on a 3 point scale from 0-2, where 0=none, 1=hypopigmentation and 2=hyperpigmentation; induration (swelling) rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; tenderness to pressure rated on a 4 point scale ranging from 0-3, where 0=none, 1=mild, 2=moderate and 3=severe; and local temperature changes of injection sites rated on a 3 point scale where 0=normal, 1=warm and 1=hot. Only those score categories for which there was at least 1 participant are reported. Here, Injection=Inj, post-dose=PD
Time frame: First injection (Day 1) and fourth injection (Day 90) 30 minutes; 8, 24, 72, and 120 hours; and 7, 10, and 14 days post-dose
Population: The participants who were enrolled in auto-injector sub study were evaluated in this outcome measure. Here 'n' indicates number of participants who were evaluable at specific time points.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 72 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema:Ist Inj 30 min PD: Mild | 1 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema:Ist Inj 8 h PD: MIld | 0 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 24 h PD: None | 28 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 72 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 120 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 7 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 10 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 14 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 30 min PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 30 min PD: Mild | 0 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 24 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 72 h PD: None | 29 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 120 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 7 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 10 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 14 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 30 min PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 24 h PD: None | 28 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 30 min PD: None | 29 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 120 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 7 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 10 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 14 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 30 min PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 24 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 72 h PD: None | 28 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 72 h PD: Hyper- | 1 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 120 h PD: None | 29 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 120 h PD: Hyper- | 1 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 7 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 10 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 14 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 30 min PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 24 h PD: None | 28 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 72 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 120 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 7 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 10 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 14 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 30 min PD: None (n=30, 28) | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 24 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 72 h PD: None | 29 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 120 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 7 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 10 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 14 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 30 min PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 30 min PD: Mild | 0 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 24 h PD: None | 28 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 72 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 120 h PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 7 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 10 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 14 days PD: None | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 30 min PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 30 min PD: Mild | 0 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 8 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 8 h PD: Mild | 0 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 24 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 72 h PD: None | 29 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 120 h PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 7 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 10 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 14 days PD: None | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 30 min PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 8 h PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 24 h PD: Normal | 28 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 72 h PD: Normal | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 120 h PD: Normal | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 7 days PD: Normal | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj,10 days PD: Normal | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj,14 days PD: Normal | 26 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 30 min PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 8 h PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 24 h PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 72 h PD: Normal | 29 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 120 h PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 7 days PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj,10 days PD: Normal | 30 Participants |
| BIIB019 | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj,14 days PD: Normal | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 24 h PD: Normal | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 30 min PD: None | 29 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 14 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema:Ist Inj 30 min PD: Mild | 1 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 8 h PD: None | 29 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 30 min PD: None (n=30, 28) | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema:Ist Inj 8 h PD: MIld | 1 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 7 days PD: Normal | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 8 h PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 120 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 7 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 7 days PD: Normal | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 10 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: Ist Inj 14 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 120 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 30 min PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 120 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 30 min PD: Mild | 1 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj,10 days PD: Normal | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 8 h PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 7 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 7 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 10 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 120 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 72 h PD: Normal | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 7 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 4th Inj, 14 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 10 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 10 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Erythema: 4th Inj 14 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 30 min PD: None | 29 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 30 min PD: None | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj,14 days PD: Normal | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 8 h PD: None | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 30 min PD: Mild | 1 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 14 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 8 h PD: None | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 120 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj,14 days PD: Normal | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 7 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 10 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 30 min PD: Normal | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 1st Inj, 14 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 30 min PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 30 min PD: Normal | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 8 h PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 120 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 8 h PD: Normal | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 7 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 72 h PD: Hyper- | 0 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 120 h PD: Normal | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 120 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 10 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 120 h PD: Hyper- | 0 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 24 h PD: Normal | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 7 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 1st Inj, 14 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 10 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj, 8 h PD: Normal | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Pigmentation: 4th Inj, 14 days PD: None | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 30 min PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 30 min PD: None | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 72 h PD: Normal | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 8 h PD: None | 30 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 30 min PD: Mild | 1 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 24 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 4th Inj,10 days PD: Normal | 28 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 72 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 8 h PD: None | 27 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 120 h PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Temperature: 1st Inj, 120 h PD: Normal | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 7 days PD: None | 26 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Tenderness: 4th Inj, 8 h PD: Mild | 1 Participants |
| BIIB019 (Autoinjector [AI]) | Summary of Injection Site Assessment Performed by Clinician | Induration: 1st Inj, 10 days PD: None | 26 Participants |
Secondary
Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4
Time frame: Day 90 (Week 12) at predose and 8, 24, 72 and 120 hours post-dose and 7, 10, 14, 21 and 28 days post-dose
Population: Pharmacokinetic analysis population included all participants with a sufficient number of samples available for analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BIIB019 | Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4 | 5.0 hour |
| BIIB019 (Autoinjector [AI]) | Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4 | 6.0 hour |