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CompletedNCT01051349SELECTEDUpdated Nov 9, 2018Results posted

Safety and Efficacy Extension Study of Daclizumab High Yield Process (DAC HYP) (BIIB019) in Participants Who Have Completed Study 205MS202 (NCT00870740) to Treat Relapsing Remitting Multiple Sclerosis

A Phase 2 interventional study of BIIB019 (Daclizumab) and trivalent seasonal influenza vaccine in Relapsing-Remitting Multiple Sclerosis, sponsored by Biogen. Completed at 65 sites in 8 countries. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2018-11-09.

Sponsored by Biogen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
410
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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,

02

Conditions studied

  • Relapsing-Remitting Multiple Sclerosis

Keywords

  • MS
  • Multiple Sclerosis
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 410 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Biogen is the lead sponsor of 494 studies on the registry; 22 are open to participants now.

Of its 98 completed or terminated interventional studies of FDA-regulated products, 49 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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/Exclusion criteria may apply.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
410 participants (actual)

Study arms

  • Experimental
    BIIB019

    Participants received BIIB019, 150 mg subcutaneous injection every 4 weeks up to Week 288.

    Biological: BIIB019 (Daclizumab) · Biological: trivalent seasonal influenza vaccine

Interventions

  • BiologicalBIIB019 (Daclizumab)

    Administered as specified in the treatment arm.

    Also known as: Daclizumab High Yield Process, DAC HYP

  • Biologicaltrivalent seasonal influenza vaccine

    All participants who participate in the 2013-2014 influenza vaccine substudy will receive the vaccine at the study site

06

What researchers measure

Primary outcomes

  1. 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)

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Annual Change in Number of T1 Hypointense Lesions

    Time frame: From Baseline through 288 weeks

  5. Annual Change in Volume of New Gadolinium-Enhancing Lesions

    Time frame: From Baseline through 288 weeks

  6. 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

  7. 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

  8. Number of Participants With Antibodies to DAC HYP

    Time frame: Up to Week 288

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

07

Results

Posted Nov 9, 2018

Participant flow

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).

Participant flow — Overall Study
MilestoneBIIB019
Started410
Completed237
Not completed173
Withdrew: Adverse event88
Withdrew: Consent withdrawn54
Withdrew: Investigator decision6
Withdrew: Lost to follow-up6
Withdrew: Subject non-compliance7
Withdrew: Reason not specified12

Outcome measures

PrimaryNumber 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)
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuation Due to AEs, Withdrawals Due to AEs
ParticipantsBIIB019
Number of participants with an AEs358
Number of participants with SAEs148
Participants discontinuing treatment due to AE91
Participants withdrawing from study due to AE90
PrimaryArea 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
Reported as:
Mean · hr*mg/mL
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab
hr*mg/mLBIIB019 (Prefilled Syringe [PFS])BIIB019 (Autoinjector [AI])
Area Under the Concentration-Time Curve Over the Dosing Interval (AUC0-t) After Dose 4 for Daclizumab610.5 ± 253.89666.8 ± 253.19
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
ParticipantsBIIB019
Week 48 New or newly enlarging T2 lesions=0255
Week 48 New or newly enlarging T2 lesions=139
Week 48 New or newly enlarging T2 lesions=227
Week 48 New or newly enlarging T2 lesions=312
Week 48 New or newly enlarging T2 lesions=45
Week 48 New/newly enlarging T2 lesions=5-66
Week 48 New/newly enlarging T2 lesions=7-108
Week 48 New/newly enlarging T2 lesions>=1111
Week 96 New/newly enlarging T2 lesions=0213
Week 96 New/newly enlarging T2 lesions=141
Week 96 New/newly enlarging T2 lesions=217
Week 96 New/newly enlarging T2 lesions=317
Week 96 New/newly enlarging T2 lesions=411
Week 96 New/newly enlarging T2 lesions=5-66
Week 96 New/newly enlarging T2 lesions=7-1010
Week 96 New/newly enlarging T2 lesions>=1118
Week 144 New/newly enlarging T2 lesions=033
Week 144 New/newly enlarging T2 lesions=15
Week 144 New/newly enlarging T2 lesions=21
Week 144 New/newly enlarging T2 lesions=32
Week 144 New/newly enlarging T2 lesions=41
Week 144 New/newly enlarging T2 lesions=5-64
Week 144 New/newly enlarging T2 lesions=7-101
Week 144 New/newly enlarging T2 lesions>=116
Week 192 New/newly enlarging T2 lesions=0144
Week 192 New/newly enlarging T2 lesions=130
Week 192 New/newly enlarging T2 lesions=224
Week 192 New/newly enlarging T2 lesions=313
Week 192 New/newly enlarging T2 lesions=49
Week 192 Ne/newly enlarging T2 lesions=5-611
Week 192 New/newly enlarging T2lesions=7-1011
Week 192 New/newly enlarging T2 lesions>=1120
Week 240 New/newly enlarging T2 lesions=060
Week 240 New/newly enlarging T2 lesions=110
Week 240 New/newly enlarging T2 lesions=214
Week 240 New/newly enlarging T2 lesions=39
Week 240 New/newly enlarging T2 lesions=47
Week 240 New/newly enlarging T2 lesions=5-67
Week 240 New/newly enlarging T2lesions=7-103
Week 240 New/newly enlarging T2 lesions>=1111
Week 288 New/newly enlarging T2 lesions=014
Week 288 New/newly enlarging T2 lesions=11
Week 288 New/newly enlarging T2 lesions=24
Week 288 New/ newly enlarging T2 lesions=31
Week 288 New/newly enlarging T2 lesions=40
Week 288 New/newly enlarging T2 lesions=5-61
Week 288 New/newly enlarging T2 lesions=7-103
Week 288 New/newly enlarging T2 lesions>=113
SecondaryAnnual 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
Reported as:
Mean · mm^3
Annual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
mm^3BIIB019
Change from Baseline at Week 48-340.8 ± 1237.64
Change from Baseline at Week 96-237.7 ± 1382.86
Change from Baseline at Week 14438.2 ± 1825.06
Change from Baseline at Week 192-251.2 ± 2326.41
Change from Baseline at Week 240-269.7 ± 1188.82
Change from Baseline at Week 28831.9 ± 1008.87
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Total Number of New Gadolinium-enhancing Lesions
ParticipantsBIIB019
Week 48 new Gd-enhancing lesions=122
Week 48 new Gd-enhancing lesions=23
Week 48 new Gd-enhancing lesions=36
Week 48 new Gd-enhancing lesions=>411
Week 96 new Gd-enhancing lesions=114
Week 96 new Gd-enhancing lesions=27
Week 96 new Gd-enhancing lesions=34
Week 96 new Gd-enhancing lesions=>45
Week 144 new Gd-enhancing lesions=11
Week 144 new Gd-enhancing lesions=20
Week 144 new Gd-enhancing lesions=31
Week 144 new Gd-enhancing lesions=>42
Week 192 new Gd-enhancing lesions=113
Week 192 new Gd-enhancing lesions=25
Week 192 new Gd-enhancing lesions=31
Week 192 new Gd-enhancing lesions=>40
Week 240 new Gd-enhancing lesions=15
Week 240 new Gd-enhancing lesions=20
Week 240 new Gd-enhancing lesions=30
Week 240 new Gd-enhancing lesions=>40
Week 288 new Gd-enhancing lesions=12
Week 288 new Gd-enhancing lesions=20
Week 288 new Gd-enhancing lesions=30
Week 288 new Gd-enhancing lesions=>40
SecondaryAnnual Change in Number of T1 Hypointense Lesions
Time frame:
From Baseline through 288 weeks

No measurements were reported for this outcome.

SecondaryAnnual Change in Volume of New Gadolinium-Enhancing Lesions
Time frame:
From Baseline through 288 weeks

No measurements were reported for this outcome.

SecondaryAnnual 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
Reported as:
Mean · mm^3
Annual Change in Volume of T1 Hypointense Lesions
mm^3BIIB019
Change from Baseline at Week 48-183.5 ± 370.66
Change from Baseline at Week 96-160.6 ± 443.78
Change from Baseline at Week 144-142.4 ± 432.57
Change from Baseline at Week 192-115.2 ± 826.84
Change from Baseline at Week 240-140.8 ± 514.38
Change from Baseline at Week 288-148.4 ± 500.07
SecondaryPercent 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
Reported as:
Mean · percent change
Percent Change in Total Brain Volume
percent changeBIIB019
Change from Week 0 to Week 48-0.4 ± 1.00
Change from Week 48 to Week 96-0.4 ± 0.78
Change from Week 96 to Week 144-0.2 ± 1.00
Change from Week 144 to Week 192-0.5 ± 0.59
Change from Week 192 to Week 240-0.2 ± 0.83
Change from Week 240 to Week 2880.1 ± 0.73
SecondaryNumber of Participants With Antibodies to DAC HYP
Time frame:
Up to Week 288
Reported as:
Count of participants · Participants
Number of Participants With Antibodies to DAC HYP
ParticipantsBIIB019
Number of Participants With Antibodies to DAC HYP43
SecondaryAnnualized 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
Reported as:
Number · relapses per person-year
Annualized Relapse Rate (ARR)
relapses per person-yearBIIB019
Annualized Relapse Rate (ARR)0.124 (0.099 to 0.156)
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Sustained Disability Progression for 12 Weeks
ParticipantsBIIB019
Weeks 0 - 4822
Weeks 49 - 9617
Weeks 97 - 14413
Weeks 145 -1927
Week 193 - 2882
SecondaryNumber 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
Reported as:
Count of participants · Participants
Number of Participants With Sustained Disability Progression for 24 Weeks
ParticipantsBIIB019
Weeks 0 - 4819
Weeks 49 - 9618
Weeks 97 - 14411
Weeks 145 -1927
Week 193 - 2883
SecondaryObserved 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
Reported as:
Mean · mg/mL
Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab
mg/mLBIIB019 (Prefilled Syringe [PFS])BIIB019 (Autoinjector [AI])
Observed Maximum Concentration (Cmax) After Dose 4 for Daclizumab31.8 ± 13.1133.6 ± 14.79
SecondaryTime 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
Reported as:
Median · hour
Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 4
hourBIIB019 (Prefilled Syringe [PFS])BIIB019 (Autoinjector [AI])
Time to Reach Maximum Concentration (Tmax) for Daclizumab After Dose 45.0 (1 to 14)6.0 (1 to 14)
SecondaryObserved 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
Reported as:
Mean · mg/mL
Observed Minimum Concentration (Cmin) for Daclizumab After Dose 4
mg/mLBIIB019 (Prefilled Syringe [PFS])BIIB019 (Autoinjector [AI])
Observed Minimum Concentration (Cmin) for Daclizumab After Dose 413.8 ± 7.1315.7 ± 7.31
SecondaryParticipant-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
Reported as:
Mean · score on a scale
Participant-Reported Pain Visual Analog Scale (VAS) Score
score on a scaleBIIB019 (Prefilled Syringe [PFS])BIIB019 (Autoinjector [AI])
First injection, 0 hour post-dose12.7 ± 17.4514.5 ± 19.47
First injection, 30 minutes post-dose0.1 ± 0.310.4 ± 1.01
First injection, 60 minutes post-dose0.1 ± 0.250.3 ± 0.60
First injection, 8 hours post-dose0.1 ± 0.250.2 ± 0.50
Fourth injection, 0 hour post-dose14.5 ± 21.715.6 ± 24.70
Fourth injection, 30 minutes post-dose0.9 ± 3.511.3 ± 3.42
Fourth injection, 60 minutes post-dose0.0 ± 0.180.1 ± 0.31
Fourth injection, 8 hours post-dose0.1 ± 0.400.1 ± 0.31
SecondarySummary 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
Reported as:
Count of participants · Participants
Summary of Injection Site Assessment Performed by Clinician
ParticipantsBIIB019 (Prefilled Syringe [PFS])BIIB019 (Autoinjector [AI])
Erythema: Ist Inj 30 min PD: None2929
Erythema:Ist Inj 30 min PD: Mild11
Erythema: Ist Inj 8 h PD: None3029
Erythema:Ist Inj 8 h PD: MIld01
Erythema: Ist Inj 24 h PD: None2827
Erythema: Ist Inj 72 h PD: None2626
Erythema: Ist Inj 120 h PD: None2626
Erythema: Ist Inj 7 days PD: None2626
Erythema: Ist Inj 10 days PD: None2626
Erythema: Ist Inj 14 days PD: None2626
Erythema: 4th Inj 30 min PD: None3028
Erythema: 4th Inj 30 min PD: Mild01
Erythema: 4th Inj 8 h PD: None3028
Erythema: 4th Inj 24 h PD: None3027
Erythema: 4th Inj 72 h PD: None2926
Erythema: 4th Inj 120 h PD: None3027
Erythema: 4th Inj 7 days PD: None3028
Erythema: 4th Inj 10 days PD: None3028
Erythema: 4th Inj 14 days PD: None3028
Pigmentation: 1st Inj, 30 min PD: None3030
Pigmentation: 1st Inj, 8 h PD: None3030
Pigmentation: 1st Inj, 24 h PD: None2827
Pigmentation: 1st Inj, 72 h PD: None2626
Pigmentation: 1st Inj, 120 h PD: None2626
Pigmentation: 1st Inj, 7 days PD: None2626
Pigmentation: 1st Inj, 10 days PD: None2626
Pigmentation: 1st Inj, 14 days PD: None2626
Pigmentation: 4th Inj, 30 min PD: None3028
Pigmentation: 4th Inj, 8 h PD: None3028
Pigmentation: 4th Inj, 24 h PD: None3027
Pigmentation: 4th Inj, 72 h PD: None2826
Pigmentation: 4th Inj, 72 h PD: Hyper-10
Pigmentation: 4th Inj, 120 h PD: None2927
Pigmentation: 4th Inj, 120 h PD: Hyper-10
Pigmentation: 4th Inj, 7 days PD: None3028
Pigmentation: 4th Inj, 10 days PD: None3028
Pigmentation: 4th Inj, 14 days PD: None3028
Induration: 1st Inj, 30 min PD: None3030
Induration: 1st Inj, 8 h PD: None3030
Induration: 1st Inj, 24 h PD: None2827
Induration: 1st Inj, 72 h PD: None2626
Induration: 1st Inj, 120 h PD: None2626
Induration: 1st Inj, 7 days PD: None2626
Induration: 1st Inj, 10 days PD: None2626
Induration: 1st Inj, 14 days PD: None2626
Induration: 4th Inj, 30 min PD: None (n=30, 28)3028
Induration: 4th Inj, 8 h PD: None3028
Induration: 4th Inj, 24 h PD: None3027
Induration: 4th Inj, 72 h PD: None2926
Induration: 4th Inj, 120 h PD: None3027
Induration: 4th Inj, 7 days PD: None3028
Induration: 4th Inj, 10 days PD: None3028
Induration: 4th Inj, 14 days PD: None3028
Tenderness: 1st Inj, 30 min PD: None3029
Tenderness: 1st Inj, 30 min PD: Mild01
Tenderness: 1st Inj, 8 h PD: None3030
Tenderness: 1st Inj, 24 h PD: None2827
Tenderness: 1st Inj, 72 h PD: None2626
Tenderness: 1st Inj, 120 h PD: None2626
Tenderness: 1st Inj, 7 days PD: None2626
Tenderness: 1st Inj, 10 days PD: None2626
Tenderness: 1st Inj, 14 days PD: None2626
Tenderness: 4th Inj, 30 min PD: None3027
Tenderness: 4th Inj, 30 min PD: Mild01
Tenderness: 4th Inj, 8 h PD: None3027
Tenderness: 4th Inj, 8 h PD: Mild01
Tenderness: 4th Inj, 24 h PD: None3027
Tenderness: 4th Inj, 72 h PD: None2926
Tenderness: 4th Inj, 120 h PD: None3027
Tenderness: 4th Inj, 7 days PD: None3028
Tenderness: 4th Inj, 10 days PD: None3028
Tenderness: 4th Inj, 14 days PD: None3028
Temperature: 1st Inj, 30 min PD: Normal3030
Temperature: 1st Inj, 8 h PD: Normal3030
Temperature: 1st Inj, 24 h PD: Normal2827
Temperature: 1st Inj, 72 h PD: Normal2626
Temperature: 1st Inj, 120 h PD: Normal2626
Temperature: 1st Inj, 7 days PD: Normal2626
Temperature: 1st Inj,10 days PD: Normal2626
Temperature: 1st Inj,14 days PD: Normal2626
Temperature: 4th Inj, 30 min PD: Normal3028
Temperature: 4th Inj, 8 h PD: Normal3028
Temperature: 4th Inj, 24 h PD: Normal3027
Temperature: 4th Inj, 72 h PD: Normal2926
Temperature: 4th Inj, 120 h PD: Normal3027
Temperature: 4th Inj, 7 days PD: Normal3028
Temperature: 4th Inj,10 days PD: Normal3028
Temperature: 4th Inj,14 days PD: Normal3028

Adverse events

Collected over Baseline up to 24 weeks after last dose of treatment (Up to 300 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BIIB019—148/410 (36.1%)296/410 (72.2%)
Most frequent serious events
Showing 10 of 119
Most frequent serious events
EventBIIB019
Multiple sclerosis relapseNervous system disorders62/410
LymphadenopathyBlood and lymphatic system disorders6/410
Urinary tract infectionInfections and infestations5/410
Colitis ulcerativeGastrointestinal disorders3/410
Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)3/410
Toxic skin eruptionSkin and subcutaneous tissue disorders3/410
UrticariaSkin and subcutaneous tissue disorders3/410
LymphadenitisBlood and lymphatic system disorders2/410
GastritisGastrointestinal disorders2/410
Autoimmune hepatitisHepatobiliary disorders2/410
Most frequent other events
Showing 10 of 18
Most frequent other events
EventBIIB019
Multiple sclerosis relapseNervous system disorders110/410
NasopharyngitisInfections and infestations68/410
Alanine aminotransferase increasedInvestigations61/410
Upper respiratory tract infectionInfections and infestations60/410
Aspartate aminotransferase increasedInvestigations49/410
HeadacheNervous system disorders44/410
PharyngitisInfections and infestations42/410
Urinary tract infectionInfections and infestations42/410
Back painMusculoskeletal and connective tissue disorders39/410
Respiratory tract infection viralInfections and infestations35/410

Baseline characteristics

All participants who were randomized and received at least 1 dose of study drug.

Age, Continuous
Age, Continuous(years)BIIB019
Mean38.4 ± 8.74
Sex: Female, Male
Sex: Female, Male(Participants)BIIB019
Female254
Male156
08

Study locations

65 sites
  • Research Site
    Brno, 625 00, Czechia
  • Research Site
    Brno, 656 91, Czechia
  • Research Site
    Hradec Kralove, 500 02, Czechia
  • Research Site
    Prague, 100 34, Czechia
  • Research Site
    Teplice, 415 29, Czechia
  • Research Site
    Bayreuth, 95445, Germany
  • Research Site
    Erlangen, 91054, Germany
  • Research Site
    Marburg, 35043, Germany
  • Research Site
    Rostock, 18147, Germany
  • Research Site
    Budapest, 1076, Hungary
  • Research Site
    Budapest, 1083, Hungary
  • Research Site
    Budapest, 1115, Hungary
  • Research Site
    Budapest, 1125, Hungary
  • Research Site
    Budapest, 1134, Hungary
  • Research Site
    Debrecen, 4032, Hungary
  • Research Site
    Esztergom, 2500, Hungary
  • Research Site
    Gyor, 9024, Hungary
  • Research Site
    Kecskemet, 6000, Hungary
  • Research Site
    Miskolc, 3526, Hungary
  • Research Site
    Miskolc, 3533, Hungary
  • Research Site
    Nyiregyhaza, 4400, Hungary
  • Research Site
    Siofok, 8600, Hungary
  • Research Site
    Bangalore, 560034, India
  • Research Site
    Hyderabad, 500082, India
  • Research Site
    Kolkata, 700068, India
  • Research Site
    Mumbai, 400012, India
  • Research Site
    Rajasthan, 302021, India
  • Research Site
    Bialystok, 15-276, Poland
  • Research Site
    Bialystok, 15-420, Poland
  • Research Site
    Gdansk, 80-803, Poland
  • Research Site
    Katowice, 40-749, Poland
  • Research Site
    Katowice, 40-752, Poland
  • Research Site
    Krakow, 31-505, Poland
  • Research Site
    Lodz, 93-121, Poland
  • Research Site
    Lublin, 20954, Poland
  • Research Site
    Warsaw, 02-957, Poland
  • Research Site
    Warszawa, 02-097, Poland
  • Research Site
    Kazan, 420021, Russian Federation
  • Research Site
    Krasnoyarsk, 660049, Russian Federation
  • Research Site
    Moscow, 107150, Russian Federation
  • Research Site
    Moscow, 115682, Russian Federation
  • Research Site
    Moscow, 6127018, Russian Federation
  • Research Site
    Nizhniy Novgorod, 603076, Russian Federation
  • Research Site
    Novosibirsk, 630087, Russian Federation
  • Research Site
    Omsk, 644033, Russian Federation
  • Research Site
    Samara, 443095, Russian Federation
  • Research Site
    Smolensk, 214018, Russian Federation
  • Research Site
    St Petersburg, 194291, Russian Federation
  • Research Site
    Ufa, 450005, Russian Federation
  • Research Site
    Yaroskavi, 150030, Russian Federation
  • Research Site
    Chernivtsi, 58018, Ukraine
  • Research Site
    Dnipropetrovsk, 49027, Ukraine
  • Research Site
    Donetsk, 83003, Ukraine
  • Research Site
    Kharkiv, 61068, Ukraine
  • Research Site
    Kiev, 03110, Ukraine
  • Research Site
    Kiev, 2125, Ukraine
  • Research Site
    Kyiv, 03110, Ukraine
  • Research Site
    Poltava, 36024, Ukraine
  • Research Site
    Zaporizhia, 69035, Ukraine
  • Research Site
    Zaporizhia, 69600, Ukraine
  • Research Site
    London, SE59RF, United Kingdom
  • Research Site
    Nottingham, NG72UH, United Kingdom
  • Research Site
    Plymouth, PL68DH, United Kingdom
  • Research Site
    Sheffield, S102JF, United Kingdom
  • Research Site
    Stoke-on-Trent, ST47LN, United Kingdom
09

References and documents

Publications

  • Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova EK, Montalban X, Stefoski D, Sprenger T, Robinson RR, Fam S, Smith J, Chalkias S, Giannattasio G, Lima G, Castro-Borrero W. Long-term safety and efficacy of daclizumab beta in relapsing-remitting multiple sclerosis: 6-year results from the SELECTED open-label extension study. J Neurol. 2020 Oct;267(10):2851-2864. doi: 10.1007/s00415-020-09835-y. Epub 2020 May 25. PubMed 32451615 ↗
  • Gold R, Radue EW, Giovannoni G, Selmaj K, Havrdova E, Stefoski D, Sprenger T, Montalban X, Cohan S, Umans K, Greenberg SJ, Ozen G, Elkins J. Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study. BMC Neurol. 2016 Jul 26;16:117. doi: 10.1186/s12883-016-0635-y. PubMed 27461166 ↗
  • Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13. PubMed 27411694 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01051349
Lead sponsor
Biogen
Collaborators
AbbVie
Responsible party
Sponsor
First posted
Jan 18, 2010
Start date
Mar 31, 2010
Primary completion
Aug 25, 2016
Completion
Aug 25, 2016
Results posted
Nov 9, 2018
Last update
Nov 9, 2018

Study contacts

Medical Director
study director · Biogen

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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