SELECTED
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- Daclizumab
Interleukin-2 receptor inhibitor
- trivalent seasonal influenza vaccine
Results by group
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)
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIIB019 | 358 Participants | 410 | |
| BIIB019 | 148 Participants | 410 | |
| BIIB019 | 91 Participants | 410 | |
| BIIB019 | 90 Participants | 410 |
BIIB019
BIIB019
BIIB019
BIIB019
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
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| BIIB019 (Prefilled Syringe [PFS]) | 610.5 hr*mg/mL | 253.89 (Standard Deviation) | 30 |
| BIIB019 (Autoinjector [AI]) | 666.8 hr*mg/mL | 253.19 (Standard Deviation) | 30 |
BIIB019 (Prefilled Syringe [PFS])
BIIB019 (Autoinjector [AI])
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| BIIB019 | 410 | 148 (36.1%) |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
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)
SafetyArea 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
The primary endpoints of the study are AEs, including SAEs,
Safety
Other measures (17)
Number of Participants With New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
From Baseline through 288 weeks
MRI lesionsAnnual Change in Volume of New or Newly Enlarging T2 Hyperintense Lesions Compared to Baseline
From Baseline through 288 weeks
MRI lesionsNumber of Participants With Total Number of New Gadolinium-enhancing Lesions
From Baseline through 288 weeks
MRI lesionsAnnual Change in Number of T1 Hypointense Lesions
From Baseline through 288 weeks
MRI lesionsAnnual Change in Volume of New Gadolinium-Enhancing Lesions
From Baseline through 288 weeks
MRI lesionsAnnual Change in Volume of T1 Hypointense Lesions
From Baseline through 288 weeks
MRI lesionsPercent Change in Total Brain Volume
From Baseline through 288 weeks
MRI lesionsBrain volume lossNumber of Participants With Antibodies to DAC HYP
Up to Week 288
Annualized Relapse Rate (ARR)
Week 288
RelapsesNumber of Participants With Sustained Disability Progression for 12 Weeks
Week 48 up to Week 288
Disability progression
Who could take part
Relapsing MS · 18 to 60
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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
Results
Safety and efficacy of daclizumab in relapsing-remitting multiple sclerosis: 3-year results from the SELECTED open-label extension study.BMC Neurol · 2016
Results
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.
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History
Started
Mar 2010
Main results due
Aug 2016
Finished
Aug 2016
Results posted
Nov 2018
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