(DECIDE)
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Adjusted Annualized Relapse Rate (ARR) | Rate Ratio 0.550 | 0.469–0.645 | < 0.0001 |
| Adjusted Annualized Relapse Rate (ARR) | Percent Reduction 45.0 | 35.5–53.1 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Daclizumab
Interleukin-2 receptor inhibitor
Compared with
- Interferon beta-1a
Interferon alpha/beta receptor agonist
Placebo or sham
- Interferon beta-1a Placebo
- Daclizumab High Yield Process Placebo
Results by group
Adjusted Annualized Relapse Rate (ARR)
Up to 144 weeks
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Interferon Beta-1a | 0.393 relapses per person-years | 0.353–0.438 | 643 |
| Daclizumab High Yield Process | 0.216 relapses per person-years | 0.191–0.244 | 402 |
Interferon Beta-1a
Daclizumab High Yield Process
p = < 0.0001; Rate Ratio 0.550 (95% CI 0.469–0.645)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| IFN Beta-1a 30 mcg | 922 | 194 (21.0%) | |
| DAC HYP 150 mg | 919 | 221 (24.0%) |
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
Adjusted Annualized Relapse Rate (ARR)
Up to 144 weeks
Disability progressionRelapses• Annualized relapse rate (ARR)
Relapses
Other measures (5)
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
up to 96 weeks
MRI lesionsProportion of Participants With Sustained Disability Progression at 144 Weeks
Baseline through 144 weeks
Disability progressionProportion of Participants Relapse-free at Week 144
144 weeks
RelapsesPercentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks
Baseline and 96 weeks
Quality of life (reported by participants)a) Number of new or newly-enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) over 96 weeks
MRI lesions
Who could take part
Relapsing MS · 18 to 55
Key Inclusion Criteria: * Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS * Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive * Male subjects and female subjects of childbearing potential must be willing to 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: * Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg * History of treatment with Daclizumab High Yield Process (Dac HYP) * History of malignancy * History of severe allergic or anaphylactic reactions * Known hypersensitivity to study drugs or their excipients * History of abnormal laboratory results indicative of any significant disease * History of human immunodeficiency virus (HIV) or other immunodeficient conditions * History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization * History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline * History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1 * An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization * Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus * Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening * Exposure to varicella zoster virus within 21 days before screening 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
The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis. The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.
Papers
Results
Longitudinal Changes in Cognitive Test Scores in Patients With Relapsing-Remitting Multiple Sclerosis: An Analysis of the DECIDE Dataset.Neurology · 2023
Results
Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study.Mult Scler · 2018
Results
Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE.Mult Scler · 2018
Results
Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis.Mult Scler Relat Disord · 2017
Results
Cutaneous Adverse Events in the Randomized, Double-Blind, Active-Comparator DECIDE Study of Daclizumab High-Yield Process Versus Intramuscular Interferon Beta-1a in Relapsing-Remitting Multiple Sclerosis.Adv Ther · 2016
Results
Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis.N Engl J Med · 2015
Results
Effect of daclizumab high-yield process in patients with highly active relapsing-remitting multiple sclerosis.J Neurol · 2014
Results
Loomis SJ, Sadhu N, Fisher E, Gafson AR, Huang Y, Yang C, Hughes EE, Marshall E, Herman A, John S, Runz H, Jia X, Bhangale T, Bronson PG. Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials. Sci Rep. 2023 Aug 31;13(1):14313. doi: 10.1038/s41598-023-41099-0.
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Linked trials
Extended by
EXTENDPhase 3 · Stopped early
Links found where a registry record names another trial's registry number.
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History
Started
May 2010
Main results due
Mar 2014
Finished
Jul 2014
Results posted
Jul 2016
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