SELECT
What it found
The main measure showed a statistically significant benefit.
| Measure | Estimate | 95% CI | p |
|---|---|---|---|
| Adjusted Annualized Relapse Rate Between Baseline and Week 52 | Rate Ratio 0.461 | 0.318–0.668 | <0.0001 |
| Adjusted Annualized Relapse Rate Between Baseline and Week 52 | Rate Ratio 0.503 | 0.352–0.721 | 0.0002 |
Statistical analysis as posted on ClinicalTrials.gov.
What was tested
Treatment tested
- Daclizumab
Interleukin-2 receptor inhibitor
Placebo or sham
- Placebo
Results by group
Adjusted Annualized Relapse Rate Between Baseline and Week 52
Baseline through Week 52
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Placebo | 0.458 relapses per person-years | 0.37–0.566 | 196 |
| 150 mg DAC HYP | 0.211 relapses per person-years | 0.155–0.287 | 201 |
| 300 mg DAC HYP | 0.230 relapses per person-years | 0.172–0.308 | 203 |
Placebo
150 mg DAC HYP
300 mg DAC HYP
p = <0.0001; Rate Ratio 0.461 (95% CI 0.318–0.668)
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Placebo | 204 | 53 (26.0%) | |
| 150 mg DAC HYP | 208 | 32 (15.4%) | |
| 300 mg DAC HYP | 209 | 36 (17.2%) | |
| Total Active | 417 | 68 (16.3%) |
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 Between Baseline and Week 52
Baseline through Week 52
Relapses
Other measures (4)
Adjusted Mean Number of New Gadolinium (Gd)-Enhancing Lesions Between Week 8 and Week 24
Week 8 through Week 24
MRI lesionsAdjusted Mean Number of New or Newly-enlarging T2 Hyperintense Lesions at Week 52
Week 52
MRI lesionsProportion of Participants Who Relapsed at Week 52
Week 52
RelapsesMean Change From Baseline in Multiple Sclerosis Impact Scale (MSIS)-29 Physical Impact Score at Week 52
Baseline and Week 52
Quality of life (reported by participants)
Who could take part
Relapsing MS · 18 to 55
Key Inclusion Criteria: * Multiple Sclerosis (MS) subjects who have a confirmed diagnosis of relapsing-remitting MS according to McDonald criteria #1-4 and a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive, who meet either of the following 2 criteria: * Have experienced at least 1 relapse within the 12 months prior to randomization, with a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS , OR * Show evidence of gadolinium-enhancing lesions of the brain on an MRI performed within the 6 weeks prior to randomization. Key Exclusion Criteria: * Diagnosis of primary progressive, secondary progressive, or progressive relapsing MS * History of malignancy * History of severe allergic or anaphylactic reactions or known drug hypersensitivity * History of abnormal laboratory results based on investigator judgment * History of human immunodeficiency virus (HIV) or other immunodeficient conditions * History of drug or alcohol abuse within the 2 years prior to randomization * 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 * Positive screening for active infection with Hepatitis B virus or Hepatitis C 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. * Abnormal blood tests at Screening: Hemoglobin ≤9.0 g/dL, Platelets ≤100 × 10\^9/L, Lymphocytes ≤1.0 × 10\^9/L, Neutrophils ≤1.5 × 10\^9/L, alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT), aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT), or gamma-glutamyl-transferase >2 times the upper limit of normal (ULN) and serum creatinine >ULN. 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 objective of this study is to determine whether DAC HYP, when compared to placebo, is effective in reducing the rate of relapses between baseline and Week 52. The secondary objectives are to determine whether DAC HYP is effective in reducing the number of new gadolinium (Gd)-enhancing lesions, reducing the number of new or newly-enlarging T2 hyperintense lesions, reducing the proportion of participants with relapses, and improving quality of life.
Papers
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
Responder definition of the Multiple Sclerosis Impact Scale physical impact subscale for patients with physical worsening.Mult Scler · 2014
Results
Daclizumab high-yield process in relapsing-remitting multiple sclerosis (SELECT): a randomised, double-blind, placebo-controlled trial.Lancet · 2013
Results
Huss DJ, Mehta DS, Sharma A, You X, Riester KA, Sheridan JP, Amaravadi LS, Elkins JS, Fontenot JD. In vivo maintenance of human regulatory T cells during CD25 blockade. J Immunol. 2015 Jan 1;194(1):84-92. doi: 10.4049/jimmunol.1402140.
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History
Started
Feb 2008
Main results due
May 2011
Finished
Aug 2011
Results posted
Jul 2016
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