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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01064401




Registration number
NCT01064401
Ethics application status
Date submitted
26/01/2010
Date registered
8/02/2010
Date last updated
11/07/2016

Titles & IDs
Public title
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon ß 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Scientific title
Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon ß 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
Secondary ID [1] 0 0
2009-012500-11
Secondary ID [2] 0 0
205MS301
Universal Trial Number (UTN)
Trial acronym
(DECIDE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - BIIB019 (Daclizumab High Yield Process)
Treatment: Drugs - Interferon beta-1a Placebo
Treatment: Other - Interferon beta-1a
Treatment: Drugs - Daclizumab High Yield Process Placebo

Experimental: Daclizumab High Yield Process 150 mg SC - Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN ß-1a intramuscular (IM) injection once weekly for 96 to 144 weeks

Active comparator: IFN ß-1a 30 µg IM - Interferon beta-1a (IFN ß-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks


Treatment: Other: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process for subcutaneous injection

Treatment: Drugs: Interferon beta-1a Placebo
Placebo to interferon beta-1a intramuscular injection

Treatment: Other: Interferon beta-1a
Interferon beta-1a for intramuscular injection

Treatment: Drugs: Daclizumab High Yield Process Placebo
Placebo to Daclizumab High Yield Process subcutaneous injection
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adjusted Annualized Relapse Rate (ARR)
Timepoint [1] 0 0
Up to 144 weeks
Secondary outcome [1] 0 0
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
Timepoint [1] 0 0
up to 96 weeks
Secondary outcome [2] 0 0
Proportion of Participants With Sustained Disability Progression at 144 Weeks
Timepoint [2] 0 0
Baseline through 144 weeks
Secondary outcome [3] 0 0
Proportion of Participants Relapse-free at Week 144
Timepoint [3] 0 0
144 weeks
Secondary outcome [4] 0 0
Percentage of Participants With a = 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks
Timepoint [4] 0 0
Baseline and 96 weeks

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/07/2014
Sample size
Target
Accrual to date
Final
1841
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - New Lambton Heights
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Research Site - Auchenflower
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Research Site - Woodville
Recruitment hospital [5] 0 0
Research Site - Fitzroy
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Research Site - Heidelberg West
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- Camperdown
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- New Lambton Heights
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- Auchenflower
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- Woodville
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- Fitzroy
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- Heidelberg West
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biogen
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AbbVie
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon ß 1a (IFN ß-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 ß-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.
Trial website
https://clinicaltrials.gov/study/NCT01064401
Trial related presentations / publications
Cohan S, Kappos L, Giovannoni G, Wiendl H, Selmaj K, Havrdova EK, Rose J, Greenberg S, Phillips G, Ma W, Wang P, Lima G, Sabatella G. Efficacy of daclizumab beta versus intramuscular interferon beta-1a on disability progression across patient demographic and disease activity subgroups in DECIDE. Mult Scler. 2018 Dec;24(14):1883-1891. doi: 10.1177/1352458517735190. Epub 2017 Oct 6.
Benedict RH, Cohan S, Lynch SG, Riester K, Wang P, Castro-Borrero W, Elkins J, Sabatella G. Improved cognitive outcomes in patients with relapsing-remitting multiple sclerosis treated with daclizumab beta: Results from the DECIDE study. Mult Scler. 2018 May;24(6):795-804. doi: 10.1177/1352458517707345. Epub 2017 May 9.
Liu Y, Vollmer T, Havrdova E, Riester K, Lee A, Phillips G, Wang P, Sabatella G. Impact of daclizumab versus interferon beta-1a on patient-reported outcomes in relapsing-remitting multiple sclerosis. Mult Scler Relat Disord. 2017 Jan;11:18-24. doi: 10.1016/j.msard.2016.11.005. Epub 2016 Nov 13.
Krueger JG, Kircik L, Hougeir F, Friedman A, You X, Lucas N, Greenberg SJ, Sweetser M, Castro-Borrero W, McCroskery P, Elkins J. 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 Jul;33(7):1231-45. doi: 10.1007/s12325-016-0353-2. Epub 2016 Jun 1.
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Public notes

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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01064401