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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/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
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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
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Secondary ID [1]
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2009-012500-11
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Secondary ID [2]
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205MS301
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Universal Trial Number (UTN)
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Trial acronym
(DECIDE)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Relapsing-Remitting Multiple Sclerosis
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - BIIB019 (Daclizumab High Yield Process)
Treatment: Drugs - Interferon beta-1a Placebo
Other interventions - 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
Other interventions: 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
Other interventions: Interferon beta-1a
Interferon beta-1a for intramuscular injection
Treatment: Drugs: Daclizumab High Yield Process Placebo
Placebo to Daclizumab High Yield Process subcutaneous injection
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Intervention code [1]
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Other interventions
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Adjusted Annualized Relapse Rate (ARR)
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Assessment method [1]
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Relapses are defined as new or recurrent neurological 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. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; = 2.5 vs > 2.5) and baseline age (= 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.
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Timepoint [1]
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Up to 144 weeks
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Secondary outcome [1]
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Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
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Assessment method [1]
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The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (= 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.
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Timepoint [1]
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up to 96 weeks
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Secondary outcome [2]
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Proportion of Participants With Sustained Disability Progression at 144 Weeks
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Assessment method [2]
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Sustained disability progression is defined as: at least a 1.0-point increase on the EDSS from Baseline EDSS = 1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.
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Timepoint [2]
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Baseline through 144 weeks
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Secondary outcome [3]
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Proportion of Participants Relapse-free at Week 144
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Assessment method [3]
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Relapses are defined as new or recurrent neurological 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. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.
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Timepoint [3]
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144 weeks
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Secondary outcome [4]
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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
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Assessment method [4]
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The MSIS-29 is a 29-item disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of = 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.
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Timepoint [4]
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Baseline and 96 weeks
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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
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Minimum age
18
Years
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Maximum age
55
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2014
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Sample size
Target
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Accrual to date
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Final
1841
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Research Site - Camperdown
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Research Site - New Lambton Heights
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Research Site - Auchenflower
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Research Site - Woodville
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Research Site - Heidelberg West
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Recruitment postcode(s) [1]
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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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Recruitment outside Australia
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Kfar Saba
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Country [111]
0
0
Israel
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State/province [111]
0
0
Tzfat
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Country [112]
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0
Italy
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State/province [112]
0
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PA
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Country [113]
0
0
Italy
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Torino
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Country [114]
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Italy
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Bari
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Country [115]
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Italy
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State/province [115]
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Cagliari
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Country [116]
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Italy
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Catania
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Country [117]
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Italy
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State/province [117]
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Firenze
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Country [118]
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Italy
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Genova
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Country [119]
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Italy
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Milano
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Country [120]
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Italy
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Padova
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Country [121]
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Italy
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Roma
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Country [122]
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0
Mexico
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Distrito Federal
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Country [123]
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Mexico
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Jalisco
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Country [124]
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Moldova, Republic of
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State/province [124]
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Chisinau
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Country [125]
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Poland
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State/province [125]
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Dolnoslaskie
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Country [126]
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Poland
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Kujawsko-pomorskie
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Country [127]
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Poland
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Lodzkie
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Country [128]
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Poland
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Malopolskie
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Country [129]
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Poland
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State/province [129]
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Mazowieckie
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Country [130]
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Poland
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Podlaskie
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Country [131]
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Poland
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State/province [131]
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Pomorskie
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Country [132]
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Poland
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State/province [132]
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Slaskie
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Country [133]
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Poland
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Swietokrzycie
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Poland
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Poland
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Wielkopolskie
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Country [136]
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Poland
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Zachodniopomorskie
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Country [137]
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Poland
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Bydgoszczas
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Country [138]
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Poland
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State/province [138]
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Plewiska
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Country [139]
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Romania
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Bucuresti
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Country [140]
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Romania
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Cluj
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Country [141]
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Romania
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Timis
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Country [142]
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Romania
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Iasi
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Country [143]
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Romania
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State/province [143]
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Târgu Mures
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Country [144]
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Russian Federation
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Povolje-Tatarstan
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Russian Federation
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Ural
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Country [146]
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Russian Federation
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Yaroslavlr
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Country [147]
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Russian Federation
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Chelyabinsk
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Country [148]
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Russian Federation
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State/province [148]
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Kaluga
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Country [149]
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Russian Federation
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State/province [149]
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Kemerovo
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Country [150]
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Russian Federation
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State/province [150]
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Krasnoyarsk
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Country [151]
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Russian Federation
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State/province [151]
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Moscow
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Country [152]
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Russian Federation
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State/province [152]
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Nizhny Novgorod
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Country [153]
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Russian Federation
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State/province [153]
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Novosibirsk
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Country [154]
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Russian Federation
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Perm
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Country [155]
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Russian Federation
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Saint Petersburg
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Country [156]
0
0
Russian Federation
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State/province [156]
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Smolensk
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Country [157]
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0
Russian Federation
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Tomsk
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Country [158]
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Russian Federation
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State/province [158]
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Tumen
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Country [159]
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Russian Federation
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State/province [159]
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Ufa
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Country [160]
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Serbia
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State/province [160]
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Belgrade
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Country [161]
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Serbia
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State/province [161]
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Kragujevac
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Country [162]
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Serbia
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State/province [162]
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Nis
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Country [163]
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Serbia
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State/province [163]
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Novi Sad
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Country [164]
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Spain
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State/province [164]
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Barcelona
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Country [165]
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Spain
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Cordoba
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Country [166]
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Spain
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State/province [166]
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Girona
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Country [167]
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Spain
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Madrid
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Country [168]
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Spain
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State/province [168]
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Sevilla
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Country [169]
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Sweden
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State/province [169]
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Göteborg
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Country [170]
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Sweden
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Linköping
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Country [171]
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Sweden
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Malmö
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Country [172]
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Sweden
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Stockholm
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Country [173]
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Basel
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Country [174]
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Switzerland
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Lugano
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Country [175]
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Ukraine
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State/province [175]
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Dnepropetrovsk
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Country [176]
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Ukraine
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State/province [176]
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Kharkiv
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Country [177]
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Ukraine
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Kyviv
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Country [178]
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Ukraine
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Odessa
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Country [179]
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Ukraine
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State/province [179]
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Poltava
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Country [180]
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Ukraine
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State/province [180]
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Vinnitsa
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Country [181]
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Ukraine
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Zaporozhye
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Country [182]
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United Kingdom
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State/province [182]
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Brighton
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Country [183]
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United Kingdom
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Bristol
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Country [184]
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United Kingdom
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Edinburgh
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Country [185]
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United Kingdom
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London
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Country [186]
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United Kingdom
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New Castle Upon Tyne
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Country [187]
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United Kingdom
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Nottingham
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Country [188]
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United Kingdom
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Romford
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Country [189]
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United Kingdom
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Salford
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Country [190]
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Biogen
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Address
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Other collaborator category [1]
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0
Commercial sector/Industry
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AbbVie
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01064401
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Public notes
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Contacts
Principal investigator
Name
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0
Medical Director
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Address
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0
Biogen
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01064401
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