Back to resultsEfficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis ((DECIDE))
Primary Purpose
Relapsing-Remitting Multiple Sclerosis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
BIIB019 (Daclizumab High Yield Process)
Interferon beta-1a Placebo
Interferon beta-1a
Daclizumab High Yield Process Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis
Eligibility Criteria
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.
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Daclizumab High Yield Process 150 mg SC
IFN β-1a 30 µg IM
Arm Description
Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
Outcomes
Primary Outcome Measures
Adjusted Annualized Relapse Rate (ARR)
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.
Secondary Outcome Measures
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
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.
Proportion of Participants With Sustained Disability Progression at 144 Weeks
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.
Proportion of Participants Relapse-free at Week 144
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.
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
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.
Full Information
NCT ID
NCT01064401
First Posted
January 26, 2010
Last Updated
May 31, 2016
Sponsor
Biogen
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT01064401
Brief Title
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
Acronym
(DECIDE)
Official 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 β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
Collaborators
AbbVie
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1841 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Daclizumab High Yield Process 150 mg SC
Arm Type
Experimental
Arm Description
Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
Arm Title
IFN β-1a 30 µg IM
Arm Type
Active Comparator
Arm Description
Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
Intervention Type
Biological
Intervention Name(s)
BIIB019 (Daclizumab High Yield Process)
Other Intervention Name(s)
DAC HYP
Intervention Description
Daclizumab High Yield Process for subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Interferon beta-1a Placebo
Intervention Description
Placebo to interferon beta-1a intramuscular injection
Intervention Type
Biological
Intervention Name(s)
Interferon beta-1a
Other Intervention Name(s)
Avonex, IFN β-1a
Intervention Description
Interferon beta-1a for intramuscular injection
Intervention Type
Drug
Intervention Name(s)
Daclizumab High Yield Process Placebo
Intervention Description
Placebo to Daclizumab High Yield Process subcutaneous injection
Primary Outcome Measure Information:
Title
Adjusted Annualized Relapse Rate (ARR)
Description
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.
Time Frame
Up to 144 weeks
Secondary Outcome Measure Information:
Title
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
Description
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.
Time Frame
up to 96 weeks
Title
Proportion of Participants With Sustained Disability Progression at 144 Weeks
Description
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.
Time Frame
Baseline through 144 weeks
Title
Proportion of Participants Relapse-free at Week 144
Description
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.
Time Frame
144 weeks
Title
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
Description
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.
Time Frame
Baseline and 96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
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Gilbert
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Arizona
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United States
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Phoenix
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Arizona
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United States
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Tucson
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Little Rock
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La Jolla
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Naples
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Sunrise
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Atlanta
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Evanston
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Fort Wayne
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Indianapolis
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Des Moines
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Lexington
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Baltimore
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Springfield
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Worchester
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Clinton Township
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Michigan
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Saint Louis
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Lebanon
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New Brunswick
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Albuquerque
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Buffalo
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Latham
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New York
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New York
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New York
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United States
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Rochester
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New York
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United States
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Charlotte
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Raleigh
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Winston Salem
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Medford
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Portland
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Allentown
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Philadelphia
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Pittsburg
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Providence
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Franklin
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Tennessee
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United States
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Knoxville
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United States
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Salt Lake City
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Utah
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Burlington
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Vermont
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Kirkland
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Seattle
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Washington
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Tacoma
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Milwaukee
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Ciudad Autónoma de Buenos Aires
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Buenos Aires
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Argentina
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Godoy Cruz
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Mendoza
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Argentina
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Rosario
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Santa Fe
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Argentina
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Camperdown
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New South Wales
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Australia
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New Lambton Heights
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New South Wales
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Australia
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Auchenflower
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Queensland
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Australia
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Woodville
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South Australia
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Australia
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Fitzroy
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Victoria
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Australia
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Heidelberg West
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Victoria
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Australia
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Belo Horizonte
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Bahia
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Brazil
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Brasilia
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Brazil
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Recife
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Pernambuco
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Brazil
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Porto Alegre
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Rio Grande
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Brazil
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Sao Paulo
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Rio Grande
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Brazil
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Campinas
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Sao Paulo
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Brazil
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Ribeirão Preto
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Sao Paulo
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Brazil
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Brazil
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Calgary
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Edmonton
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Canada
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Vancouver
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Canada
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Saint John
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Canada
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London
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Canada
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Ottawa
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Ontario
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Canada
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Gatineau
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Quebec
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Canada
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Greenfield Park
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Quebec
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Canada
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Montréal
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Quebec
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Canada
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Regina
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Saskatchewan
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Canada
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Brno
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Jihocesky Kraj
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Czech Republic
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Jihlava
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Kraj Vysocina
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Czech Republic
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Olomouc
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Olomoucký kraj
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Czech Republic
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Praha 10
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Praha
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Czech Republic
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Praha 2
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Praha
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Czech Republic
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Havirov
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Severomoravksy Krav
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Czech Republic
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Brno
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Czech Republic
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Hradec Kralove
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Czech Republic
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Jihlava
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Czech Republic
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Ostrava
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Czech Republic
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Pardubice
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Czech Republic
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Copenhagen
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Denmark
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Glostrup
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Denmark
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Odense C
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Denmark
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Århus
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Denmark
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Tampere
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Western Finalnd
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Finland
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Helsinki
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Finland
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Oulu
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Finland
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Seinäjoki
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Finland
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Turku
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Finland
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Strasbourg
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Alsace
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France
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Caen Cedex 5
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Basse-normandie
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France
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Research Site
City
Bobigny
State/Province
Ile-de-france
Country
France
Facility Name
Research Site
City
Paris Cedex 5
State/Province
Ile-de-france
Country
France
Facility Name
Research Site
City
Paris
State/Province
Ile-de-france
Country
France
Facility Name
Research Site
City
Amiens
State/Province
Picardie
Country
France
Facility Name
Research Site
City
Nice
State/Province
Provence Alpes Cote D'azur
Country
France
Facility Name
Research Site
City
Lyon
State/Province
Rhone-alpes
Country
France
Facility Name
Research Site
City
Bourdeaux
Country
France
Facility Name
Research Site
City
Dijon
Country
France
Facility Name
Research Site
City
Lille
Country
France
Facility Name
Research Site
City
Lomme
Country
France
Facility Name
Research Site
City
Marseille Cedex 9
Country
France
Facility Name
Research Site
City
Nancy
Country
France
Facility Name
Research Site
City
Toulouse Cedex 3
Country
France
Facility Name
Research Site
City
Tbilisi
Country
Georgia
Facility Name
Research Site
City
Freiburg
State/Province
Baden-wuerttemberg
Country
Germany
Facility Name
Research Site
City
Bad Mergentheim
State/Province
Baden-Wurttemberg
Country
Germany
Facility Name
Research Site
City
Bamberg
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
Bayreuth
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
München
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
Neuburg an der Donau
State/Province
Bayern
Country
Germany
Facility Name
Research Site
City
Marburg
State/Province
Hessen
Country
Germany
Facility Name
Research Site
City
Essen
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Research Site
City
Koln
State/Province
Nordrhein Westfalen
Country
Germany
Facility Name
Research Site
City
Munster
State/Province
Nordrhein-Westfalen
Country
Germany
Facility Name
Research Site
City
Trier
State/Province
Rheinland-Pfalz
Country
Germany
Facility Name
Research Site
City
Dresden
State/Province
Sachsen
Country
Germany
Facility Name
Research Site
City
Berlin
Country
Germany
Facility Name
Research Site
City
Hamburg
Country
Germany
Facility Name
Research Site
City
Tübingen
Country
Germany
Facility Name
Research Site
City
Athens
State/Province
Attica
Country
Greece
Facility Name
Research Site
City
Heraklion
State/Province
Crete
Country
Greece
Facility Name
Research Site
City
Thessaloniki
State/Province
Macedoni
Country
Greece
Facility Name
Research Site
City
Székesfehérvár
State/Province
Fejer
Country
Hungary
Facility Name
Research Site
City
Gyor
State/Province
Gyor-moson-sopron
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Esztergom
Country
Hungary
Facility Name
Research Site
City
Miskolc
Country
Hungary
Facility Name
Research Site
City
Nyíregyháza
Country
Hungary
Facility Name
Research Site
City
Veszprém
Country
Hungary
Facility Name
Research Site
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Research Site
City
Delhi
State/Province
Dwivdee
Country
India
Facility Name
Research Site
City
Bangalore
State/Province
Karnataka
Country
India
Facility Name
Research Site
City
Trivandrum
State/Province
Kerala
Country
India
Facility Name
Research Site
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
Nagpur
State/Province
Maharashtra
Country
India
Facility Name
Research Site
City
New Delhi
Country
India
Facility Name
Research Site
City
Dublin
Country
Ireland
Facility Name
Research Site
City
Ashkelon
State/Province
Ashqelon
Country
Israel
Facility Name
Research Site
City
Tzrifin
State/Province
Beer Yaakov
Country
Israel
Facility Name
Research Site
City
Petach Tikva
State/Province
Petah Tiqwa
Country
Israel
Facility Name
Research Site
City
Beer-Sheva
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Kfar Saba
Country
Israel
Facility Name
Research Site
City
Tzfat
Country
Israel
Facility Name
Research Site
City
Cefalù
State/Province
PA
Country
Italy
Facility Name
Research Site
City
Orbassano
State/Province
Torino
Country
Italy
Facility Name
Research Site
City
Bari
Country
Italy
Facility Name
Research Site
City
Cagliari
Country
Italy
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Firenze
Country
Italy
Facility Name
Research Site
City
Genova
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Padova
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Mexico
State/Province
Distrito Federal
Country
Mexico
Facility Name
Research Site
City
Guadalajara
State/Province
Jalisco
Country
Mexico
Facility Name
Research Site
City
Chisinau
Country
Moldova, Republic of
Facility Name
Research Site
City
Lublin
State/Province
Dolnoslaskie
Country
Poland
Facility Name
Research Site
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
Country
Poland
Facility Name
Research Site
City
Grudziadz
State/Province
Kujawsko-pomorskie
Country
Poland
Facility Name
Research Site
City
Lódz
State/Province
Lodzkie
Country
Poland
Facility Name
Research Site
City
Kraków
State/Province
Malopolskie
Country
Poland
Facility Name
Research Site
City
Warszawa
State/Province
Mazowieckie
Country
Poland
Facility Name
Research Site
City
Bialystok
State/Province
Podlaskie
Country
Poland
Facility Name
Research Site
City
Gdansk
State/Province
Pomorskie
Country
Poland
Facility Name
Research Site
City
Katowice
State/Province
Slaskie
Country
Poland
Facility Name
Research Site
City
Kielce
State/Province
Swietokrzycie
Country
Poland
Facility Name
Research Site
City
Olsztyn
State/Province
Warminsko-mazurskie
Country
Poland
Facility Name
Research Site
City
Poznan
State/Province
Wielkopolskie
Country
Poland
Facility Name
Research Site
City
Szczecin
State/Province
Zachodniopomorskie
Country
Poland
Facility Name
Research Site
City
Bydgoszczas
Country
Poland
Facility Name
Research Site
City
Plewiska
Country
Poland
Facility Name
Research Site
City
Bucurest
State/Province
Bucuresti
Country
Romania
Facility Name
Research Site
City
Cluj-Napoca
State/Province
Cluj
Country
Romania
Facility Name
Research Site
City
Timisoara
State/Province
Timis
Country
Romania
Facility Name
Research Site
City
Iasi
Country
Romania
Facility Name
Research Site
City
Târgu Mures
Country
Romania
Facility Name
Research Site
City
Kazan
State/Province
Povolje-Tatarstan
Country
Russian Federation
Facility Name
Research Site
City
Ekaterinburg
State/Province
Ural
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
State/Province
Yaroslavlr
Country
Russian Federation
Facility Name
Research Site
City
Chelyabinsk
Country
Russian Federation
Facility Name
Research Site
City
Kaluga
Country
Russian Federation
Facility Name
Research Site
City
Kemerovo
Country
Russian Federation
Facility Name
Research Site
City
Krasnoyarsk
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
Nizhny Novgorod
Country
Russian Federation
Facility Name
Research Site
City
Novosibirsk
Country
Russian Federation
Facility Name
Research Site
City
Perm
Country
Russian Federation
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Smolensk
Country
Russian Federation
Facility Name
Research Site
City
Tomsk
Country
Russian Federation
Facility Name
Research Site
City
Tumen
Country
Russian Federation
Facility Name
Research Site
City
Ufa
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Kragujevac
Country
Serbia
Facility Name
Research Site
City
Nis
Country
Serbia
Facility Name
Research Site
City
Novi Sad
Country
Serbia
Facility Name
Research Site
City
L´Hospitalet de Llobregat
State/Province
Barcelona
Country
Spain
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Cordoba
Country
Spain
Facility Name
Research Site
City
Girona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Sevilla
Country
Spain
Facility Name
Research Site
City
Göteborg
Country
Sweden
Facility Name
Research Site
City
Linköping
Country
Sweden
Facility Name
Research Site
City
Malmö
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Basel
Country
Switzerland
Facility Name
Research Site
City
Lugano
Country
Switzerland
Facility Name
Research Site
City
Dnepropetrovsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kyviv
Country
Ukraine
Facility Name
Research Site
City
Odessa
Country
Ukraine
Facility Name
Research Site
City
Poltava
Country
Ukraine
Facility Name
Research Site
City
Vinnitsa
Country
Ukraine
Facility Name
Research Site
City
Zaporozhye
Country
Ukraine
Facility Name
Research Site
City
Brighton
Country
United Kingdom
Facility Name
Research Site
City
Bristol
Country
United Kingdom
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
New Castle Upon Tyne
Country
United Kingdom
Facility Name
Research Site
City
Nottingham
Country
United Kingdom
Facility Name
Research Site
City
Romford
Country
United Kingdom
Facility Name
Research Site
City
Salford
Country
United Kingdom
Facility Name
Research Site
City
Sheffield
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
28984179
Citation
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.
Results Reference
derived
PubMed Identifier
28485186
Citation
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.
Results Reference
derived
PubMed Identifier
28104250
Citation
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.
Results Reference
derived
PubMed Identifier
27251051
Citation
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.
Results Reference
derived
PubMed Identifier
26444729
Citation
Kappos L, Wiendl H, Selmaj K, Arnold DL, Havrdova E, Boyko A, Kaufman M, Rose J, Greenberg S, Sweetser M, Riester K, O'Neill G, Elkins J. Daclizumab HYP versus Interferon Beta-1a in Relapsing Multiple Sclerosis. N Engl J Med. 2015 Oct 8;373(15):1418-28. doi: 10.1056/NEJMoa1501481.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
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