The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

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

Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
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 - 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.
Timepoint [1] 0 0
up to 96 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline through 144 weeks
Secondary outcome [3] 0 0
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.
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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Recruitment hospital [3] 0 0
Research Site - Auchenflower
Recruitment hospital [4] 0 0
Research Site - Woodville
Recruitment hospital [5] 0 0
Research Site - Fitzroy
Recruitment hospital [6] 0 0
Research Site - Heidelberg West
Recruitment postcode(s) [1] 0 0
- Camperdown
Recruitment postcode(s) [2] 0 0
- New Lambton Heights
Recruitment postcode(s) [3] 0 0
- Auchenflower
Recruitment postcode(s) [4] 0 0
- Woodville
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Heidelberg West
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Maryland
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New Mexico
Country [19] 0 0
United States of America
State/province [19] 0 0
New York
Country [20] 0 0
United States of America
State/province [20] 0 0
North Carolina
Country [21] 0 0
United States of America
State/province [21] 0 0
Oregon
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Vermont
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
Wisconsin
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Mendoza
Country [31] 0 0
Argentina
State/province [31] 0 0
Santa Fe
Country [32] 0 0
Brazil
State/province [32] 0 0
Bahia
Country [33] 0 0
Brazil
State/province [33] 0 0
Distrito Federal
Country [34] 0 0
Brazil
State/province [34] 0 0
Pernambuco
Country [35] 0 0
Brazil
State/province [35] 0 0
Rio Grande
Country [36] 0 0
Brazil
State/province [36] 0 0
Sao Paulo
Country [37] 0 0
Brazil
State/province [37] 0 0
Rio de Janeiro
Country [38] 0 0
Canada
State/province [38] 0 0
Alberta
Country [39] 0 0
Canada
State/province [39] 0 0
British Columbia
Country [40] 0 0
Canada
State/province [40] 0 0
Newfoundland and Labrador
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Canada
State/province [43] 0 0
Saskatchewan
Country [44] 0 0
Czech Republic
State/province [44] 0 0
Jihocesky Kraj
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Kraj Vysocina
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Olomoucký kraj
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Praha
Country [48] 0 0
Czech Republic
State/province [48] 0 0
Severomoravksy Krav
Country [49] 0 0
Czech Republic
State/province [49] 0 0
Brno
Country [50] 0 0
Czech Republic
State/province [50] 0 0
Hradec Kralove
Country [51] 0 0
Czech Republic
State/province [51] 0 0
Jihlava
Country [52] 0 0
Czech Republic
State/province [52] 0 0
Ostrava
Country [53] 0 0
Czech Republic
State/province [53] 0 0
Pardubice
Country [54] 0 0
Denmark
State/province [54] 0 0
Copenhagen
Country [55] 0 0
Denmark
State/province [55] 0 0
Glostrup
Country [56] 0 0
Denmark
State/province [56] 0 0
Odense C
Country [57] 0 0
Denmark
State/province [57] 0 0
Århus
Country [58] 0 0
Finland
State/province [58] 0 0
Western Finalnd
Country [59] 0 0
Finland
State/province [59] 0 0
Helsinki
Country [60] 0 0
Finland
State/province [60] 0 0
Oulu
Country [61] 0 0
Finland
State/province [61] 0 0
Seinäjoki
Country [62] 0 0
Finland
State/province [62] 0 0
Turku
Country [63] 0 0
France
State/province [63] 0 0
Alsace
Country [64] 0 0
France
State/province [64] 0 0
Basse-normandie
Country [65] 0 0
France
State/province [65] 0 0
Ile-de-france
Country [66] 0 0
France
State/province [66] 0 0
Picardie
Country [67] 0 0
France
State/province [67] 0 0
Provence Alpes Cote D'azur
Country [68] 0 0
France
State/province [68] 0 0
Rhone-alpes
Country [69] 0 0
France
State/province [69] 0 0
Bourdeaux
Country [70] 0 0
France
State/province [70] 0 0
Dijon
Country [71] 0 0
France
State/province [71] 0 0
Lille
Country [72] 0 0
France
State/province [72] 0 0
Lomme
Country [73] 0 0
France
State/province [73] 0 0
Marseille Cedex 9
Country [74] 0 0
France
State/province [74] 0 0
Nancy
Country [75] 0 0
France
State/province [75] 0 0
Toulouse Cedex 3
Country [76] 0 0
Georgia
State/province [76] 0 0
Tbilisi
Country [77] 0 0
Germany
State/province [77] 0 0
Baden-wuerttemberg
Country [78] 0 0
Germany
State/province [78] 0 0
Baden-Wurttemberg
Country [79] 0 0
Germany
State/province [79] 0 0
Bayern
Country [80] 0 0
Germany
State/province [80] 0 0
Hessen
Country [81] 0 0
Germany
State/province [81] 0 0
Nordrhein Westfalen
Country [82] 0 0
Germany
State/province [82] 0 0
Nordrhein-Westfalen
Country [83] 0 0
Germany
State/province [83] 0 0
Rheinland-Pfalz
Country [84] 0 0
Germany
State/province [84] 0 0
Sachsen
Country [85] 0 0
Germany
State/province [85] 0 0
Berlin
Country [86] 0 0
Germany
State/province [86] 0 0
Hamburg
Country [87] 0 0
Germany
State/province [87] 0 0
Tübingen
Country [88] 0 0
Greece
State/province [88] 0 0
Attica
Country [89] 0 0
Greece
State/province [89] 0 0
Crete
Country [90] 0 0
Greece
State/province [90] 0 0
Macedoni
Country [91] 0 0
Hungary
State/province [91] 0 0
Fejer
Country [92] 0 0
Hungary
State/province [92] 0 0
Gyor-moson-sopron
Country [93] 0 0
Hungary
State/province [93] 0 0
Budapest
Country [94] 0 0
Hungary
State/province [94] 0 0
Esztergom
Country [95] 0 0
Hungary
State/province [95] 0 0
Miskolc
Country [96] 0 0
Hungary
State/province [96] 0 0
Nyíregyháza
Country [97] 0 0
Hungary
State/province [97] 0 0
Veszprém
Country [98] 0 0
India
State/province [98] 0 0
Andhra Pradesh
Country [99] 0 0
India
State/province [99] 0 0
Dwivdee
Country [100] 0 0
India
State/province [100] 0 0
Karnataka
Country [101] 0 0
India
State/province [101] 0 0
Kerala
Country [102] 0 0
India
State/province [102] 0 0
Maharashtra
Country [103] 0 0
India
State/province [103] 0 0
New Delhi
Country [104] 0 0
Ireland
State/province [104] 0 0
Dublin
Country [105] 0 0
Israel
State/province [105] 0 0
Ashqelon
Country [106] 0 0
Israel
State/province [106] 0 0
Beer Yaakov
Country [107] 0 0
Israel
State/province [107] 0 0
Petah Tiqwa
Country [108] 0 0
Israel
State/province [108] 0 0
Beer-Sheva
Country [109] 0 0
Israel
State/province [109] 0 0
Haifa
Country [110] 0 0
Israel
State/province [110] 0 0
Kfar Saba
Country [111] 0 0
Israel
State/province [111] 0 0
Tzfat
Country [112] 0 0
Italy
State/province [112] 0 0
PA
Country [113] 0 0
Italy
State/province [113] 0 0
Torino
Country [114] 0 0
Italy
State/province [114] 0 0
Bari
Country [115] 0 0
Italy
State/province [115] 0 0
Cagliari
Country [116] 0 0
Italy
State/province [116] 0 0
Catania
Country [117] 0 0
Italy
State/province [117] 0 0
Firenze
Country [118] 0 0
Italy
State/province [118] 0 0
Genova
Country [119] 0 0
Italy
State/province [119] 0 0
Milano
Country [120] 0 0
Italy
State/province [120] 0 0
Padova
Country [121] 0 0
Italy
State/province [121] 0 0
Roma
Country [122] 0 0
Mexico
State/province [122] 0 0
Distrito Federal
Country [123] 0 0
Mexico
State/province [123] 0 0
Jalisco
Country [124] 0 0
Moldova, Republic of
State/province [124] 0 0
Chisinau
Country [125] 0 0
Poland
State/province [125] 0 0
Dolnoslaskie
Country [126] 0 0
Poland
State/province [126] 0 0
Kujawsko-pomorskie
Country [127] 0 0
Poland
State/province [127] 0 0
Lodzkie
Country [128] 0 0
Poland
State/province [128] 0 0
Malopolskie
Country [129] 0 0
Poland
State/province [129] 0 0
Mazowieckie
Country [130] 0 0
Poland
State/province [130] 0 0
Podlaskie
Country [131] 0 0
Poland
State/province [131] 0 0
Pomorskie
Country [132] 0 0
Poland
State/province [132] 0 0
Slaskie
Country [133] 0 0
Poland
State/province [133] 0 0
Swietokrzycie
Country [134] 0 0
Poland
State/province [134] 0 0
Warminsko-mazurskie
Country [135] 0 0
Poland
State/province [135] 0 0
Wielkopolskie
Country [136] 0 0
Poland
State/province [136] 0 0
Zachodniopomorskie
Country [137] 0 0
Poland
State/province [137] 0 0
Bydgoszczas
Country [138] 0 0
Poland
State/province [138] 0 0
Plewiska
Country [139] 0 0
Romania
State/province [139] 0 0
Bucuresti
Country [140] 0 0
Romania
State/province [140] 0 0
Cluj
Country [141] 0 0
Romania
State/province [141] 0 0
Timis
Country [142] 0 0
Romania
State/province [142] 0 0
Iasi
Country [143] 0 0
Romania
State/province [143] 0 0
Târgu Mures
Country [144] 0 0
Russian Federation
State/province [144] 0 0
Povolje-Tatarstan
Country [145] 0 0
Russian Federation
State/province [145] 0 0
Ural
Country [146] 0 0
Russian Federation
State/province [146] 0 0
Yaroslavlr
Country [147] 0 0
Russian Federation
State/province [147] 0 0
Chelyabinsk
Country [148] 0 0
Russian Federation
State/province [148] 0 0
Kaluga
Country [149] 0 0
Russian Federation
State/province [149] 0 0
Kemerovo
Country [150] 0 0
Russian Federation
State/province [150] 0 0
Krasnoyarsk
Country [151] 0 0
Russian Federation
State/province [151] 0 0
Moscow
Country [152] 0 0
Russian Federation
State/province [152] 0 0
Nizhny Novgorod
Country [153] 0 0
Russian Federation
State/province [153] 0 0
Novosibirsk
Country [154] 0 0
Russian Federation
State/province [154] 0 0
Perm
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Saint Petersburg
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Smolensk
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Tomsk
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Tumen
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Ufa
Country [160] 0 0
Serbia
State/province [160] 0 0
Belgrade
Country [161] 0 0
Serbia
State/province [161] 0 0
Kragujevac
Country [162] 0 0
Serbia
State/province [162] 0 0
Nis
Country [163] 0 0
Serbia
State/province [163] 0 0
Novi Sad
Country [164] 0 0
Spain
State/province [164] 0 0
Barcelona
Country [165] 0 0
Spain
State/province [165] 0 0
Cordoba
Country [166] 0 0
Spain
State/province [166] 0 0
Girona
Country [167] 0 0
Spain
State/province [167] 0 0
Madrid
Country [168] 0 0
Spain
State/province [168] 0 0
Sevilla
Country [169] 0 0
Sweden
State/province [169] 0 0
Göteborg
Country [170] 0 0
Sweden
State/province [170] 0 0
Linköping
Country [171] 0 0
Sweden
State/province [171] 0 0
Malmö
Country [172] 0 0
Sweden
State/province [172] 0 0
Stockholm
Country [173] 0 0
Switzerland
State/province [173] 0 0
Basel
Country [174] 0 0
Switzerland
State/province [174] 0 0
Lugano
Country [175] 0 0
Ukraine
State/province [175] 0 0
Dnepropetrovsk
Country [176] 0 0
Ukraine
State/province [176] 0 0
Kharkiv
Country [177] 0 0
Ukraine
State/province [177] 0 0
Kyviv
Country [178] 0 0
Ukraine
State/province [178] 0 0
Odessa
Country [179] 0 0
Ukraine
State/province [179] 0 0
Poltava
Country [180] 0 0
Ukraine
State/province [180] 0 0
Vinnitsa
Country [181] 0 0
Ukraine
State/province [181] 0 0
Zaporozhye
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Brighton
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Bristol
Country [184] 0 0
United Kingdom
State/province [184] 0 0
Edinburgh
Country [185] 0 0
United Kingdom
State/province [185] 0 0
London
Country [186] 0 0
United Kingdom
State/province [186] 0 0
New Castle Upon Tyne
Country [187] 0 0
United Kingdom
State/province [187] 0 0
Nottingham
Country [188] 0 0
United Kingdom
State/province [188] 0 0
Romford
Country [189] 0 0
United Kingdom
State/province [189] 0 0
Salford
Country [190] 0 0
United Kingdom
State/province [190] 0 0
Sheffield

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/show/NCT01064401
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Biogen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications