Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
(DECIDE)
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
2 other identifiers
interventional
1,841
27 countries
224
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2010
Typical duration for phase_3
224 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 26, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedResults Posted
Study results publicly available
July 11, 2016
CompletedJuly 11, 2016
May 1, 2016
3.8 years
January 26, 2010
May 31, 2016
May 31, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 144 weeks
Secondary Outcomes (4)
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
up to 96 weeks
Proportion of Participants With Sustained Disability Progression at 144 Weeks
Baseline through 144 weeks
Proportion of Participants Relapse-free at Week 144
144 weeks
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
Baseline and 96 weeks
Study Arms (2)
Daclizumab High Yield Process 150 mg SC
EXPERIMENTALDaclizumab 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
IFN β-1a 30 µg IM
ACTIVE COMPARATORInterferon 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
Interventions
Daclizumab High Yield Process for subcutaneous injection
Placebo to interferon beta-1a intramuscular injection
Interferon beta-1a for intramuscular injection
Placebo to Daclizumab High Yield Process subcutaneous injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (228)
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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La Jolla, California, United States
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Aurora, Colorado, United States
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Naples, Florida, United States
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Pompano Beach, Florida, United States
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St. Petersburg, Florida, United States
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Sunrise, Florida, United States
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Atlanta, Georgia, United States
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Evanston, Illinois, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Des Moines, Iowa, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Springfield, Massachusetts, United States
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Worchester, Massachusetts, United States
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Clinton Township, Michigan, United States
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St Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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New Brunswick, New Jersey, United States
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Albuquerque, New Mexico, United States
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Buffalo, New York, United States
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Latham, New York, United States
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New York, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Allentown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Providence, Rhode Island, United States
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Franklin, Tennessee, United States
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Knoxville, Tennessee, United States
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Salt Lake City, Utah, United States
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Burlington, Vermont, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
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Godoy Cruz, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Camperdown, New South Wales, Australia
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New Lambton Heights, New South Wales, Australia
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Auchenflower, Queensland, Australia
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Woodville, South Australia, Australia
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Fitzroy, Victoria, Australia
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Heidelberg West, Victoria, Australia
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Belo Horizonte, Estado de Bahia, Brazil
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Brasília, Federal District, Brazil
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Recife, Pernambuco, Brazil
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Rio de Janeiro, Rio de Janeiro, Brazil
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Porto Alegre, Rio Grande, Brazil
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São Paulo, Rio Grande, Brazil
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Campinas, São Paulo, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Calgary, Alberta, Canada
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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St. John's, Newfoundland and Labrador, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Gatineau, Quebec, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Regina, Saskatchewan, Canada
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Brno, Jihočeský kraj, Czechia
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Jihlava, Kraj Vysočina, Czechia
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Olomouc, Olomoucký kraj, Czechia
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Prague, Prague, Czechia
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Havířov, Severomoravksy Krav, Czechia
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Brno, Czechia
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Hradec Králové, Czechia
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Jihlava, Czechia
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Ostrava, Czechia
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Pardubice, Czechia
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Aarhus, Denmark
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Copenhagen, Denmark
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Glostrup Municipality, Denmark
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Odense C, Denmark
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Oulu, Oulu, Finland
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Tampere, Western Finalnd, Finland
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Helsinki, Finland
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Seinäjoki, Finland
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Turku, Finland
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Strasbourg, Alsace, France
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Lyon, Auvergne-Rhône-Alpes, France
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Caen, Basse-normandie, France
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Amiens, Picardie, France
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Nice, Provence-Alpes-Côte d'Azur Region, France
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Bourdeaux, France
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Dijon, France
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Lille, France
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Lomme, France
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Marseille, France
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Nancy, France
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Toulouse, France
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Bobigny, Île-de-France Region, France
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Paris, Île-de-France Region, France
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Tbilisi, Georgia
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Bad Mergentheim, Baden-Wurttemberg, Germany
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Bamberg, Bavaria, Germany
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Bayreuth, Bavaria, Germany
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München, Bavaria, Germany
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Neuburg an der Donau, Bavaria, Germany
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Hamburg, Hamburg, Germany
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Marburg, Hesse, Germany
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Cologne, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Münster, North Rhine-Westphalia, Germany
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Trier, Rhineland-Palatinate, Germany
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Dresden, Saxony, Germany
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Berlin, State of Berlin, Germany
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Tübingen, Germany
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Athens, Attica, Greece
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Heraklion, Crete, Greece
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Thessaloniki, Macedoni, Greece
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Budapest, Budapest, Hungary
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Székesfehérvár, Fejér, Hungary
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Győr, Győr-Moson-Sopron, Hungary
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Esztergom, Hungary
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Miskolc, Hungary
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Nyíregyháza, Hungary
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Veszprém, Hungary
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Hyderabad, Andhra Pradesh, India
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Delhi, Dwivdee, India
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Bangalore, Karnataka, India
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Trivandrum, Kerala, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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New Delhi, India
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Dublin, Dublin, Ireland
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Ashkelon, Ashqelon, Israel
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Tzrifin, Beer Yaakov, Israel
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Petah Tikva, Petah Tiqwa, Israel
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Beersheba, Israel
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Haifa, Israel
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Kfar Saba, Israel
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Tzfat, Israel
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Bari, Bari, Italy
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Cagliari, Cagliari, Italy
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Catania, Catania, Italy
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Genova, Genova, Italy
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Cefalù, PA, Italy
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Roma, Roma, Italy
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Orbassano, Torino, Italy
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Florence, Italy
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Milan, Italy
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Padua, Italy
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Guadalajara, Jalisco, Mexico
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Mexico City, Mexico City, Mexico
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Chisinau, Moldova
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Poznan, Greater Poland Voivodeship, Poland
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
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Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Lublin, Lower Silesian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Bialystok, Podlaskie Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Kielce, Swietokrzycie, Poland
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Olsztyn, Warmian-Masurian Voivodeship, Poland
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Szczecin, West Pomeranian Voivodeship, Poland
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Bydgoszczas, Poland
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Plewiska, Poland
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Lódz, Łódź Voivodeship, Poland
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Bucurest, București, Romania
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Cluj-Napoca, Cluj, Romania
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Timișoara, Timiș County, Romania
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Iași, Romania
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Târgu Mures, Romania
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Kazan', Povolje-Tatarstan, Russia
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Yekaterinburg, Ural, Russia
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Yaroslavl, Yaroslavlr, Russia
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Chelyabinsk, Russia
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Kaluga, Russia
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Kemerovo, Russia
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Krasnoyarsk, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Novosibirsk, Russia
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Perm, Russia
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Saint Petersburg, Russia
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Smolensk, Russia
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Tomsk, Russia
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Tyumen, Russia
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Ufa, Russia
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Belgrade, Serbia
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Kragujevac, Serbia
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Niš, Serbia
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Novi Sad, Serbia
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Barcelona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Córdoba, Cordoba, Spain
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Madrid, Madrid, Spain
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Seville, Sevilla, Spain
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Girona, Spain
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Gothenburg, Sweden
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Linköping, Sweden
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Malmo, Sweden
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Stockholm, Sweden
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Basel, Basel, Switzerland
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Lugano, Switzerland
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Dnipro, Ukraine
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Kharkiv, Ukraine
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Kyviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Vinnitsa, Ukraine
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Zaporizhzhya, Ukraine
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Brighton, United Kingdom
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Bristol, United Kingdom
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Edinburgh, United Kingdom
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London, United Kingdom
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New Castle Upon Tyne, United Kingdom
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Nottingham, United Kingdom
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Romford, United Kingdom
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Salford, United Kingdom
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Sheffield, United Kingdom
Related Publications (7)
Loomis SJ, Sadhu N, Fisher E, Gafson AR, Huang Y, Yang C, Hughes EE, Marshall E, Herman A, John S, Runz H, Jia X, Bhangale T, Bronson PG. Genome-wide study of longitudinal brain imaging measures of multiple sclerosis progression across six clinical trials. Sci Rep. 2023 Aug 31;13(1):14313. doi: 10.1038/s41598-023-41099-0.
PMID: 37652990DERIVEDCastrogiovanni N, Mostert J, Repovic P, Bowen JD, Uitdehaag BMJ, Strijbis EMM, Cutter GR, Koch MW. Longitudinal Changes in Cognitive Test Scores in Patients With Relapsing-Remitting Multiple Sclerosis: An Analysis of the DECIDE Dataset. Neurology. 2023 Jul 4;101(1):e1-e11. doi: 10.1212/WNL.0000000000207301. Epub 2023 Apr 18.
PMID: 37072219DERIVEDCohan 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.
PMID: 28984179DERIVEDBenedict 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.
PMID: 28485186DERIVEDLiu 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.
PMID: 28104250DERIVEDKrueger 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.
PMID: 27251051DERIVEDKappos 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.
PMID: 26444729DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Biogen Study Medical Director
- Organization
- Biogen
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 26, 2010
First Posted
February 8, 2010
Study Start
May 1, 2010
Primary Completion
March 1, 2014
Study Completion
July 1, 2014
Last Updated
July 11, 2016
Results First Posted
July 11, 2016
Record last verified: 2016-05