Relapsing-Remitting Multiple SclerosisPhase 3(DECIDE)NCT01064401

Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis

A Phase 3 study testing BIIB019 (Daclizumab High Yield Process) and Interferon beta-1a in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 228 sites in 28 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Relapsing-Remitting Multiple Sclerosis
What is being tested?: BIIB019 (Daclizumab High Yield Process) and Interferon beta-1a
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,841 participants
Where: 228 sitesin 28 countries
Study dates: May 2010to Jul 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

Show all 15Show fewer

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.

Trial locations and contacts

228 sites in 28 countries.

Country

City, postcode or hospital

228 sites in 28 countries

United States46 sites

Research Site
Albuquerque, New Mexico
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Allentown, Pennsylvania
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Atlanta, Georgia
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Aurora, Colorado
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Baltimore, Maryland
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Buffalo, New York
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Burlington, Vermont
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Charlotte, North Carolina
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Clinton Township, Michigan
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Des Moines, Iowa
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Evanston, Illinois
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Fort Wayne, Indiana
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Franklin, Tennessee
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Gilbert, Arizona
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Indianapolis, Indiana
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Kansas City, Kansas
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Kirkland, Washington
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Knoxville, Tennessee
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La Jolla, California
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Latham, New York
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Lebanon, New Hampshire
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Lexington, Kentucky
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Little Rock, Arkansas
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Medford, Oregon
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Milwaukee, Wisconsin
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Naples, Florida
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New Brunswick, New Jersey
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New York, New York
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pittsburgh, Pennsylvania
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Pompano Beach, Florida
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Portland, Oregon
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Providence, Rhode Island
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Raleigh, North Carolina
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Rochester, New York
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Salt Lake City, Utah
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Seattle, Washington
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Springfield, Massachusetts
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St Louis, Missouri
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St. Petersburg, Florida
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Sunrise, Florida
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Tacoma, Washington
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Tucson, Arizona
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Winston-Salem, North Carolina
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Worchester, Massachusetts

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Russia16 sites

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Chelyabinsk
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Kaluga
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Kazan', Povolje-Tatarstan
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Kemerovo
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Krasnoyarsk
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Moscow
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Nizhny Novgorod
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Novosibirsk
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Perm
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Saint Petersburg
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Smolensk
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Tomsk
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Tyumen
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Ufa
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Yaroslavl, Yaroslavlr
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Yekaterinburg, Ural

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Germany15 sites

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Bad Mergentheim, Baden-Wurttemberg
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Bamberg, Bavaria
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Bayreuth, Bavaria
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Berlin, State of Berlin
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Cologne, North Rhine-Westphalia
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Dresden, Saxony
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Essen, North Rhine-Westphalia
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Freiburg im Breisgau, Baden-Wurttemberg
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Hamburg, Free and Hanseatic City of Hamburg
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Marburg, Hesse
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München, Bavaria
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Münster, North Rhine-Westphalia
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Neuburg an der Donau, Bavaria
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Trier, Rhineland-Palatinate
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Tübingen

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Poland15 sites

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Bialystok, Podlaskie Voivodeship
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship
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Bydgoszczas
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Gdansk, Pomeranian Voivodeship
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Grudziądz, Kuyavian-Pomeranian Voivodeship
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Katowice, Silesian Voivodeship
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Kielce, Swietokrzycie
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Krakow, Lesser Poland Voivodeship
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Lódz, Łódź Voivodeship
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Lublin, Lower Silesian Voivodeship
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Olsztyn, Warmian-Masurian Voivodeship
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Plewiska
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Poznan, Greater Poland Voivodeship
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Szczecin, West Pomeranian Voivodeship
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Warsaw, Masovian Voivodeship

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France14 sites

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Amiens, Picardie
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Bobigny, Île-de-France Region
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Bourdeaux
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Caen, Basse-normandie
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Dijon
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Lille
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Lomme
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Lyon, Auvergne-Rhône-Alpes
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Marseille
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Nancy
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Nice, Provence-Alpes-Côte d'Azur Region
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Paris, Île-de-France Region
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Strasbourg, Alsace
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Toulouse

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Canada10 sites

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Calgary, Alberta
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Edmonton, Alberta
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Gatineau, Quebec
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Greenfield Park, Quebec
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London, Ontario
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Montreal, Quebec
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Ottawa, Ontario
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Regina, Saskatchewan
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St. John's, Newfoundland and Labrador
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Vancouver, British Columbia

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Czechia10 sites

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Brno, South Bohemian Region
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Brno
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Havířov, Severomoravksy Krav
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Hradec Králové
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Jihlava, Vysocina
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Jihlava
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Olomouc, Olomouc Region
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Ostrava
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Pardubice
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Prague, Prague

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Italy10 sites

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Bari, Bari
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Cagliari, Cagliari
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Catania, Catania
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Cefalù, PA
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Florence
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Genova, Genova
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Milan
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Orbassano, Torino
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Padova
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Roma, Roma

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United Kingdom9 sites

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Brighton
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Bristol
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Edinburgh
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London
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New Castle Upon Tyne
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Nottingham
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Romford
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Salford
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Sheffield

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Brazil8 sites

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Belo Horizonte, Estado de Bahia
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Brasília, Federal District
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Campinas, São Paulo
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Porto Alegre, Rio Grande
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Recife, Pernambuco
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Ribeirão Preto, São Paulo
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Rio de Janeiro, Rio de Janeiro
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São Paulo, Rio Grande

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Hungary7 sites

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Budapest, Budapest
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Esztergom
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Győr, Győr-Moson-Sopron
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Miskolc
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Nyíregyháza
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Székesfehérvár, Fejér
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Veszprém

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India7 sites

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Bangalore, Karnataka
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Delhi, Dwivdee
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Hyderabad, Andhra Pradesh
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Mumbai, Maharashtra
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Nagpur, Maharashtra
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New Delhi
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Trivandrum, Kerala

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Israel7 sites

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Ashkelon, Ashqelon
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Beersheba
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Haifa
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Kfar Saba
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Petah Tikva, Petah Tiqwa
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Tzfat
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Tzrifin, Beer Yaakov

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Ukraine7 sites

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Dnipro
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Kharkiv
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Kyviv
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Odesa
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Poltava
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Vinnitsa
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Zaporizhzhya

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Australia6 sites

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Auchenflower, Queensland
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Camperdown, New South Wales
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Fitzroy, Victoria
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Heidelberg West, Victoria
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New Lambton Heights, New South Wales
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Woodville, South Australia

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Spain6 sites

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Barcelona, Barcelona
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Córdoba, Cordoba
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Girona
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L'Hospitalet de Llobregat, Barcelona
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Madrid, Madrid
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Seville, Sevilla

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Finland5 sites

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Helsinki
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Oulu, Oulu
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Seinäjoki
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Tampere, Western Finalnd
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Turku

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Romania5 sites

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Bucurest, Bucharest
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Cluj-Napoca, Cluj
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Iași
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Târgu Mures
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Timișoara, Timiș County

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Denmark4 sites

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Aarhus
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Copenhagen
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Glostrup Municipality
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Odense C

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Serbia4 sites

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Belgrade
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Kragujevac
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Niš
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Novi Sad

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Sweden4 sites

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Gothenburg
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Linköping
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Malmö
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Stockholm

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Argentina3 sites

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Ciudad Autónoma de Buenos Aires, Buenos Aires
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Godoy Cruz, Mendoza Province
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Rosario, Santa Fe Province

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Greece3 sites

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Athens, Attica
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Heraklion, Crete
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Thessaloniki, Macedoni

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Mexico2 sites

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Guadalajara, Jalisco
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Mexico City, Mexico City

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Switzerland2 sites

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Basel, Basel
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Lugano

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Georgia1 site

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Tbilisi

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Ireland1 site

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Dublin, Dublin

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Moldova1 site

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Chisinau

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About this study

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

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.

Conditions: Relapsing-Remitting Multiple Sclerosis
Being tested: BIIB019 (Daclizumab High Yield Process), Interferon beta-1a Placebo, Interferon beta-1a, Daclizumab High Yield Process Placebo
Medical subject headings: Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BIIB019 (Daclizumab High Yield Process)Biological
Also called DAC HYP
Daclizumab High Yield Process for subcutaneous injection
Interferon beta-1a PlaceboDrug
Placebo to interferon beta-1a intramuscular injection
Interferon beta-1aBiological
Also called Avonex, IFN β-1a
Interferon beta-1a for intramuscular injection
Daclizumab High Yield Process PlaceboDrug
Placebo to Daclizumab High Yield Process subcutaneous injection

Study groups in NCT01064401
Study group	Role	What they receive
Daclizumab High Yield Process 150 mg SC	Experimental	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 Receives: Biological: BIIB019 (Daclizumab High Yield Process); Drug: Interferon beta-1a Placebo
IFN β-1a 30 µg IM	Active comparator	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 Receives: Biological: Interferon beta-1a; Drug: Daclizumab High Yield Process Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Up to 144 weeks

Secondary outcomes (4)

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.
Measured: up to 96 weeks
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.
Measured: Baseline through 144 weeks
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.
Measured: 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
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.
Measured: Baseline and 96 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2010Jul 2014

First posted8 Feb 2010 (estimated)
Study startMay 2010
Primary completionMar 2014
Study completionJul 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Relapsing-Remitting Multiple SclerosisStudies of the same condition, open and under way.
More trials run by BiogenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,841 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01064401
Sponsor's protocol ID: 205MS301
Other IDs: 2009-012500-11, 2009
Acronym: (DECIDE)
Status last verified: May 2016
First submitted: 26 Jan 2010
Last updated: 11 Jul 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 37652990
Castrogiovanni 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.
PubMed 37072219
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.
PubMed 28984179
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.
PubMed 28485186
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.
PubMed 28104250
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.
PubMed 27251051
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.
PubMed 26444729

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01064401
Acronym / sponsor ID: (DECIDE) / 205MS301
Conditions: Relapsing-Remitting Multiple Sclerosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,841 participants (actual)
Lead sponsor: BiogenIndustry (pharma, biotech, devices)
Collaborators: AbbVie
Study start: May 2010
Primary completion: Mar 2014 (actual)
Study completion: Jul 2014 (actual)
First posted: 8 Feb 2010 (estimated)
Results: Posted 11 Jul 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Daclizumab High Yield Process 150 mg SC	Experimental	Biological: BIIB019 (Daclizumab High Yield Process), Drug: Interferon beta-1a PlaceboDaclizumab 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 comparator	Biological: Interferon beta-1a, Drug: Daclizumab High Yield Process PlaceboInterferon 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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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 (15 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BIIB019 (Daclizumab High Yield Process)Also: DAC HYPDaclizumab High Yield Process for subcutaneous injection	Biological	Daclizumab High Yield Process 150 mg SC
Interferon beta-1a PlaceboPlacebo to interferon beta-1a intramuscular injection	Drug	Daclizumab High Yield Process 150 mg SC
Interferon beta-1aAlso: Avonex, IFN β-1aInterferon beta-1a for intramuscular injection	Biological	IFN β-1a 30 µg IM
Daclizumab High Yield Process PlaceboPlacebo to Daclizumab High Yield Process subcutaneous injection	Drug	IFN β-1a 30 µg IM

Primary outcome

Adjusted Annualized Relapse Rate (ARR)
Time frame: Up to 144 weeks
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.

4 secondary outcomes

Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
Time frame: up to 96 weeks
Proportion of Participants With Sustained Disability Progression at 144 Weeks
Time frame: Baseline through 144 weeks
Proportion of Participants Relapse-free at Week 144
Time frame: 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
Time frame: Baseline and 96 weeks

Results and safety

Results posted to the registry on 11 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Interferon Beta-1a	922	694
Daclizumab High Yield Process	919	724

Primary outcome: Adjusted Annualized Relapse Rate (ARR)

Time frame: Up to 144 weeks. Number (95% Confidence Interval). Unit: relapses per person-years

Measure	Interferon Beta-1a n = 392	Daclizumab High Yield Process n = 260
Value	0.393 (0.353 to 0.438)	0.216 (0.191 to 0.244)

Interferon Beta-1a vs Daclizumab High Yield Process: Rate Ratio: 0.550 (95% CI 0.469 to 0.645), p < 0.0001, Negative Binomial Regression
Interferon Beta-1a vs Daclizumab High Yield Process: Percent Reduction: 45.0 (95% CI 35.5 to 53.1)

Population analysed: participants with a relapse

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: All events were collected from Baseline through Week 164 (end of Post-dosing period).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IFN Beta-1a 30 mcg	194 of 922 (21%)	783 of 922 (84.9%)	Not reported
DAC HYP 150 mg	221 of 919 (24%)	731 of 919 (79.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37652990Loomis 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.
Derived from this study: PubMed 37072219Castrogiovanni 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.
Derived from this study: PubMed 28984179Cohan 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.
Derived from this study: PubMed 28485186Benedict 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.
Derived from this study: PubMed 28104250Liu 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.
Derived from this study: PubMed 27251051Krueger 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.
Derived from this study: PubMed 26444729Kappos 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Biogen

228 sites in 28 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BIIB019 (Daclizumab High Yield Process) and Interferon beta-1a in people with Relapsing-Remitting Multiple Sclerosis, run by Biogen at 228 sites in 28 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 228 sites in United States, Russia, Germany, Poland, France and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adjusted Annualized Relapse Rate (ARR) (time frame: Up to 144 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01064401, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.