Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
NCT ID: NCT01064401
Last Updated: 2016-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1841 participants
INTERVENTIONAL
2010-05-31
2014-07-31
Brief Summary
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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.
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Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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 β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process for subcutaneous injection
Interferon beta-1a Placebo
Placebo to interferon beta-1a intramuscular injection
IFN β-1a 30 µg IM
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
Interferon beta-1a
Interferon beta-1a for intramuscular injection
Daclizumab High Yield Process Placebo
Placebo to Daclizumab High Yield Process subcutaneous injection
Interventions
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BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process for subcutaneous injection
Interferon beta-1a Placebo
Placebo to interferon beta-1a intramuscular injection
Interferon beta-1a
Interferon beta-1a for intramuscular injection
Daclizumab High Yield Process Placebo
Placebo to Daclizumab High Yield Process subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
55 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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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, City state of 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
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2009-012500-11
Identifier Type: -
Identifier Source: secondary_id
205MS301
Identifier Type: -
Identifier Source: org_study_id
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