Multiple Sclerosis Clinical Trial
Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis
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.
Eligibility Criteria
Key Inclusion Criteria:
Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS
Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive
Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment
Key Exclusion Criteria:
Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg
History of treatment with Daclizumab High Yield Process (Dac HYP)
History of malignancy
History of severe allergic or anaphylactic reactions
Known hypersensitivity to study drugs or their excipients
History of abnormal laboratory results indicative of any significant disease
History of human immunodeficiency virus (HIV) or other immunodeficient conditions
History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
Exposure to varicella zoster virus within 21 days before screening
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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There is 1 Location for this study
Gilbert Arizona, , United States
Phoenix Arizona, , United States
Tucson Arizona, , United States
Little Rock Arkansas, , United States
La Jolla California, , United States
Aurora Colorado, , United States
Naples Florida, , United States
Pompano Beach Florida, , United States
St. Petersburg Florida, , United States
Sunrise Florida, , United States
Atlanta Georgia, , United States
Evanston Illinois, , United States
Fort Wayne Indiana, , United States
Indianapolis Indiana, , United States
Des Moines Iowa, , United States
Kansas City Kansas, , United States
Lexington Kentucky, , United States
Baltimore Maryland, , United States
Springfield Massachusetts, , United States
Worchester Massachusetts, , United States
Clinton Township Michigan, , United States
Saint Louis Missouri, , United States
Lebanon New Hampshire, , United States
New Brunswick New Jersey, , United States
Albuquerque New Mexico, , United States
Buffalo New York, , United States
Latham New York, , United States
New York New York, , United States
Rochester New York, , United States
Charlotte North Carolina, , United States
Raleigh North Carolina, , United States
Winston Salem North Carolina, , United States
Medford Oregon, , United States
Portland Oregon, , United States
Allentown Pennsylvania, , United States
Philadelphia Pennsylvania, , United States
Pittsburg Pennsylvania, , United States
Providence Rhode Island, , United States
Franklin Tennessee, , United States
Knoxville Tennessee, , United States
Salt Lake City Utah, , United States
Burlington Vermont, , United States
Kirkland Washington, , United States
Seattle Washington, , United States
Tacoma Washington, , United States
Milwaukee Wisconsin, , United States
Ciudad Autónoma de Buenos Aires Buenos Aires, , Argentina
Godoy Cruz Mendoza, , Argentina
Rosario Santa Fe, , Argentina
Camperdown New South Wales, , Australia
New Lambton Heights New South Wales, , Australia
Auchenflower Queensland, , Australia
Woodville South Australia, , Australia
Fitzroy Victoria, , Australia
Heidelberg West Victoria, , Australia
Belo Horizonte Bahia, , Brazil
Brasilia Distrito Federal, , Brazil
Recife Pernambuco, , Brazil
Porto Alegre Rio Grande, , Brazil
Sao Paulo Rio Grande, , Brazil
Campinas Sao Paulo, , Brazil
Ribeirão Preto Sao Paulo, , Brazil
Rio de Janeiro , , Brazil
Calgary Alberta, , Canada
Edmonton Alberta, , Canada
Vancouver British Columbia, , Canada
Saint John Newfoundland and Labrador, , Canada
London Ontario, , Canada
Ottawa Ontario, , Canada
Gatineau Quebec, , Canada
Greenfield Park Quebec, , Canada
Montréal Quebec, , Canada
Regina Saskatchewan, , Canada
Brno Jihocesky Kraj, , Czech Republic
Jihlava Kraj Vysocina, , Czech Republic
Olomouc Olomoucký kraj, , Czech Republic
Praha 10 Praha, , Czech Republic
Praha 2 Praha, , Czech Republic
Havirov Severomoravksy Krav, , Czech Republic
Brno , , Czech Republic
Hradec Kralove , , Czech Republic
Jihlava , , Czech Republic
Ostrava , , Czech Republic
Pardubice , , Czech Republic
Copenhagen , , Denmark
Glostrup , , Denmark
Odense C , , Denmark
Ã…rhus , , Denmark
Tampere Western Finalnd, , Finland
Helsinki , , Finland
Oulu , , Finland
Seinäjoki , , Finland
Turku , , Finland
Strasbourg Alsace, , France
Caen Cedex 5 Basse-normandie, , France
Bobigny Ile-de-france, , France
Paris Cedex 5 Ile-de-france, , France
Paris Ile-de-france, , France
Amiens Picardie, , France
Nice Provence Alpes Cote D'azur, , France
Lyon Rhone-alpes, , France
Bourdeaux , , France
Dijon , , France
Lille , , France
Lomme , , France
Marseille Cedex 9 , , France
Nancy , , France
Toulouse Cedex 3 , , France
Tbilisi , , Georgia
Freiburg Baden-wuerttemberg, , Germany
Bad Mergentheim Baden-Wurttemberg, , Germany
Bamberg Bayern, , Germany
Bayreuth Bayern, , Germany
München Bayern, , Germany
Neuburg an der Donau Bayern, , Germany
Marburg Hessen, , Germany
Essen Nordrhein Westfalen, , Germany
Koln Nordrhein Westfalen, , Germany
Munster Nordrhein-Westfalen, , Germany
Trier Rheinland-Pfalz, , Germany
Dresden Sachsen, , Germany
Berlin , , Germany
Hamburg , , Germany
Tübingen , , Germany
Athens Attica, , Greece
Heraklion Crete, , Greece
Thessaloniki Macedoni, , Greece
Székesfehérvár Fejer, , Hungary
Gyor Gyor-moson-sopron, , Hungary
Budapest , , Hungary
Esztergom , , Hungary
Miskolc , , Hungary
NyÃregyháza , , Hungary
Veszprém , , Hungary
Hyderabad Andhra Pradesh, , India
Delhi Dwivdee, , India
Bangalore Karnataka, , India
Trivandrum Kerala, , India
Mumbai Maharashtra, , India
Nagpur Maharashtra, , India
New Delhi , , India
Dublin , , Ireland
Ashkelon Ashqelon, , Israel
Tzrifin Beer Yaakov, , Israel
Petach Tikva Petah Tiqwa, , Israel
Beer-Sheva , , Israel
Haifa , , Israel
Kfar Saba , , Israel
Tzfat , , Israel
Cefalù PA, , Italy
Orbassano Torino, , Italy
Bari , , Italy
Cagliari , , Italy
Catania , , Italy
Firenze , , Italy
Genova , , Italy
Milano , , Italy
Padova , , Italy
Roma , , Italy
Mexico Distrito Federal, , Mexico
Guadalajara Jalisco, , Mexico
Chisinau , , Moldova, Republic of
Lublin Dolnoslaskie, , Poland
Bydgoszcz Kujawsko-pomorskie, , Poland
Grudziadz Kujawsko-pomorskie, , Poland
Lódz Lodzkie, , Poland
Kraków Malopolskie, , Poland
Warszawa Mazowieckie, , Poland
Bialystok Podlaskie, , Poland
Gdansk Pomorskie, , Poland
Katowice Slaskie, , Poland
Kielce Swietokrzycie, , Poland
Olsztyn Warminsko-mazurskie, , Poland
Poznan Wielkopolskie, , Poland
Szczecin Zachodniopomorskie, , Poland
Bydgoszczas , , Poland
Plewiska , , Poland
Bucurest Bucuresti, , Romania
Cluj-Napoca Cluj, , Romania
Timisoara Timis, , Romania
Iasi , , Romania
Târgu Mures , , Romania
Kazan Povolje-Tatarstan, , Russian Federation
Ekaterinburg Ural, , Russian Federation
Yaroslavl Yaroslavlr, , Russian Federation
Chelyabinsk , , Russian Federation
Kaluga , , Russian Federation
Kemerovo , , Russian Federation
Krasnoyarsk , , Russian Federation
Moscow , , Russian Federation
Nizhny Novgorod , , Russian Federation
Novosibirsk , , Russian Federation
Perm , , Russian Federation
Saint Petersburg , , Russian Federation
Smolensk , , Russian Federation
Tomsk , , Russian Federation
Tumen , , Russian Federation
Ufa , , Russian Federation
Belgrade , , Serbia
Kragujevac , , Serbia
Nis , , Serbia
Novi Sad , , Serbia
L´Hospitalet de Llobregat Barcelona, , Spain
Barcelona , , Spain
Cordoba , , Spain
Girona , , Spain
Madrid , , Spain
Sevilla , , Spain
Göteborg , , Sweden
Linköping , , Sweden
Malmö , , Sweden
Stockholm , , Sweden
Basel , , Switzerland
Lugano , , Switzerland
Dnepropetrovsk , , Ukraine
Kharkiv , , Ukraine
Kyviv , , Ukraine
Odessa , , Ukraine
Poltava , , Ukraine
Vinnitsa , , Ukraine
Zaporozhye , , Ukraine
Brighton , , United Kingdom
Bristol , , United Kingdom
Edinburgh , , United Kingdom
London , , United Kingdom
New Castle Upon Tyne , , United Kingdom
Nottingham , , United Kingdom
Romford , , United Kingdom
Salford , , United Kingdom
Sheffield , , United Kingdom
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