Multiple Sclerosis Clinical Trial
Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
Summary
The primary objective of the study is to assess the safety and tolerability of long-term treatment with BIIB019 (Daclizumab High Yield Process; DAC HYP) monotherapy in participants with relapsing remitting multiple sclerosis (RRMS) who completed Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
Secondary objectives of this study in this study population are as follows:
To describe MS-related outcomes, including MS relapse, disability progression, MS lesion formation, and participant-reported impact of MS, following long-term treatment with DAC HYP To assess the long-term immunogenicity of DAC HYP administered by prefilled syringe (PFS) To assess the safety, tolerability, and efficacy of switching to DAC HYP in participants previously on long-term treatment with interferon β-1a (Avonex) in Study 205MS301(NCT01064401).
Full Description
Enrollment will include up to 1600 Participants, this includes approximately 1200 Participants who completed Study 205MS301 (NCT01064401). Additionally, approximately 400 Participants from the other BIIB019 extension studies 205MS203 (NCT01051349) and 205MS302 (NCT01462318) will be eligible to enter Study 205MS303 at Week 144 of Study 205MS303 [Study 205MS301 (NCT01064401), study 205MS203 (NCT01051349) and study 205MS302 (NCT01462318) have been referred to as parent studies in the protocol]. All Participants will receive the same dose of DAC HYP as received in the parent studies; i.e., 150 mg by an SC injection every 4 weeks.
Eligibility Criteria
Key Inclusion Criteria:
Must be a subject currently participating in Study 205MS301 (NCT01064401), or subject currently participating in Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) who has completed End of Study Visit (Week 96 or later).
Women of childbearing potential must 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:
Any subject who permanently discontinued study treatment in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318) prior to the end of the study treatment period, or had an Early Termination visit in Study 205MS301, Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
Any significant change in the subject's medical history that would preclude administration of BIIB019, including laboratory tests or a current clinically significant condition that, in the opinion of the Investigator, would have excluded the subject's participation in Study 205MS301 (NCT01064401), Study 205MS203 (NCT01051349) or Study 205MS302 (NCT01462318).
The Investigator must re review the subject's medical fitness for participation and consider any factors that would preclude treatment in this Study 205MS303.
NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
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There are 220 Locations for this study
Phoenix Arizona, 85013, United States
Phoenix Arizona, 85050, United States
Tucson Arizona, 85704, United States
Little Rock Arkansas, 72205, United States
La Jolla California, 92037, United States
Aurora Colorado, 80045, United States
Centennial Colorado, 80112, United States
Naples Florida, 34102, United States
Pompano Beach Florida, 33060, United States
Atlanta Georgia, 30327, United States
Fort Wayne Indiana, 46804, United States
Indianapolis Indiana, 46202, United States
Kansas City Kansas, 66160, United States
Lexington Kentucky, 40503, United States
Wellesley Massachusetts, 02481, United States
Worcester Massachusetts, 01605, United States
Farmington Hills Michigan, 48334, United States
Lebanon New Hampshire, 03756, United States
Albuquerque New Mexico, 87131, United States
Buffalo New York, 14203, United States
Latham New York, 12110, United States
New York New York, 10016, United States
New York New York, 10065, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28207, United States
Raleigh North Carolina, 27607, United States
Winston-Salem North Carolina, 27103, United States
Dayton Ohio, 45408, United States
Medford Oregon, 97504, United States
Portland Oregon, 97225, United States
Allentown Pennsylvania, 18103, United States
Pittsburgh Pennsylvania, 15213, United States
Cordova Tennessee, 38018, United States
Franklin Tennessee, 37064, United States
Knoxville Tennessee, 37922, United States
Round Rock Texas, 78681, United States
Henrico Virginia, 23226, United States
Tacoma Washington, 98405, United States
Milwaukee Wisconsin, 53215, United States
Ciudad Autónoma de Buenos Aires Buenos Aires, C1015, Argentina
Ciudad Autónoma de Buenos Aires Buenos Aires, C1061, Argentina
Godoy Cruz Mendoza, M5501, Argentina
Rosario Santa Fe, S2000, Argentina
Auchenflower Queensland, 4066, Australia
Heidelberg Victoria, 3084, Australia
Belo Horizonte Minas Gerais, 30150, Brazil
Recife Pernambuco, 52010, Brazil
Porto Alegre Rio Grande Do Sul, 90035, Brazil
Campinas São Paulo, 13083, Brazil
Ribeirão Preto São Paulo, 14049, Brazil
Rio de Janeiro , 20270, Brazil
Rio De Janeiro , 21941, Brazil
Vancouver British Columbia, V6T 2, Canada
Saint Johns Newfoundland and Labrador, A1B 3, Canada
London Ontario, N6A 5, Canada
Ottawa Ontario, K1H 8, Canada
Gatineau Quebec, J9J 0, Canada
Greenfield Park Quebec, J4V 2, Canada
Brno Jihomoravský Kraj, 625 0, Czechia
Brno Jihomoravský Kraj, 656 9, Czechia
Jihlava Kray Vysocina, 586 3, Czechia
Ostrava Moravskoslezský Kraj, 708 5, Czechia
Pardubice Pardubický Kraj, 532 0, Czechia
Praha 10 Praha, 100 3, Czechia
Praha 2 Praha, 128 0, Czechia
Olomouc Severomoravsky Kraj, 775 2, Czechia
Hradec Kralove , 500 0, Czechia
Praha 5 , 150 0, Czechia
Teplice Ústecký Kraj, 415 2, Czechia
Copenhagen , 2100, Denmark
Glostrup , 2600, Denmark
Odense C , 5000, Denmark
Strasbourg Bas-Rhin, 67091, France
Marseille Bouches-du-Rhône, 13385, France
Caen Calvados, 14033, France
Bordeaux Gironde, 33076, France
Toulouse Haute-Garonne, 31059, France
Bobigny Ile-de-France, 93009, France
Nancy Meurthe-et-Moselle, 54000, France
Lille Nord, 59037, France
Amiens Cedex 1 , 80054, France
Paris , 75019, France
Tbilisi , 0179, Georgia
Bad Mergentheim Baden-Württemberg, 97980, Germany
Freiburg Baden-Württemberg, 79106, Germany
Bayreuth Bayern, 95445, Germany
Erlangen Bayern, 91054, Germany
München Bayern, 81675, Germany
Marburg Hessen, 35043, Germany
Rostock Mecklenburg-Vorpommern, 18147, Germany
Dresden Sachsen, 01307, Germany
Bamberg , 96052, Germany
Athens Attiki, 11525, Greece
Thessaloniki Macedonia, 57010, Greece
Athens , 115 2, Greece
Thessaloniki , 546 3, Greece
Miskolc Borsod-Abaúj-Zemplén, 3533, Hungary
Kecskemét Bács-Kiskun, 6000, Hungary
Székesfehérvár Fejer, 8000, Hungary
Balatonfüred , 8230, Hungary
Budapest , 1125, Hungary
Budapest , 1134, Hungary
Budapest , 1145, Hungary
Budapest , 1204, Hungary
Debrecen , 4043, Hungary
Esztergom , 2500, Hungary
Gyor , 9024, Hungary
Miskolc , 3526, Hungary
NyÃregyháza , 4400, Hungary
Hyderabad Andhra Pradesh, 50008, India
Bangalore Karnataka, 56005, India
Trivandrum Kerala, 69501, India
Mumbai Maharashtra, 40001, India
Gurgaon , 12200, India
Dublin , DU04, Ireland
Dublin , DU09, Ireland
Ashkelon , 78278, Israel
Haifa , 31096, Israel
Petah Tikva , 49100, Israel
Safed , 13100, Israel
Genova Liguria, 16132, Italy
Milano Lombardia, 20127, Italy
Padova Veneto, 35128, Italy
Catania , 95123, Italy
Cefalù , 90015, Italy
Roma , 00133, Italy
Roma , 00189, Italy
Distrito Federal , 03310, Mexico
Distrito Federal , 06700, Mexico
Chisinau , MD 20, Moldova, Republic of
Chisinau , MD 20, Moldova, Republic of
Bydgoszcz Kujawsko-pomorskie, 85-68, Poland
Lublin Lubelskie, 20-95, Poland
Lodz Lódzkie, 90-32, Poland
Kraków Malopolskie, 31-50, Poland
Kraków Malopolskie, 31-63, Poland
Warszawa Mazowieckie, 00-90, Poland
Warszawa Mazowieckie, 02-09, Poland
Warszawa Mazowieckie, 02-50, Poland
Warszawa Mazowieckie, 02-95, Poland
Warszawa Mazowieckie, 04-74, Poland
Bialystok Podlaskie, 15-27, Poland
Bialystok Podlaskie, 15-40, Poland
Gdansk Pomorskie, 80-29, Poland
Gdansk Pomorskie, 80-95, Poland
Katowice Slaskie, 40-59, Poland
Katowice Slaskie, 40-65, Poland
Katowice Slaskie, 40-75, Poland
Kielce Swietokrzyskie, 25-72, Poland
Olsztyn Warminsko-mazurskie, 10-44, Poland
Plewiska Wielkopolskie, 62-06, Poland
Poznan Wielkopolskie, 60-35, Poland
Poznan Wielkopolskie, 60-63, Poland
Poznan Wielkopolskie, 61-85, Poland
Szczecin Zachodniopomorskie, 70-11, Poland
Szczecin Zachodniopomorskie, 71-25, Poland
Gdansk , 80-80, Poland
Grudziadz , 86-30, Poland
Katowice , 40-68, Poland
Katowice , 40-74, Poland
Olsztyn , 10-56, Poland
Cluj- Napoca Cluj, 40001, Romania
Târgu Mures Mures, 54013, Romania
Timisoara Timis, 30073, Romania
Bucharest , 01146, Romania
Iasi , 70065, Romania
Yaroslavl Yaroslavlr, 15003, Russian Federation
Kazan , 42002, Russian Federation
Kemerovo , 65006, Russian Federation
Krasnoyarsk , 66002, Russian Federation
Moscow , 12701, Russian Federation
Moscow , 12912, Russian Federation
Nizhny Novgorod , 60300, Russian Federation
Nizhny Novgorod , 60315, Russian Federation
Novosibirsk , 63008, Russian Federation
Omsk , 64404, Russian Federation
Perm , 61499, Russian Federation
Samara , 44309, Russian Federation
Smolensk , 21401, Russian Federation
St. Petersburg , 19404, Russian Federation
St. Petersburg , 19429, Russian Federation
St. Petersburg , 19737, Russian Federation
Tyumen , 62500, Russian Federation
Ufa , 45000, Russian Federation
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Nis , 18000, Serbia
Novi Sad , 21000, Serbia
Badalona Barcelona, 08035, Spain
Cordoba Córdoba, 14008, Spain
Madrid Madrid, Communidad Delaware, 28040, Spain
Girona , 17007, Spain
l'Hospitalet de Llobregat , 08907, Spain
Sevilla , 41071, Spain
Malmö Skane, 205 0, Sweden
Stockholm Sodermanlands Lan, 141 8, Sweden
Stockholm Sodermanlands Lan, 182 8, Sweden
Göteborg Vastra Gotalands Lan, 413 4, Sweden
Stockholm , 171 7, Sweden
Basel Basel-Stadt (de), 4031, Switzerland
Chernivtsi Chernivets'ka Oblast, 58018, Ukraine
Dnipropetrovsk Dnipropetrovs'ka Oblast', 49027, Ukraine
Donetsk Donets'ka Oblast', 83003, Ukraine
Kharkiv Kharkivs'ka Oblast', 61068, Ukraine
Kyiv Kyïv, 02125, Ukraine
Kyiv Kyïv, 03110, Ukraine
Kyiv Kyïv, 04060, Ukraine
Odesa Odes'ka Oblast, 65025, Ukraine
Poltava Poltavs'ka Oblast, 36011, Ukraine
Vinnytsia Vinnyts'ka Oblast', 21005, Ukraine
Zaporizhzhia Zaporiz'ka Oblast', 69035, Ukraine
Zaporizhzhia Zaporizhia Oblast, 69600, Ukraine
Kharkiv , 61103, Ukraine
Plymouth Devon, PL6 8, United Kingdom
Edinburgh Edinburgh, City Of, EH4 2, United Kingdom
Brighton , BN2 5, United Kingdom
London , E1 2A, United Kingdom
London , SE5 9, United Kingdom
London , W6 8R, United Kingdom
London , WC1N , United Kingdom
Nottingham , NG7 2, United Kingdom
Sheffield , S10 2, United Kingdom
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