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).

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1501

Study ID:

NCT01797965

Recruitment Status:

Terminated

Sponsor:

Biogen

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There are 220 Locations for this study

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Phoenix Arizona, 85013, United States
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Phoenix Arizona, 85050, United States
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Tucson Arizona, 85704, United States
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Little Rock Arkansas, 72205, United States
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La Jolla California, 92037, United States
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Aurora Colorado, 80045, United States
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Centennial Colorado, 80112, United States
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Naples Florida, 34102, United States
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Pompano Beach Florida, 33060, United States
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Atlanta Georgia, 30327, United States
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Fort Wayne Indiana, 46804, United States
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Indianapolis Indiana, 46202, United States
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Kansas City Kansas, 66160, United States
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Lexington Kentucky, 40503, United States
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Wellesley Massachusetts, 02481, United States
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Worcester Massachusetts, 01605, United States
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Farmington Hills Michigan, 48334, United States
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Lebanon New Hampshire, 03756, United States
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Albuquerque New Mexico, 87131, United States
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Buffalo New York, 14203, United States
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Latham New York, 12110, United States
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New York New York, 10016, United States
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New York New York, 10065, United States
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Rochester New York, 14642, United States
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Charlotte North Carolina, 28207, United States
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Raleigh North Carolina, 27607, United States
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Winston-Salem North Carolina, 27103, United States
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Dayton Ohio, 45408, United States
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Medford Oregon, 97504, United States
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Portland Oregon, 97225, United States
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Allentown Pennsylvania, 18103, United States
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Pittsburgh Pennsylvania, 15213, United States
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Cordova Tennessee, 38018, United States
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Franklin Tennessee, 37064, United States
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Knoxville Tennessee, 37922, United States
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Round Rock Texas, 78681, United States
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Henrico Virginia, 23226, United States
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Tacoma Washington, 98405, United States
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Milwaukee Wisconsin, 53215, United States
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Ciudad Autónoma de Buenos Aires Buenos Aires, C1015, Argentina
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Ciudad Autónoma de Buenos Aires Buenos Aires, C1061, Argentina
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Godoy Cruz Mendoza, M5501, Argentina
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Rosario Santa Fe, S2000, Argentina
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Auchenflower Queensland, 4066, Australia
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Heidelberg Victoria, 3084, Australia
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Belo Horizonte Minas Gerais, 30150, Brazil
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Recife Pernambuco, 52010, Brazil
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Porto Alegre Rio Grande Do Sul, 90035, Brazil
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Campinas São Paulo, 13083, Brazil
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Ribeirão Preto São Paulo, 14049, Brazil
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Rio de Janeiro , 20270, Brazil
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Rio De Janeiro , 21941, Brazil
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Vancouver British Columbia, V6T 2, Canada
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Saint Johns Newfoundland and Labrador, A1B 3, Canada
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London Ontario, N6A 5, Canada
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Ottawa Ontario, K1H 8, Canada
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Gatineau Quebec, J9J 0, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Brno Jihomoravský Kraj, 625 0, Czechia
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Brno Jihomoravský Kraj, 656 9, Czechia
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Jihlava Kray Vysocina, 586 3, Czechia
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Ostrava Moravskoslezský Kraj, 708 5, Czechia
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Pardubice Pardubický Kraj, 532 0, Czechia
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Praha 10 Praha, 100 3, Czechia
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Praha 2 Praha, 128 0, Czechia
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Olomouc Severomoravsky Kraj, 775 2, Czechia
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Hradec Kralove , 500 0, Czechia
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Praha 5 , 150 0, Czechia
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Teplice Ústecký Kraj, 415 2, Czechia
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Copenhagen , 2100, Denmark
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Glostrup , 2600, Denmark
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Odense C , 5000, Denmark
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Strasbourg Bas-Rhin, 67091, France
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Marseille Bouches-du-Rhône, 13385, France
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Caen Calvados, 14033, France
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Bordeaux Gironde, 33076, France
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Toulouse Haute-Garonne, 31059, France
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Bobigny Ile-de-France, 93009, France
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Nancy Meurthe-et-Moselle, 54000, France
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Lille Nord, 59037, France
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Amiens Cedex 1 , 80054, France
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Paris , 75019, France
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Tbilisi , 0179, Georgia
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Bad Mergentheim Baden-Württemberg, 97980, Germany
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Freiburg Baden-Württemberg, 79106, Germany
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Bayreuth Bayern, 95445, Germany
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Erlangen Bayern, 91054, Germany
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München Bayern, 81675, Germany
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Marburg Hessen, 35043, Germany
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Rostock Mecklenburg-Vorpommern, 18147, Germany
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Dresden Sachsen, 01307, Germany
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Bamberg , 96052, Germany
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Athens Attiki, 11525, Greece
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Thessaloniki Macedonia, 57010, Greece
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Athens , 115 2, Greece
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Thessaloniki , 546 3, Greece
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Miskolc Borsod-Abaúj-Zemplén, 3533, Hungary
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Kecskemét Bács-Kiskun, 6000, Hungary
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Székesfehérvár Fejer, 8000, Hungary
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Balatonfüred , 8230, Hungary
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Budapest , 1125, Hungary
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Budapest , 1134, Hungary
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Budapest , 1145, Hungary
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Budapest , 1204, Hungary
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Debrecen , 4043, Hungary
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Esztergom , 2500, Hungary
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Gyor , 9024, Hungary
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Miskolc , 3526, Hungary
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Nyíregyháza , 4400, Hungary
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Hyderabad Andhra Pradesh, 50008, India
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Bangalore Karnataka, 56005, India
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Trivandrum Kerala, 69501, India
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Mumbai Maharashtra, 40001, India
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Gurgaon , 12200, India
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Dublin , DU04, Ireland
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Dublin , DU09, Ireland
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Ashkelon , 78278, Israel
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Haifa , 31096, Israel
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Petah Tikva , 49100, Israel
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Safed , 13100, Israel
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Genova Liguria, 16132, Italy
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Milano Lombardia, 20127, Italy
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Padova Veneto, 35128, Italy
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Catania , 95123, Italy
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Cefalù , 90015, Italy
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Roma , 00133, Italy
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Roma , 00189, Italy
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Distrito Federal , 03310, Mexico
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Distrito Federal , 06700, Mexico
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Chisinau , MD 20, Moldova, Republic of
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Chisinau , MD 20, Moldova, Republic of
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Bydgoszcz Kujawsko-pomorskie, 85-68, Poland
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Lublin Lubelskie, 20-95, Poland
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Lodz Lódzkie, 90-32, Poland
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Kraków Malopolskie, 31-50, Poland
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Kraków Malopolskie, 31-63, Poland
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Warszawa Mazowieckie, 00-90, Poland
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Warszawa Mazowieckie, 02-09, Poland
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Warszawa Mazowieckie, 02-50, Poland
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Warszawa Mazowieckie, 02-95, Poland
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Warszawa Mazowieckie, 04-74, Poland
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Bialystok Podlaskie, 15-27, Poland
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Bialystok Podlaskie, 15-40, Poland
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Gdansk Pomorskie, 80-29, Poland
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Gdansk Pomorskie, 80-95, Poland
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Katowice Slaskie, 40-59, Poland
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Katowice Slaskie, 40-65, Poland
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Katowice Slaskie, 40-75, Poland
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Kielce Swietokrzyskie, 25-72, Poland
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Olsztyn Warminsko-mazurskie, 10-44, Poland
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Plewiska Wielkopolskie, 62-06, Poland
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Poznan Wielkopolskie, 60-35, Poland
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Poznan Wielkopolskie, 60-63, Poland
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Poznan Wielkopolskie, 61-85, Poland
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Szczecin Zachodniopomorskie, 70-11, Poland
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Szczecin Zachodniopomorskie, 71-25, Poland
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Gdansk , 80-80, Poland
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Grudziadz , 86-30, Poland
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Katowice , 40-68, Poland
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Katowice , 40-74, Poland
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Olsztyn , 10-56, Poland
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Cluj- Napoca Cluj, 40001, Romania
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Târgu Mures Mures, 54013, Romania
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Timisoara Timis, 30073, Romania
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Bucharest , 01146, Romania
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Iasi , 70065, Romania
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Yaroslavl Yaroslavlr, 15003, Russian Federation
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Kazan , 42002, Russian Federation
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Kemerovo , 65006, Russian Federation
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Krasnoyarsk , 66002, Russian Federation
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Moscow , 12701, Russian Federation
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Moscow , 12912, Russian Federation
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Nizhny Novgorod , 60300, Russian Federation
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Nizhny Novgorod , 60315, Russian Federation
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Novosibirsk , 63008, Russian Federation
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Omsk , 64404, Russian Federation
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Perm , 61499, Russian Federation
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Samara , 44309, Russian Federation
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Smolensk , 21401, Russian Federation
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St. Petersburg , 19404, Russian Federation
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St. Petersburg , 19429, Russian Federation
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St. Petersburg , 19737, Russian Federation
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Tyumen , 62500, Russian Federation
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Ufa , 45000, Russian Federation
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Belgrade , 11000, Serbia
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Kragujevac , 34000, Serbia
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Nis , 18000, Serbia
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Novi Sad , 21000, Serbia
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Badalona Barcelona, 08035, Spain
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Cordoba Córdoba, 14008, Spain
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Madrid Madrid, Communidad Delaware, 28040, Spain
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Girona , 17007, Spain
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l'Hospitalet de Llobregat , 08907, Spain
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Sevilla , 41071, Spain
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Malmö Skane, 205 0, Sweden
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Stockholm Sodermanlands Lan, 141 8, Sweden
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Stockholm Sodermanlands Lan, 182 8, Sweden
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Göteborg Vastra Gotalands Lan, 413 4, Sweden
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Stockholm , 171 7, Sweden
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Basel Basel-Stadt (de), 4031, Switzerland
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Chernivtsi Chernivets'ka Oblast, 58018, Ukraine
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Dnipropetrovsk Dnipropetrovs'ka Oblast', 49027, Ukraine
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Donetsk Donets'ka Oblast', 83003, Ukraine
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Kharkiv Kharkivs'ka Oblast', 61068, Ukraine
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Kyiv Kyïv, 02125, Ukraine
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Kyiv Kyïv, 03110, Ukraine
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Kyiv Kyïv, 04060, Ukraine
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Odesa Odes'ka Oblast, 65025, Ukraine
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Poltava Poltavs'ka Oblast, 36011, Ukraine
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Vinnytsia Vinnyts'ka Oblast', 21005, Ukraine
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Zaporizhzhia Zaporiz'ka Oblast', 69035, Ukraine
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Zaporizhzhia Zaporizhia Oblast, 69600, Ukraine
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Kharkiv , 61103, Ukraine
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Plymouth Devon, PL6 8, United Kingdom
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Edinburgh Edinburgh, City Of, EH4 2, United Kingdom
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Brighton , BN2 5, United Kingdom
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London , E1 2A, United Kingdom
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London , SE5 9, United Kingdom
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London , W6 8R, United Kingdom
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London , WC1N , United Kingdom
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Nottingham , NG7 2, United Kingdom
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Sheffield , S10 2, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1501

Study ID:

NCT01797965

Recruitment Status:

Terminated

Sponsor:


Biogen

How clear is this clinincal trial information?

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