Long-Term Extension Study in Participants With Multiple Sclerosis Who Have Completed Study 205MS301 (NCT01064401) to Evaluate the Safety and Efficacy of BIIB019
NCT ID: NCT01797965
Last Updated: 2019-12-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
1501 participants
INTERVENTIONAL
2013-02-15
2018-09-24
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BIIB019
BIIB019 150 mg subcutaneous (SC) every 4 weeks
BIIB019 (Daclizumab)
Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
Interventions
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BIIB019 (Daclizumab)
Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 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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Phoenix, 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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Centennial, Colorado, United States
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Naples, Florida, United States
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Pompano Beach, Florida, United States
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Atlanta, Georgia, United States
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Fort Wayne, Indiana, United States
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Indianapolis, Indiana, United States
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Kansas City, Kansas, United States
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Lexington, Kentucky, United States
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Wellesley, Massachusetts, United States
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Worcester, Massachusetts, United States
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Farmington Hills, Michigan, United States
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Lebanon, New Hampshire, 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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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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Dayton, Ohio, 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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Pittsburgh, Pennsylvania, United States
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Cordova, Tennessee, United States
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Franklin, Tennessee, United States
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Knoxville, Tennessee, United States
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Round Rock, Texas, United States
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Henrico, Virginia, 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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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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Auchenflower, Queensland, Australia
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Heidelberg, Victoria, Australia
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Belo Horizonte, Minas Gerais, Brazil
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Recife, Pernambuco, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Campinas, São Paulo, Brazil
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Ribeirão Preto, São Paulo, Brazil
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Rio de Janeiro, , Brazil
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Rio de Janeiro, , Brazil
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Vancouver, British Columbia, Canada
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Saint Johns, 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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Jihlava, Kray Vysocina, Czechia
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Ostrava, Moravskoslezský kraj, Czechia
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Pardubice, Pardubický kraj, Czechia
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Prague, Prague, Czechia
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Prague, Prague, Czechia
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Olomouc, Severomoravsky Kraj, Czechia
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Brno, South Moravian, Czechia
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Brno, South Moravian, Czechia
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Hradec Králové, , Czechia
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Prague, , Czechia
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Teplice, Ústecký kraj, Czechia
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Copenhagen, , Denmark
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Glostrup Municipality, , Denmark
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Odense C, , Denmark
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Strasbourg, Bas-Rhin, France
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Marseille, Bouches-du-Rhône, France
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Caen, Calvados, France
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Bordeaux, Gironde, France
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Toulouse, Haute-Garonne, France
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Nancy, Meurthe-et-Moselle, France
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Lille, Nord, France
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Amiens, , France
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Paris, , France
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Bobigny, 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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Bayreuth, Bavaria, Germany
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Erlangen, Bavaria, Germany
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München, Bavaria, Germany
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Marburg, Hesse, Germany
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Rostock, Mecklenburg-Vorpommern, Germany
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Dresden, Saxony, Germany
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Bamberg, , Germany
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Athens, Attica, Greece
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Thessaloniki, Macedonia, Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Miskolc, Borsod-Abauj Zemplen county, Hungary
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Kecskemét, Bács-Kiskun county, Hungary
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Székesfehérvár, Fejér, Hungary
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Balatonfüred, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Esztergom, , Hungary
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Győr, , Hungary
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Miskolc, , Hungary
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Nyíregyháza, , Hungary
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Hyderabad, Andhra Pradesh, 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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Gurgaon, , India
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Dublin, , Ireland
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Dublin, , Ireland
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Ashkelon, , Israel
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Haifa, , Israel
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Petah Tikva, , Israel
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Safed, , Israel
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Genoa, Liguria, Italy
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Milan, Lombardy, Italy
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Padua, Veneto, Italy
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Catania, , Italy
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Cefalù, , Italy
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Roma, , Italy
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Roma, , Italy
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Distrito Federal, , Mexico
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Distrito Federal, , Mexico
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Chisinau, , Moldova
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Chisinau, , Moldova
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Plewiska, Greater Poland Voivodeship, Poland
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Poznan, Greater Poland Voivodeship, Poland
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Poznan, Greater Poland Voivodeship, Poland
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Poznan, Greater Poland Voivodeship, Poland
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Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Krakow, Lesser Poland Voivodeship, Poland
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Lublin, Lublin Voivodeship, Poland
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Lodz, Lódzkie, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Warsaw, Masovian Voivodeship, Poland
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Bialystok, Podlaskie Voivodeship, Poland
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Bialystok, Podlaskie Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Gdansk, Pomeranian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Katowice, Silesian Voivodeship, Poland
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Olsztyn, Warmian-Masurian Voivodeship, Poland
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Szczecin, West Pomeranian Voivodeship, Poland
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Szczecin, West Pomeranian Voivodeship, Poland
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Gdansk, , Poland
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Grudziądz, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Olsztyn, , Poland
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Kielce, Świętokrzyskie Voivodeship, Poland
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Cluj-Napoca, Cluj, Romania
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Târgu Mures, Mureș County, Romania
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Timișoara, Timiș County, Romania
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Bucharest, , Romania
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Iași, , Romania
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Yaroslavl, Yaroslavlr, Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Nizhny Novgorod, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Perm, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Smolensk, , 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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Badalona, Barcelona, Spain
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Córdoba, Córdoba, Spain
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Madrid, Madrid, Communidad Delaware, Spain
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Girona, , Spain
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L'Hospitalet de Llobregat, , Spain
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Seville, , Spain
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Malmo, Skåne County, Sweden
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Stockholm, Södermanland County, Sweden
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Stockholm, Södermanland County, Sweden
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Gothenburg, Västra Götaland County, Sweden
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Stockholm, , Sweden
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Basel, Basel-Stadt (de), Switzerland
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Chernivtsi, Chernivtsi Oblast, Ukraine
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Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
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Donetsk, Donetsk Oblast, Ukraine
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Kharkiv, Kharkivs’ka Oblast’, Ukraine
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Kyiv, Kyïv, Ukraine
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Kyiv, Kyïv, Ukraine
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Kyiv, Kyïv, Ukraine
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Odesa, Odesa Oblast, Ukraine
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Poltava, Poltava Oblast, Ukraine
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Vinnytsia, Vinnytsia Oblast, Ukraine
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Zaporizhzhia, Zaporizhzhia Oblast, Ukraine
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Zaporizhzhia, Zaporizhzhia Oblast, Ukraine
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Kharkiv, , Ukraine
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Plymouth, Devon, United Kingdom
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Edinburgh, Edinburgh, City of, United Kingdom
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Brighton, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Nottingham, , United Kingdom
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Sheffield, , United Kingdom
Countries
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References
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Gold R, Stefoski D, Selmaj K, Havrdova E, Hurst C, Holman J, Tornesi B, Akella S, McCroskery P. Pregnancy Experience: Nonclinical Studies and Pregnancy Outcomes in the Daclizumab Clinical Study Program. Neurol Ther. 2016 Dec;5(2):169-182. doi: 10.1007/s40120-016-0048-2. Epub 2016 Jul 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2012-003176-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
205MS303
Identifier Type: -
Identifier Source: org_study_id
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