Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
NCT ID: NCT00906399
Last Updated: 2014-09-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1516 participants
INTERVENTIONAL
2009-06-30
2013-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Placebo
Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 or 4 weeks for 48 weeks.
BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Placebo
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Peginterferon Beta-1a Q2W
125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 96 weeks.
BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Peginterferon Beta-1a Q4W
125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 96 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Placebo
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Interventions
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BIIB017 (peginterferon beta-1a)
Supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 µg dose), self-administered by subcutaneous injection.
Placebo
Matched placebo provided in pre-filled syringes, to deliver 0.5 mL self-administered by subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have an EDSS score between 0.0 and 5.0.
* Must have experienced at least 2 relapses that have been medically documented within the last 3 years with at least one occurring in the last 12 months
Exclusion Criteria
* Pregnant or nursing women
* Prior treatment with interferon could not exceed 4 weeks and subjects must have discontinued interferon treatment 6 months prior to Baseline
18 Years
65 Years
ALL
No
Sponsors
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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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Ponte Vedra Beach, Florida, United States
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Atlanta, Georgia, United States
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Des Moines, Iowa, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, United States
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Teaneck, New Jersey, United States
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Raleigh, North Carolina, United States
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Akron, Ohio, United States
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Cleveland, Ohio, United States
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Franklin, Tennessee, United States
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Round Rock, Texas, United States
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Brussels, , Belgium
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Sint-Truiden, , Belgium
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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London, Ontario, Canada
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Montreal, Quebec, Canada
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Santiago, , Chile
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Barranquilla, Atlántico, Colombia
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Bogota, Cundinamarca, Colombia
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Bogotá, , Colombia
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Osijek, , Croatia
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Zagreb, , Croatia
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Brno, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Ostrava - Vitkovice, , Czechia
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Ostrava-Poruba, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Teplice, , Czechia
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Pärnu, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Amiens, , France
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Clermont-Ferrand, , France
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Lyon, , France
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Marseille, , France
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Nice, , France
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Tbilisi, , Georgia
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Bayreuth, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bochum, , Germany
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Cologne, , Germany
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Erbach im Odenwald, , Germany
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Erlangen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Marburg, , Germany
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München, , Germany
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Münster, , Germany
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Prien am Chiemsee, , Germany
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Ulm, , Germany
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Westerstede, , Germany
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Athens, , Greece
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Athens, , Greece
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Thessaloniki, , Greece
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Ahmedabad, Gujarat, India
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Rajkot, Gujarat, India
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Bangalore, Karnataka, India
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Indore, Madhyr Pradesh, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Nashik, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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New Delhi, National Capital Territory of Delhi, India
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Saket, National Capital Territory of Delhi, India
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Amritsar, Punjab, India
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Jaipur, Rajasthan, India
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Chennai, Tamil Nadu, India
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Coimbatore, Tamil Nadu, India
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Kolkata, West Bengal, India
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Bangalore, , India
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Mangalore, , India
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Navi Mumbai, , India
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Nehru Nagar, , India
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Riga, , Latvia
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Aquas Calientes, , Mexico
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Chihuahua City, , Mexico
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Mexico City, , Mexico
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Mexico City, , Mexico
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Monterrey, Nuevo Leon, , Mexico
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Tijuana, Baja California, , Mexico
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Breda, , Netherlands
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Nieuwegein, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Dunedin, , New Zealand
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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San Isidro, , Peru
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Bialystok, , Poland
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdansk, , Poland
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Gdansk, , Poland
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Gdansk, , Poland
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Gmina Końskie, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Lublin, , Poland
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Olsztyn, , Poland
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Plewiska, , Poland
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Poznan, , Poland
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Poznan, , Poland
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Szczecin, , Poland
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Szczecin, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Campulung Muscel, , Romania
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Iași, , Romania
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Sibiu, , Romania
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Târgu Mureş, , Romania
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Chelyabinsk, , Russia
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Kaluga, , Russia
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Kazan', , Russia
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Krasnodar, , Russia
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Kursk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Perm, , Russia
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Rostov-on-Don, , Russia
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Smolensk, , Russia
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Tomsk, , 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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Córdoba, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Chernivtsi, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kharkiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Simferopol, , Ukraine
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Ternopil, , Ukraine
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Vinnytsia, , Ukraine
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London, , United Kingdom
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Nottingham, , 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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Calabresi PA, Kieseier BC, Arnold DL, Balcer LJ, Boyko A, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A; ADVANCE Study Investigators. Pegylated interferon beta-1a for relapsing-remitting multiple sclerosis (ADVANCE): a randomised, phase 3, double-blind study. Lancet Neurol. 2014 Jul;13(7):657-65. doi: 10.1016/S1474-4422(14)70068-7. Epub 2014 Apr 30.
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.
Calabresi PA, Arnold DL, Sangurdekar D, Singh CM, Altincatal A, de Moor C, Engle B, Goyal J, Deykin A, Szak S, Kieseier BC, Rudick RA, Plavina T. Temporal profile of serum neurofilament light in multiple sclerosis: Implications for patient monitoring. Mult Scler. 2021 Sep;27(10):1497-1505. doi: 10.1177/1352458520972573. Epub 2020 Dec 14.
Cleanthous S, Cano S, Kinter E, Marquis P, Petrillo J, You X, Wakeford C, Sabatella G. Measuring the impact of multiple sclerosis: Enhancing the measurement performance of the Multiple Sclerosis Impact Scale (MSIS-29) using Rasch Measurement Theory (RMT). Mult Scler J Exp Transl Clin. 2017 Aug 15;3(3):2055217317725917. doi: 10.1177/2055217317725917. eCollection 2017 Jul-Sep.
Scott TF, Kieseier BC, Newsome SD, Arnold DL, You X, Hung S, Sperling B. Improvement in relapse recovery with peginterferon beta-1a in patients with multiple sclerosis. Mult Scler J Exp Transl Clin. 2016 Nov 15;2:2055217316676644. doi: 10.1177/2055217316676644. eCollection 2016 Jan-Dec.
Newsome SD, Kieseier BC, Liu S, You X, Kinter E, Hung S, Sperling B. Peginterferon beta-1a reduces disability worsening in relapsing-remitting multiple sclerosis: 2-year results from ADVANCE. Ther Adv Neurol Disord. 2017 Jan;10(1):41-50. doi: 10.1177/1756285616676065. Epub 2016 Nov 16.
Arnold DL, Calabresi PA, Kieseier BC, Liu S, You X, Fiore D, Hung S. Peginterferon beta-1a improves MRI measures and increases the proportion of patients with no evidence of disease activity in relapsing-remitting multiple sclerosis: 2-year results from the ADVANCE randomized controlled trial. BMC Neurol. 2017 Feb 10;17(1):29. doi: 10.1186/s12883-017-0799-0.
Newsome SD, Guo S, Altincatal A, Proskorovsky I, Kinter E, Phillips G, You X, Sabatella G. Impact of peginterferon beta-1a and disease factors on quality of life in multiple sclerosis. Mult Scler Relat Disord. 2015 Jul;4(4):350-7. doi: 10.1016/j.msard.2015.06.004. Epub 2015 Jun 14.
Arnold DL, Calabresi PA, Kieseier BC, Sheikh SI, Deykin A, Zhu Y, Liu S, You X, Sperling B, Hung S. Effect of peginterferon beta-1a on MRI measures and achieving no evidence of disease activity: results from a randomized controlled trial in relapsing-remitting multiple sclerosis. BMC Neurol. 2014 Dec 31;14:240. doi: 10.1186/s12883-014-0240-x.
Kieseier BC, Arnold DL, Balcer LJ, Boyko AA, Pelletier J, Liu S, Zhu Y, Seddighzadeh A, Hung S, Deykin A, Sheikh SI, Calabresi PA. Peginterferon beta-1a in multiple sclerosis: 2-year results from ADVANCE. Mult Scler. 2015 Jul;21(8):1025-35. doi: 10.1177/1352458514557986. Epub 2014 Nov 28.
Hu X, Cui Y, White J, Zhu Y, Deykin A, Nestorov I, Hung S. Pharmacokinetics and pharmacodynamics of peginterferon beta-1a in patients with relapsing-remitting multiple sclerosis in the randomized ADVANCE study. Br J Clin Pharmacol. 2015 Mar;79(3):514-22. doi: 10.1111/bcp.12521.
Other Identifiers
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2008-006333-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
105MS301
Identifier Type: -
Identifier Source: org_study_id
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