Long-Term Safety and Efficacy Study of Peginterferon Beta-1a
NCT ID: NCT01332019
Last Updated: 2017-01-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1077 participants
INTERVENTIONAL
2011-04-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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peginterferon beta-1a Q4W
125 µg peginterferon beta-1a administered by subcutaneous (SC) injection every 4 weeks (Q4W) for at least 2 years and up to 4 years.
peginterferon beta-1a
Administered as specified in the treatment arm
peginterferon beta-1a Q2W
125 μg peginterferon beta-1a administered by SC injection every 2 weeks (Q2W) for at least 2 years and up to 4 years.
peginterferon beta-1a
Administered as specified in the treatment arm
Interventions
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peginterferon beta-1a
Administered as specified in the treatment arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subjects with any clinically significant laboratory abnormalities, malignancies, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease
* Pregnant or nursing women.
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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Research Site
Atlanta, Georgia, United States
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Lexington, Kentucky, United States
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Baltimore, Maryland, 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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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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London, Ontario, Canada
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Montreal, Quebec, Canada
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Santiago, , Chile
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Zagreb, , Croatia
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Brno, , Czechia
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Havffov, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Ostrava-Vitkovice, , 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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Bouches-du-Rhone, , France
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Clermont-Ferrand, , 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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Cologne, , Germany
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Erbach im Odenwald, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Marberg, , 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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Indore, Madhyr Pradesh, India
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Mumbai, Maharashtra, India
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Nagpur, Maharashtra, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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Amritsar, Punjab, 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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Chennai, , India
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Mangalore, , India
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Navi Mumbai, , India
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New Delhi, , India
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New Delhi, , India
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Sāket, , India
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Riga, , Latvia
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Aguascalientes, , Mexico
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Chihuahua City, , Mexico
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Héroes de Padierna, , Mexico
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Mexico City, , Mexico
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Monterrey, , 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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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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Wroclaw, , Poland
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Brasov, , Romania
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Bucharest, , Romania
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Campulung Muscel, , Romania
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Sibiu, , Romania
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Târgu Mureş, , Romania
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Kaluga, , Russia
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Kazan', , Russia
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Kransodar, , Russia
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Kursk, , 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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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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Manchester, , 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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Arnold DL, Shang S, Dong Q, Meergans M, Naylor ML. Peginterferon beta-1a every 2 weeks increased achievement of no evidence of disease activity over 4 years in the ADVANCE and ATTAIN studies in patients with relapsing-remitting multiple sclerosis. Ther Adv Neurol Disord. 2018 Aug 28;11:1756286418795085. doi: 10.1177/1756286418795085. eCollection 2018.
Seddighzadeh A, Hung S, Selmaj K, Cui Y, Liu S, Sperling B, Calabresi PA. Single-use autoinjector for peginterferon-beta1a treatment of relapsing-remitting multiple sclerosis: safety, tolerability and patient evaluation data from the Phase IIIb ATTAIN study. Expert Opin Drug Deliv. 2014 Nov;11(11):1713-20. doi: 10.1517/17425247.2014.944159. Epub 2014 Jul 29.
Other Identifiers
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2010-024477-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
105MS302
Identifier Type: -
Identifier Source: org_study_id
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