Multiple Sclerosis Clinical Trial
Efficacy and Safety Study of Peginterferon Beta-1a in Participants With Relapsing Multiple Sclerosis
Summary
The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.
Full Description
This is a global multicenter, randomized, double-blind, parallel-group, placebo-controlled study. The treatment period is 96 weeks (2 years) in duration. Treatment Year 1 (Week 0 to Week 48) is referred to as the placebo-controlled treatment period of the study. At the beginning of Treatment Year 1, participants were randomized to receive placebo, peginterferon beta-1a 125 μg every 2 weeks, or peginterferon beta-1a 125 μg every 4 weeks. At the end of Treatment Year 1, participants in the placebo group were re-randomized to receive peginterferon beta-1a treatment so that during treatment Year 2 (Weeks 48 to Week 96) all participants received peginterferon beta-1a 125 μg every 2 or every 4 weeks. Per protocol, all primary and secondary endpoints pertain to Year 1 data.
Eligibility Criteria
Key Inclusion Criteria:
Must have a confirmed diagnosis of relapsing multiple sclerosis (RMS), as defined by McDonald criteria 1 through 4 (Polman, 2005)
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
Key Exclusion Criteria:
Other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease
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
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 169 Locations for this study
Phoenix Arizona, 85013, United States
Ponte Vedra Beach Florida, 32082, United States
Atlanta Georgia, 30327, United States
Des Moines Iowa, 50314, United States
Lexington Kentucky, 40513, United States
Baltimore Maryland, 21287, United States
Teaneck New Jersey, 07666, United States
Raleigh North Carolina, 27607, United States
Akron Ohio, 44320, United States
Cleveland Ohio, 44195, United States
Franklin Tennessee, 37064, United States
Round Rock Texas, 78681, United States
'Sint-Truiden , 3800, Belgium
Bruxelles , 1200, Belgium
Plovdiv , 4002, Bulgaria
Sofia , 1113, Bulgaria
Sofia , 1309, Bulgaria
Sofia , 1407, Bulgaria
Sofia , 1431, Bulgaria
Sofia , 1527, Bulgaria
Sofia , 1606, Bulgaria
London Ontario, N6A 5, Canada
Montreal Quebec, H2L4M, Canada
Santiago , 82072, Chile
Barranquilla Atlantico, , Colombia
Bogota Cundinamarca, , Colombia
Bogota , , Colombia
Osijek , 31000, Croatia
Zagreb , 10000, Croatia
Brno , 62500, Czech Republic
Olomouc , 77520, Czech Republic
Ostrava - Vitkovice , 70200, Czech Republic
Ostrava-Poruba , 70300, Czech Republic
Ostrava , 70852, Czech Republic
Praha 2 , 12808, Czech Republic
Praha 5 , 15006, Czech Republic
Teplice , 41529, Czech Republic
Parnu , EE 80, Estonia
Tallinn , EE 10, Estonia
Tartu , EE 51, Estonia
Amiens , 80054, France
Clermont-Ferrand , 63003, France
Lyon , 69394, France
Marseille , 13385, France
Nice , 6002, France
Tbilisi , 112, Georgia
Tbilisi , 141, Georgia
Tbilisi , 179, Georgia
Tbilisi , 186, Georgia
Bayreuth , 95445, Germany
Berlin , 10713, Germany
Berlin , 14163, Germany
Bochum , 44791, Germany
Erbach , 64711, Germany
Erlangen , 91054, Germany
Hamburg , 20099, Germany
Hannover , 30559, Germany
Koln , 50935, Germany
Leipzig , 04103, Germany
Marburg , 35043, Germany
Munchen , 80331, Germany
Munster , 48149, Germany
Prien , 83209, Germany
Ulm , 89079, Germany
Westerstede , 26655, Germany
Athens , 11521, Greece
Athens , 11525, Greece
Thessaloniki , 57010, Greece
New Delhi Delhi, 11002, India
New Delhi Delhi, 11006, India
Saket Delhi, 11001, India
Ahmedabad Gujarat, 38000, India
Rajkot Gujarat, 36000, India
Bangalore Karnataka, 56004, India
Indore Madhyr Pradesh, 45201, India
Mumbai Maharashtra, 40002, India
Nagpur Maharashtra, 44001, India
Nasik Maharashtra, 42200, India
Pune Maharashtra, 41100, India
Pune Maharashtra, 41103, India
Amritsar Punjab, 14300, India
Jaipur Rajasthan, 30200, India
Chennai Tamil Nadu, 60001, India
Coimbatore Tamil Nadu, 64101, India
Kolkata West Bengal, 70006, India
Bangalore , 56001, India
Mangalore , 57501, India
Navi Mumbai , 40070, India
Nehru Nagar , 11006, India
Riga , LV 10, Latvia
Aquas Calientes , 20127, Mexico
Chihuahua , 31203, Mexico
Mexico City , 10700, Mexico
Mexico DF , 03310, Mexico
Monterrey, Nuevo Leon , 64710, Mexico
Tijuana, Baja California , 22320, Mexico
Breda , 4818C, Netherlands
Nieuwegein , 3435C, Netherlands
Auckland , 1023, New Zealand
Christchurch , , New Zealand
Dunedin , , New Zealand
Lima , Lima , Peru
Lima , Lima , Peru
Lima , Lima , Peru
San Isidro , Lima , Peru
Bialystok , 15276, Poland
Bialystok , 15402, Poland
Bydgoszcz , 85681, Poland
Gdansk , 80299, Poland
Gdansk , 80803, Poland
Gdansk , 80952, Poland
Katowice , 40650, Poland
Katowice , 40662, Poland
Katowice , 40684, Poland
Konskie , 26200, Poland
Krakow , 31505, Poland
Krakow , 31637, Poland
Krakow , 31826, Poland
Lodz , 90153, Poland
Lublin , 20718, Poland
Lublin , 20954, Poland
Olsztyn , 10082, Poland
Plewiska , 62064, Poland
Poznan , 60355, Poland
Poznan , 61853, Poland
Szczecin , 70215, Poland
Szczecin , 71252, Poland
Warsawa , 00851, Poland
Warsawa , 02957, Poland
Warsawa , 04141, Poland
Warsawa , 04749, Poland
Wroclaw , 50556, Poland
Zabrze , 41800, Poland
Brasov , 50012, Romania
Bucharest , 50098, Romania
Campulung , 11510, Romania
Iasi , 70065, Romania
Sibiu , 55016, Romania
Targu Mures , 54013, Romania
Chelyabinsk , 45413, Russian Federation
Kaluga , 24800, Russian Federation
Kazan , 42002, Russian Federation
Krasnodar , 35001, Russian Federation
Kursk , 30500, Russian Federation
Moscow , 10715, Russian Federation
Moscow , 11902, Russian Federation
Moscow , 12536, Russian Federation
Moscow , 12701, Russian Federation
Novosibirsk , 63000, Russian Federation
Perm , 61499, Russian Federation
Rostov-on-Don , 34401, Russian Federation
Smolensk , 21401, Russian Federation
Tomsk , 63405, Russian Federation
Ufa , 45000, Russian Federation
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Nis , 18000, Serbia
Cordoba , 14008, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Malaga , 29010, Spain
Sevilla , 41071, Spain
Chernivtsi , 58018, Ukraine
Dnipropetrovsk , 49027, Ukraine
Donetsk , 83099, Ukraine
Kharkiv , 61068, Ukraine
Kharkiv , 61103, Ukraine
Kyiv , 3110, Ukraine
Kyiv , 4107, Ukraine
Odesa , 65025, Ukraine
Poltava , 26011, Ukraine
Simferopol , 95017, Ukraine
Ternopil , 46027, Ukraine
Vinnytsya , 21005, Ukraine
London , E1 1B, United Kingdom
Nottingham , NG7 2, United Kingdom
Salford , M6 8H, United Kingdom
Sheffield , S10 2, United Kingdom
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