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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1516

Study ID:

NCT00906399

Recruitment Status:

Completed

Sponsor:

Biogen

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There are 169 Locations for this study

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Phoenix Arizona, 85013, United States
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Ponte Vedra Beach Florida, 32082, United States
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Atlanta Georgia, 30327, United States
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Des Moines Iowa, 50314, United States
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Lexington Kentucky, 40513, United States
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Baltimore Maryland, 21287, United States
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Teaneck New Jersey, 07666, United States
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Raleigh North Carolina, 27607, United States
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Akron Ohio, 44320, United States
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Cleveland Ohio, 44195, United States
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Franklin Tennessee, 37064, United States
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Round Rock Texas, 78681, United States
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'Sint-Truiden , 3800, Belgium
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Bruxelles , 1200, Belgium
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Plovdiv , 4002, Bulgaria
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Sofia , 1113, Bulgaria
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Sofia , 1309, Bulgaria
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Sofia , 1407, Bulgaria
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Sofia , 1431, Bulgaria
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Sofia , 1527, Bulgaria
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Sofia , 1606, Bulgaria
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London Ontario, N6A 5, Canada
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Montreal Quebec, H2L4M, Canada
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Santiago , 82072, Chile
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Barranquilla Atlantico, , Colombia
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Bogota Cundinamarca, , Colombia
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Bogota , , Colombia
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Osijek , 31000, Croatia
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Zagreb , 10000, Croatia
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Brno , 62500, Czech Republic
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Olomouc , 77520, Czech Republic
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Ostrava - Vitkovice , 70200, Czech Republic
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Ostrava-Poruba , 70300, Czech Republic
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Ostrava , 70852, Czech Republic
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Praha 2 , 12808, Czech Republic
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Praha 5 , 15006, Czech Republic
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Teplice , 41529, Czech Republic
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Parnu , EE 80, Estonia
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Tallinn , EE 10, Estonia
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Tartu , EE 51, Estonia
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Amiens , 80054, France
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Clermont-Ferrand , 63003, France
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Lyon , 69394, France
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Marseille , 13385, France
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Nice , 6002, France
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Tbilisi , 112, Georgia
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Tbilisi , 141, Georgia
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Tbilisi , 179, Georgia
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Tbilisi , 186, Georgia
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Bayreuth , 95445, Germany
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Berlin , 10713, Germany
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Berlin , 14163, Germany
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Bochum , 44791, Germany
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Erbach , 64711, Germany
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Erlangen , 91054, Germany
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Hamburg , 20099, Germany
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Hannover , 30559, Germany
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Koln , 50935, Germany
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Leipzig , 04103, Germany
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Marburg , 35043, Germany
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Munchen , 80331, Germany
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Munster , 48149, Germany
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Prien , 83209, Germany
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Ulm , 89079, Germany
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Westerstede , 26655, Germany
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Athens , 11521, Greece
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Athens , 11525, Greece
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Thessaloniki , 57010, Greece
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New Delhi Delhi, 11002, India
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New Delhi Delhi, 11006, India
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Saket Delhi, 11001, India
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Ahmedabad Gujarat, 38000, India
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Rajkot Gujarat, 36000, India
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Bangalore Karnataka, 56004, India
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Indore Madhyr Pradesh, 45201, India
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Mumbai Maharashtra, 40002, India
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Nagpur Maharashtra, 44001, India
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Nasik Maharashtra, 42200, India
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Pune Maharashtra, 41100, India
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Pune Maharashtra, 41103, India
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Amritsar Punjab, 14300, India
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Jaipur Rajasthan, 30200, India
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Chennai Tamil Nadu, 60001, India
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Coimbatore Tamil Nadu, 64101, India
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Kolkata West Bengal, 70006, India
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Bangalore , 56001, India
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Mangalore , 57501, India
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Navi Mumbai , 40070, India
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Nehru Nagar , 11006, India
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Riga , LV 10, Latvia
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Aquas Calientes , 20127, Mexico
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Chihuahua , 31203, Mexico
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Mexico City , 10700, Mexico
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Mexico DF , 03310, Mexico
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Monterrey, Nuevo Leon , 64710, Mexico
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Tijuana, Baja California , 22320, Mexico
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Breda , 4818C, Netherlands
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Nieuwegein , 3435C, Netherlands
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Auckland , 1023, New Zealand
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Christchurch , , New Zealand
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Dunedin , , New Zealand
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Lima , Lima , Peru
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Lima , Lima , Peru
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Lima , Lima , Peru
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San Isidro , Lima , Peru
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Bialystok , 15276, Poland
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Bialystok , 15402, Poland
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Bydgoszcz , 85681, Poland
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Gdansk , 80299, Poland
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Gdansk , 80803, Poland
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Gdansk , 80952, Poland
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Katowice , 40650, Poland
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Katowice , 40662, Poland
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Katowice , 40684, Poland
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Konskie , 26200, Poland
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Krakow , 31505, Poland
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Krakow , 31637, Poland
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Krakow , 31826, Poland
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Lodz , 90153, Poland
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Lublin , 20718, Poland
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Lublin , 20954, Poland
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Olsztyn , 10082, Poland
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Plewiska , 62064, Poland
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Poznan , 60355, Poland
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Poznan , 61853, Poland
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Szczecin , 70215, Poland
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Szczecin , 71252, Poland
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Warsawa , 00851, Poland
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Warsawa , 02957, Poland
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Warsawa , 04141, Poland
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Warsawa , 04749, Poland
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Wroclaw , 50556, Poland
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Zabrze , 41800, Poland
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Brasov , 50012, Romania
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Bucharest , 50098, Romania
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Campulung , 11510, Romania
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Iasi , 70065, Romania
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Sibiu , 55016, Romania
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Targu Mures , 54013, Romania
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Chelyabinsk , 45413, Russian Federation
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Kaluga , 24800, Russian Federation
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Kazan , 42002, Russian Federation
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Krasnodar , 35001, Russian Federation
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Kursk , 30500, Russian Federation
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Moscow , 10715, Russian Federation
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Moscow , 11902, Russian Federation
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Moscow , 12536, Russian Federation
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Moscow , 12701, Russian Federation
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Novosibirsk , 63000, Russian Federation
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Perm , 61499, Russian Federation
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Rostov-on-Don , 34401, Russian Federation
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Smolensk , 21401, Russian Federation
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Tomsk , 63405, 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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Cordoba , 14008, Spain
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Madrid , 28041, Spain
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Madrid , 28046, Spain
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Malaga , 29010, Spain
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Sevilla , 41071, Spain
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Chernivtsi , 58018, Ukraine
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Dnipropetrovsk , 49027, Ukraine
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Donetsk , 83099, Ukraine
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Kharkiv , 61068, Ukraine
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Kharkiv , 61103, Ukraine
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Kyiv , 3110, Ukraine
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Kyiv , 4107, Ukraine
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Odesa , 65025, Ukraine
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Poltava , 26011, Ukraine
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Simferopol , 95017, Ukraine
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Ternopil , 46027, Ukraine
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Vinnytsya , 21005, Ukraine
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London , E1 1B, United Kingdom
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Nottingham , NG7 2, United Kingdom
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Salford , M6 8H, 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:

1516

Study ID:

NCT00906399

Recruitment Status:

Completed

Sponsor:


Biogen

How clear is this clinincal trial information?

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