Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Participants With Relapsing Forms of Multiple Sclerosis When Used Concurrently With Avonex
NCT ID: NCT01864148
Last Updated: 2017-05-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
419 participants
INTERVENTIONAL
2013-08-31
2016-03-31
Brief Summary
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Secondary objectives of this study in this study population are to assess the safety, tolerability, and population pharmacokinetics of BIIB033 when used concurrently with Avonex.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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BIIB033, 3 mg/kg
BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72.
Avonex once-weekly intramuscular (IM) injection up to Week 84.
BIIB033
Avonex
BIIB033, 10 mg/kg
BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
BIIB033
Avonex
BIIB033, 30 mg/kg
BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
BIIB033
Avonex
BIIB033, 100 mg/kg
BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
BIIB033
Avonex
Placebo
Placebo once every 4 weeks IV infusion up to Week 72.
Avonex once-weekly IM injection up to Week 84.
Placebo
Avonex
Interventions
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BIIB033
Placebo
Avonex
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* RRMS and SPMS subjects must have evidence of ongoing disease activity within 12 months of enrollment.
* All male and female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment
Exclusion Criteria
* Previous history of clinically significant disease.
* Plans to undergo elective major procedures/surgeries at any time during the study.
* Treatment with any investigational MS drugs within 3 weeks or 5 times the half life (whichever is longer) prior to Day 1/Baseline
* RRMS subjects with any history of inadequate response to any approved interferon β preparation
* History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus
* History or evidence of drug or alcohol abuse within 2 years prior to randomization
18 Years
58 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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North Central Neurology Assoc PC
Cullman, Alabama, United States
Phoenix Neurological Associates
Phoenix, Arizona, United States
Raleigh Neurology Associates PA
Raleigh, California, United States
Stanford University Medical Center
Stanford, California, United States
Immunoe International Research Center
Centennial, Colorado, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Michigan Institute For Neurological Disorders
Farmington Hills, Michigan, United States
Washington University
St Louis, Missouri, United States
Multiple Sclerosis Center of North Eastern New York
Latham, New York, United States
OMRF Multiple Sclerosis Center of Excellence
Oklahoma City, Oklahoma, United States
Swedish Medical Center
Seattle, Washington, United States
Research Site
Ottowa, Ontario, Canada
Research Site
Gatinueau, Quebec, Canada
Research Site
Greenfield Park, Quebec, Canada
Research Site
Lévis, Quebec, Canada
Research Site
Montreal, Quebec, Canada
London Health Sciences Centre
London, , Canada
Vseobecna Fakultni Nemocnice V Praze
Prague, Hlavní Mesto, Czechia
Nemocnice Jihlava Prispevkova Organizace
Jihlava, Kraj Vysočina, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Královéhradecký kraj, Czechia
NEUROSPOL Sro
Havířov, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Krajska Zdravotni a.s. Nemocnice Teplice Oz
Teplice, Ústecký kraj, Czechia
Hôpital Guillaume Et René Laënnec
Nantes, Loire-Atlantique, France
Hôpital Maison Blanche
Reims, Marne, France
Hôpital Roger Salengro
Lille, Nord, France
Hôpital Sud
Amiens, Somme, France
Hopital Gabriel Montpied
Clermont-Ferrand, , France
CHRU Nancy
Nancy, , France
Fondation Rothschild
Paris, , France
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
Szeged, Csongrád megye, Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Jahn Ferenc Dél-Pesti Kórház és Rendelöintézet
Budapest, , Hungary
Pécsi Tudományegyetem
Pécs, , Hungary
Azienda Ospedaliera Universitaria San Martino
Genoa, Liguria, Italy
Ospedale San Raffaele S.r.l.
Milan, Lombardy, Italy
Azienda Ospedaliera Spedali Civili di Brescia - Presidio Ospedaliero di Montichiari
Montichiari, Lombardy, Italy
Fondazione Istituto San Raffaele G. Giglio di Cefalù
Cefalù, Palermo, Italy
Azienda Ospedaliero Universitaria Policlinico-Vittorio Emanuele
Catania, Sicily, Italy
Azienda Ospedaliera S. Antonio Abate di Gallarate
Gallarate, Varese, Italy
Erasmus MC
Rotterdam, South Holland, Netherlands
Zuyderland Medisch Centrum
Sittard-Geleen, , Netherlands
Centrum Neurologii K. Selmaj
Lódz, Lódzkie, Poland
Wojskowy Instytut Medyczny
Warsaw, Masovian Voivodeship, Poland
Novo-Med Zielinski i wsp. Sp.J.
Katowice, Silesian Voivodeship, Poland
Pomorskie Centrum Traumatologii im. M. Kopernika w Gdansku
Gdansk, , Poland
Regionalny Szpital Specjalistyczny im. dr Wladyslawa Bieganskiego
Grudziądz, , Poland
M.A.- Lek A.M.Maciejowscy Spolka Cywilna
Katowice, , Poland
Gabriela Klodowska-Duda Neuro-Care NZOZ Site Management Organization
Katowice, , Poland
Neurologiczny NZOZ Centrum Leczenia SM Osrodek Badan Klinicznych Dr n. med. Hanka Hertmanowska
Plewiska, , Poland
Niepubliczny Zaklad Opieki Zdrowotnej NEURO-KARD Ilkowski i Partnerzy Spolka Partnerska Lekarzy
Poznan, , Poland
SPZOZ Wojewodzki Szpital Specjalistyczny w Rybniku
Rybnik, , Poland
EUROMEDIS Sp. z o.o.
Szczecin, , Poland
Kaluga Regional Hospital
Kaluga, , Russia
Republican Clinical Hospital For Rehabilitation Treatment
Kazan', , Russia
Krasnoyarsk State Medical Academy
Krasnoyarsk, , Russia
Perm State Medical Academy
Perm, , Russia
City Center of MS Treatment based on Saint-Petersburg City Clinical Hospital #31
Saint Petersburg, , Russia
Regional Clinical Hospital #3
Volgograd, , Russia
Clinical Center of Serbia
Belgrade, Belgrade, Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
General Hospital Uzice
Užice, , Serbia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Catalonia, Spain
Hospital Universitario Reina Sofia
Córdoba, Córdoba, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Clinico San Carlos
Madrid, Madrid, Communidad Delaware, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
Hospital de Basurto Osakidetza
Bilbao, Vizcaya, Spain
Hospital General Carlos Haya
Málaga, , Spain
Queen's Medical Centre
Nottingham, Nottinghamshire, United Kingdom
Countries
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References
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Cadavid D, Mellion M, Hupperts R, Edwards KR, Calabresi PA, Drulovic J, Giovannoni G, Hartung HP, Arnold DL, Fisher E, Rudick R, Mi S, Chai Y, Li J, Zhang Y, Cheng W, Xu L, Zhu B, Green SM, Chang I, Deykin A, Sheikh SI; SYNERGY study investigators. Safety and efficacy of opicinumab in patients with relapsing multiple sclerosis (SYNERGY): a randomised, placebo-controlled, phase 2 trial. Lancet Neurol. 2019 Sep;18(9):845-856. doi: 10.1016/S1474-4422(19)30137-1. Epub 2019 Jul 5.
Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.
Other Identifiers
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2011-006262-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
215MS201
Identifier Type: -
Identifier Source: org_study_id
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