85
Participants
Start Date
February 20, 2014
Primary Completion Date
June 6, 2018
Study Completion Date
December 23, 2021
Satralizumab
Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Placebo
Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
Baseline Treatment
As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS is also permitted. Change or termination of baseline treatment is only permitted during the open-label extension period.
National Taiwan University Hospital; Neurology, Taipei
Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien, Rome
National Cheng Kung University Hospital; Neurology, Tainan City
Jahn Ferenc Dél-Pesti Kórház, Budapest
NeuroCure Clinical Research Center (NCRC), Berlin
Taipei Veterans General Hospital-Neurology, Taipei
Ospedale San Raffaele, Milan
Hospital Clinico San Carlos; Servicio de Nefrologia, Madrid
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Neurology, Kwei Shen
Children's Hospital of Alabama, Birmingham
Heinrich-Heine Universitätsklinik Düsseldorf, Düsseldorf
China Medical University Hospital; Neurology - Taichung, Taichung
St. Josef-Hospital, Klinik für Neurologie, Bochum
"KZ Dnipropetrovska oblasna dytiacha klinichna likarnia DOR", Dnipropetrovsk
Kharkivska miska dytiacha likarnia # 5, Kharkiv
Hopital de Hautepierre CHRU de Strasbourg, Strasbourg
Fond. Ist. S. Raffaele - giglio, Cefalù
PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania, Catania
Juntendo University Hospital; Neurology, Bunkyō City
Kyushu University Hospital; Neurology, Fukuoka
Fukushima Medical University Hospital; Neurology, Fukushima
Kagoshima University Medical And Dental Hospital; Neurology and Geriatorics, Kagoshima
Niigata University Medical and Dental Hospital; Neurology, Niigata
Kindai University Hospital; Neurology, Osaka
Tohoku University Hospital; Neurology, Sendai
Tokyo Women's Medical University Hospital; Neurology, Shinjuku-ku
Osaka University Hospital; Neurology, Suita
National Center of Neurology and Psychiatry, Tokyo
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Katowice
M.A. - LEK A. M. Maciejowscy SC. Centrum Terapii SM, Katowice
Centrum Medyczne Dendryt, Katowice
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin
Szpital Kliniczny im. H.Swiecickiego UM w Poznaniu, Późna
Samodzielny Publiczny Centralny Szpital Klinicznyi, Warsaw
Instytut Psychiatrii i Neurologii, Warsaw
Hospital Clinic de Barcelona, Barcelona
University Hospital of Wales; Dept of Neurology, Cardiff
John Radcliffe Hospital; Neurosciences, Chinnor
The National Hospital for Neurology & Neurosurgery, London
Great Ormond Street Hospital For Children; Neurology, London
Collaborators (1)
Chugai Pharmaceutical
INDUSTRY
Hoffmann-La Roche
INDUSTRY