Efficacy and Safety Study of Satralizumab (SA237) as Monotherapy to Treat Participants With Neuromyelitis Optica (NMO) and Neuromyelitis Optica Spectrum Disorder (NMOSD)

PHASE3CompletedINTERVENTIONAL
Enrollment

95

Participants

Timeline

Start Date

August 5, 2014

Primary Completion Date

October 12, 2018

Study Completion Date

January 31, 2022

Conditions
Neuromyelitis Optica (NMO)NMO Spectrum Disorder (NMOSD)
Interventions
DRUG

Satralizumab

Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

DRUG

Placebo

Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).

Trial Locations (58)

704

National Cheng Kung University Hospital; Neurology, Tainan City

1000

Philippine General Hospital, Manila

1113

MHATNP Sveti Naum EAD, Sofia

1431

UMHAT Alexandrovska, EAD, Sofia

3110

Kiev National Medical University, Kiev

3722

Severance Hospital - Yonsei University Health System - Neurology, Seoul

4107

"Municipal Foundation of Kyiv Regional Council Kyiv Region", Kyiv

5800

MMA-MHAT Pleven - Clinic for Neurology, Pleven

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

9300

Medical Help Center EOOD, Dobrich

11217

Taipei Veterans General Hospital-Neurology, Taipei

16150

Hospital Universiti Sains Malaysia [Neurology], Kubang Kerian

19107

Thomas Jefferson University, Philadelphia

21005

Vinnytskyi natsionalnyi medychnyi universytet imeni M.I. Pyr, Vinnytsia

27599

University of North Carolina at Chapel Hill, Chapel Hill

28204

The Neurological Institute PA, Charlotte

31000

Klinicki bolnicki centar Osijek, Osijek

31909

Columbus Research and Wellness, Columbus

32962

The MS Center of Vero Beach, Vero Beach

33136

University of Miami UHealth Professional Arts Center, Miami

34333

Bilim University Medical Faculty Florence Nightingale Hospital, Istanbul

40447

China Medical University Healthcare System, Taichung

43214

OhioHealth Research Institute, Columbus

46014

Reginal clinical psyconeurological hospital, Ternopil

48201

Wayne State University - Comp Clinic and MS. Center, Detroit

49100

Miska Klinichna Likarnia №16, Dnipropetrovsk

50586

Hospital Kuala Lumpur, Kuala Lumpur

53215

Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders, Milwaukee

55139

Ondokuz Mayis Univ. Med. Fac., Samsun

60062

Consultants in Neurology Ltd, Northbrook

60637

University of Chicago; Neurology, Chicago

64637

OSF Saint Francis Medical Center, Peoria

65006

"KU Odeskyi oblasnyi medychnyi tsentr psykhichnoho zdorovia", Odesa

66160

University of Kansas Medical Center, Kansas City

66206

MidAmerica Neuroscience Institute, Prairie Village

69068

"Municipal Establishment City Clinical Hospital #2; Neurology", Zaporozhya

75390

University of Texas Southwestern Medical Center, Dallas

76008

Ivano-Frankivska oblasna klinichna likarnia, Ivano-Frankivsk

76018

Ivano-Frankivska miska klinichna likarnia №1, Ivano-Frankivsk

78229

UT Medicine San Antonio, San Antonio

78681

Central Texas Neurology Consultants, Round Rock

80045

University of Colorado Denver -; Neurology, Aurora

95123

PO G.Rodolico, AOU Policlinico-Vittorio Emanuele Catania, Catania

115100

SC Clubul Sanatatii SRL, Campulung Muscel

48109-0666

University of Michigan Health System, Ann Arbor

23219-1901

Virginia Commonwealth University, Richmond

V6T 1Z3

MS Clinical Trials Group, Vancouver

J4V 2J2

Recherche Sepmus Inc., Greenfield Park

H2X 0A9

Centre hospitalier de l'Universite de Montreal (CHUM), Montreal

0112

LTD Helsicore, Tbilisi

0114

Pineo Medical Ecosystem LTD, Tbilisi

0179

S.Khechinashvili Tbilisi State Medical University Clinic Ne, Tbilisi

40-123

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Katowice

04-749

Miedzyleski Szpital Specjalistyczny w Warszawie, Warsaw

00968

San Juan MS Center, Guaynabo

02841

Korea University Anam Hospital - Neurology, Seoul

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Chugai Pharmaceutical

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY