Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Myasthenia Gravis Generalised
Sarcopenia
Treatment
Satralizumab
Placebo
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Signed Informed Consent Form
For adolescent patients: Informed Consent Form for study participation signed by theparents or a legal guardian, and patient assent obtained, as per local requirements
Ability to comply with the study protocol procedures
Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
A total MG-ADL score of ≥ 5 points at screening with more than 50% of this scoreattributed to non-ocular items
MGFA severity Class II-IV
Ongoing gMG treatment at a stable dose
For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during thetreatment period and for at least 3 months after the final dose of satralizumab.
Exclusion
Exclusion Criteria:
History of thymectomy within 12 months prior to screening
Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3months prior to screening
Known disease other than gMG that would interfere with the course and conduct of thestudy
Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
Evidence of latent or active tuberculosis (excluding patients receivingchemoprophylaxis for latent tuberculosis infection)
Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
Pregnant or breastfeeding, or intending to become pregnant during the study orwithin 3 months after the last dose
Study Design
Connect with a study center
Hospital Italiano
Caba, C1199ABA
ArgentinaSite Not Available
Hospital Italiano; Neurology
Caba, C1199ABA
ArgentinaSite Not Available
Hospital Ramos Mejía
Caba, C1221ADC
ArgentinaSite Not Available
Hospital Britanico
Ciudad Autonoma Bs As, C1280AEB
ArgentinaSite Not Available
Fundación Scherbovsky
Mendoza, M5500AYB
ArgentinaSite Not Available
Fundación Scherbovsky; General Department
Mendoza, M5500AYB
ArgentinaSite Not Available
INECO Neurociencias Orono
Rosario, S2000DTC
ArgentinaSite Not Available
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
San Miguel, T4000AXL
ArgentinaSite Not Available
Concord Repatriation General Hospital
Concord, New South Wales 2139
AustraliaSite Not Available
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Box Hill Hospital; Department of Neurology
Box Hill, Victoria 3128
AustraliaSite Not Available
Instituto de Neurologia de Curitiba
Curitiba, PR 81210-310
BrazilSite Not Available
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande Do Sul 90610-000
BrazilSite Not Available
Hospital das Clinicas - UNICAMP
Campinas, São Paulo 13083-887
BrazilSite Not Available
Faculdade de Medicina do ABC - FMABC
Santo Andre, São Paulo 09060-650
BrazilSite Not Available
Hospital Sao Paulo
Sao Paulo, São Paulo 04037-002
BrazilSite Not Available
University of Calgary; Heritage Medical Research Clinic
Calgary, Alberta T2N 4Z6
CanadaSite Not Available
Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaSite Not Available
MUCH - Montreal Neurological Institute & Hospital
Montreal, Quebec H3A 2B4
CanadaSite Not Available
Beijing Tiantan Hospital,Capital Medical University
Beijing, DUMMY_VALUE
ChinaSite Not Available
Beijing Tongren Hospital
Beijing, 100730
ChinaSite Not Available
Beijing Tiantan Hospital,Capital Medical University
Beijing City, 100050
ChinaSite Not Available
The First Hospital of Jilin University
Changchun City, 130021
ChinaSite Not Available
Hunan Children's Hospital
Changsha City, 410007
ChinaSite Not Available
Xiangya Hospital Central South University
Changsha City, 410008
ChinaSite Not Available
West China Hospital - Sichuan University
Chengdu City, 610047
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang, DUMMY_VALUE
ChinaSite Not Available
The Affiliated Hospital of Guizhou Medical University
Guiyang City, 550000
ChinaSite Not Available
Sir Run Run Shaw Hospital
Hangzhou, 310016
ChinaSite Not Available
Sir Run Run Shaw Hospital
Hangzhou City, 310018
ChinaSite Not Available
The First Affiliated Hospital Of Shandong First Medical University
Jinan, DUMMY_VALUE
ChinaSite Not Available
The First Affiliated Hospital Of Shandong First Medical University
Jinan City, 250014
ChinaSite Not Available
Children's Hospital of Fudan University
Shanghai, 201102
ChinaSite Not Available
Huashan Hospital, Fudan University
Shanghai City, 200040
ChinaSite Not Available
The First Hospital of Shanxi Medical University
Taiyuan, 030001
ChinaSite Not Available
Tianjin Medical University General Hospital
Tianjin, 300052
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou City, 325035
ChinaSite Not Available
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan City, 430030
ChinaSite Not Available
Tangdu Hospital
Xi'an,
ChinaSite Not Available
Tangdu Hospital
Xi'an City, 710038
ChinaSite Not Available
Aarhus Universitetshospital
Aarhus N, 8200
DenmarkSite Not Available
Aarhus Universitetshospital; Neurologisk Klinik
Aarhus N, 8200
DenmarkSite Not Available
Rigshospitalet
København Ø, 2100
DenmarkSite Not Available
Rigshospitalet; Klinik for Nerve- og Muskelsygdomme
København Ø, 2100
DenmarkSite Not Available
CHU Bordeaux
Bordeaux cedex, 33076
FranceSite Not Available
APHP Raymond Poincare
Garches, 92380
FranceSite Not Available
Hopital Timone Adultes
Marseille, 13385
FranceSite Not Available
Hopital Timone Adultes; Neurologie Mal Neuro Musculaires
Marseille, 13385
FranceSite Not Available
CHU de Nantes - Hotel Dieu
Nantes, 44093
FranceSite Not Available
CHU Nice - Hôpital Pasteur 2
Nice, 06000
FranceSite Not Available
CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE
Nice, 06000
FranceSite Not Available
Hopital de la Pitie Salpetriere
Paris, 75013
FranceSite Not Available
CHU Bordeaux
Pessac, 33604
FranceSite Not Available
St. Josef-Hospital, Klinik für Neurologie
Bochum, 44791
GermanySite Not Available
Universitätsklinikum Essen (AöR)
Essen, 45147
GermanySite Not Available
Universitätsklinikum Essen (AöR); Klinik für Neurologie
Essen, 45147
GermanySite Not Available
Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie
Leipzig, 04103
GermanySite Not Available
Universitätsklinikum Münster
Münster, 48149
GermanySite Not Available
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster, 48149
GermanySite Not Available
Azienda Ospedaliera A. Cardarelli
Napoli, Campania 80131
ItalySite Not Available
Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico
Napoli, Campania 80131
ItalySite Not Available
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
Roma, Lazio 00189
ItalySite Not Available
Fond. Istituto Neurologico C.Besta
Milano, Lombardia 20133
ItalySite Not Available
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Milano, Lombardia 20133
ItalySite Not Available
Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione
Pavia, Lombardia 27100
ItalySite Not Available
A.R.N.A.S. Civico Di Cristina Benfratelli
Palermo, Sicilia 90127
ItalySite Not Available
A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit
Palermo, Sicilia 90127
ItalySite Not Available
Ospedale Cà Foncello
Treviso, Veneto 31100
ItalySite Not Available
Ospedale Cà Foncello; S.C Neurologia
Treviso, Veneto 31100
ItalySite Not Available
Juntendo University Hospital
Bunkyo-ku, 113-8431
JapanSite Not Available
Juntendo University Hospital; Neurology
Bunkyo-ku, 113-8431
JapanSite Not Available
Chiba University Hospital
Chiba-shi, Chiba, 260-8677
JapanSite Not Available
Chiba University Hospital; Neurology
Chiba-shi, Chiba, 260-8677
JapanSite Not Available
General Hanamaki Hospital
Hanamaki, Iwate, 025-0082
JapanSite Not Available
General Hanamaki Hospital; Neurology
Hanamaki, Iwate, 025-0082
JapanSite Not Available
Hiroshima University Hospital
Hiroshima, 734-8551
JapanSite Not Available
NHO Hokkaido Medical Center
Hokkaido, 063-0005
JapanSite Not Available
Sapporo Medical University Hospital
Hokkaido, 060-8543
JapanSite Not Available
Sapporo Medical University Hospital; Neurology
Hokkaido, 060-8543
JapanSite Not Available
Kagawa University Hospital; Neurology
Kagawa, 761-0793
JapanSite Not Available
St. Marianna University Hospital
Kanagawa, 216-8511
JapanSite Not Available
Saitama Medical Center; Neurology
Kawagoe-shi, Saitama, 350-8550
JapanSite Not Available
Nagasaki Kawatana Medical Center; Neurology
Nagasaki, 859-3615
JapanSite Not Available
International University of Health and Welfare Narita Hospital
Narita, Chiba, 286-0124
JapanSite Not Available
International University of Health and Welfare Narita Hospital; Neurology
Narita, Chiba, 286-0124
JapanSite Not Available
Kindai University Hospital
Osaka, 589-8511
JapanSite Not Available
Kindai University Hospital; Neurology
Osaka, 589-8511
JapanSite Not Available
Osaka Toneyama Medical Center; Neurology
Osaka,
JapanSite Not Available
Dokkyo Medical University Saitama Medical Center; Neurology
Saitama, 343-8555
JapanSite Not Available
Tokyo Women's Medical University Hospital; Neurology
Shinjuku-ku, 162-8666
JapanSite Not Available
Seirei Hamamatsu General Hospital
Shizuoka, 430-8558
JapanSite Not Available
Osaka University Hospital
Suita, 565-0871
JapanSite Not Available
Osaka University Hospital; Neurology
Suita, 565-0871
JapanSite Not Available
Tokyo Medical And Dental University, Medical Hospital
Tokyo, 113-8519
JapanSite Not Available
Tokyo Medical And Dental University, Medical Hospital; Neurology
Tokyo, 113-8519
JapanSite Not Available
Tokyo Medical University Hospital
Tokyo, 160-0023
JapanSite Not Available
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofSite Not Available
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Korea, Republic ofSite Not Available
Korea University Anam Hospital
Seoul, 02841
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, (0)6351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Amsterdam UMC Location AMC
Amsterdam, 1105 AZ
NetherlandsSite Not Available
LUMC
Leiden, 2333 ZA
NetherlandsSite Not Available
Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne
Gda?sk, 80-952
PolandSite Not Available
Klinika Neurologii Dorosłych, Uniwersyteckie Centrum Kliniczne
Gdańsk, 80-952
PolandSite Not Available
Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
Krakow, 31-505
PolandSite Not Available
Zespol Poradni Specjalistycznych - Poradnia Neurologiczna
Kraków, 31-503
PolandSite Not Available
Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie
Kraków, 31-503
PolandSite Not Available
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, 20-016
PolandSite Not Available
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Krasnojarsk 660037
Russian FederationSite Not Available
Krasnoyarsk State Medical Academy
Krasnoyarsk, Krasnojarsk 660022
Russian FederationSite Not Available
National Center of Social Significant Disease
Sankt-peterburg, Leningrad 197110
Russian FederationSite Not Available
Research Center of Neurology; Neurology Department #5
Moskva, Moskovskaja Oblast 125367
Russian FederationSite Not Available
Leningrad Regional Clinical Hospital
St Petersburg, Sankt Petersburg 194291
Russian FederationSite Not Available
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087
Russian FederationSite Not Available
Samara Regional Clinical Hospital named after V.D. Seredavina
Samara, 443095
Russian FederationSite Not Available
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Hospital de Donostia Unidad Demencias; Consultas de Neurología
San Sebastian, Guipuzcoa 20080
SpainSite Not Available
Hospital Universitario Infanta Sofia; Servicio de Neurologia
San Sebastian de los Reyes, Madrid 28702
SpainSite Not Available
Clinica Universitaria de Navarra
Pamplona, Navarra 31008
SpainSite Not Available
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarra 31008
SpainSite Not Available
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
SpainSite Not Available
Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
Barcelona, 08041
SpainSite Not Available
Clinica Universitaria Navarra; Servicio Neurologia
Madrid, 28027
SpainSite Not Available
Hospital General Universitario Gregorio Marañon; Servicio de Neurologia
Madrid, 28007
SpainSite Not Available
Hospital Universitario la Fe
Valencia, 46026
SpainSite Not Available
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, 46026
SpainSite Not Available
Taipei Veterans General Hospital-Neurology
Taipei, 11217
TaiwanSite Not Available
Chang Gung Medical Foundation Linkou Branch
Taoyuan City, 333
TaiwanSite Not Available
Hacettepe University Medical Faculty
Ankara, 06100
TurkeySite Not Available
Hacettepe University Medical Faculty; Neurology
Ankara, 06100
TurkeySite Not Available
Ege University Medical Faculty
Izmir, 35100
TurkeySite Not Available
Kocaeli University Hospital
Kocaeli, 41380
TurkeySite Not Available
Kocaeli University Hospital; Department of Neurology
Kocaeli, 41380
TurkeySite Not Available
Ondokuz Mayis Univ. Med. Fac.
Samsun, 55139
TurkeySite Not Available
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, 55139
TurkeySite Not Available
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon, 61080
TurkeySite Not Available
HonorHealth Neurology
Scottsdale, Arizona 85251
United StatesSite Not Available
Keck School of Medicine of USC
Los Angeles, California 90033
United StatesSite Not Available
University of California Irvine - Manchester Pavilion
Orange, California 92868
United StatesSite Not Available
SC3 Research Group, Inc
Pasadena, California 91105
United StatesSite Not Available
UCSF Benioff Children's Hospital; Department of Pediatrics
San Francisco, California 94143
United StatesSite Not Available
Childrens National Health Center
Washington, District of Columbia 20010
United StatesSite Not Available
Medical Faculty Associates Inc.
Washington, District of Columbia 20037
United StatesSite Not Available
University of Florida Jacksonville Physicians Inc. (UFJPI)
Jacksonville, Florida 32209
United StatesSite Not Available
University of Chicago Hospital
Chicago, Illinois 60637
United StatesSite Not Available
Prairie Education and Research
O'Fallon, Illinois 62269
United StatesSite Not Available
University of Iowa Hospitals & Clinics; Department of Neurology
Iowa City, Iowa 52242
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114-2621
United StatesSite Not Available
Washington University School of Medicine; Department of Neurology
Saint Louis, Missouri 63110
United StatesSite Not Available
University at Buffalo / SUNY; UBMD Neurology
Buffalo, New York 14203
United StatesSite Not Available
Neurological Institute of New York
New York, New York 10032
United StatesSite Not Available
South Shore Neurologic Associates P.C.
Patchogue, New York 11772
United StatesSite Not Available
NeuroScience Research Center
Canton, Ohio 44718
United StatesSite Not Available
The Ohio State University Wexner Medical Center; Department of Neurology
Columbus, Ohio 43221
United StatesSite Not Available
Mercy Neurology Clinic
Moore, Oklahoma 73160
United StatesSite Not Available

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