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Spots Global Cancer Trial Database for A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

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Trial Identification

Brief Title: A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

Official Title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis

Study ID: NCT04963270

Interventions

Satralizumab
Placebo

Study Description

Brief Summary: This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Detailed Description:

Keywords

Eligibility

Minimum Age: 12 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

HonorHealth Neurology, Scottsdale, Arizona, United States

Keck School of Medicine of USC, Los Angeles, California, United States

University of California Irvine - Manchester Pavilion, Orange, California, United States

SC3 Research Group, Inc, Pasadena, California, United States

UCSF Benioff Children's Hospital; Department of Pediatrics, San Francisco, California, United States

Childrens National Health Center, Washington, District of Columbia, United States

Medical Faculty Associates Inc., Washington, District of Columbia, United States

University of Florida Jacksonville Physicians Inc. (UFJPI), Jacksonville, Florida, United States

University of Chicago Hospital, Chicago, Illinois, United States

Prairie Education and Research, O'Fallon, Illinois, United States

University of Iowa Hospitals & Clinics; Department of Neurology, Iowa City, Iowa, United States

Massachusetts General Hospital, Boston, Massachusetts, United States

Washington University School of Medicine; Department of Neurology, Saint Louis, Missouri, United States

University at Buffalo / SUNY; UBMD Neurology, Buffalo, New York, United States

South Shore Neurologic Associates P.C., Patchogue, New York, United States

NeuroScience Research Center, Canton, Ohio, United States

The Ohio State University Wexner Medical Center; Department of Neurology, Columbus, Ohio, United States

Hospital Italiano; Neurology, Caba, , Argentina

Hospital Ramos Mejía, Caba, , Argentina

Hospital Britanico, Ciudad Autonoma Bs As, , Argentina

Fundación Scherbovsky; General Department, Mendoza, , Argentina

INECO Neurociencias Orono, Rosario, , Argentina

Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY, San Miguel, , Argentina

Concord Repatriation General Hospital, Concord, New South Wales, Australia

Princess Alexandra Hospital, Woolloongabba, Queensland, Australia

Box Hill Hospital; Department of Neurology, Box Hill, Victoria, Australia

Instituto de Neurologia de Curitiba, Curitiba, PR, Brazil

Hospital Sao Lucas - PUCRS, Porto Alegre, RS, Brazil

Hospital das Clinicas - UNICAMP, Campinas, SP, Brazil

Faculdade de Medicina do ABC - FMABC, Santo Andre, SP, Brazil

Hospital Sao Paulo, Sao Paulo, SP, Brazil

MUCH - Montreal Neurological Institute & Hospital, Montreal, Quebec, Canada

Beijing Tiantan Hospital,Capital Medical University, Beijing City, , China

Beijing Tongren Hospital, Beijing, , China

The First Hospital of Jilin University, Changchun City, , China

Hunan Children's Hospital, Changsha City, , China

Xiangya Hospital Central South University, Changsha City, , China

West China Hospital - Sichuan University, Chengdu City, , China

The Affiliated Hospital of Guizhou Medical University, Guiyang City, , China

Sir Run Run Shaw Hospital, Hangzhou City, , China

The First Affiliated Hospital Of Shandong First Medical University, Jinan City, , China

Huashan Hospital, Fudan University, Shanghai City, , China

Children's Hospital of Fudan University, Shanghai, , China

Tianjin Medical University General Hospital, Tianjin, , China

The First Affiliated Hospital of Wenzhou Medical University, Wenzhou City, , China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology, Wuhan City, , China

Tangdu Hospital, Xi'an City, , China

Aarhus Universitetshospital; Neurologisk Klinik, Aarhus N, , Denmark

Rigshospitalet; Klinik for Nerve- og Muskelsygdomme, København Ø, , Denmark

APHP Raymond Poincare, Garches, , France

Hopital Timone Adultes; Neurologie Mal Neuro Musculaires, Marseille, , France

CHU de Nantes - Hotel Dieu, Nantes, , France

CHU Nice - Hôpital Pasteur 2; SYST NERVEUX PERIPHERIQUE MUSCLE, Nice, , France

Hopital de la Pitie Salpetriere, Paris, , France

CHU Bordeaux, Pessac, , France

St. Josef-Hospital, Klinik für Neurologie, Bochum, , Germany

Universitätsklinikum Essen (AöR); Klinik für Neurologie, Essen, , Germany

Univeristätsklinikum Leipzig; Klinik und Poliklinik für Neurologie, Leipzig, , Germany

Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie, Münster, , Germany

Azienda Ospedaliera A. Cardarelli; Dipartimento medico polispecialistico, Napoli, Campania, Italy

A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS), Roma, Lazio, Italy

Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari, Milano, Lombardia, Italy

Fondazione Istituto Neurologico Mondino IRCCS; SC Neuroncologia e neuroinfiammazione, Pavia, Lombardia, Italy

A.R.N.A.S. Civico Di Cristina Benfratelli; U.O.C. Neurologia con Stroke Unit, Palermo, Sicilia, Italy

Ospedale Cà Foncello; S.C Neurologia, Treviso, Veneto, Italy

Juntendo University Hospital; Neurology, Bunkyo-ku, , Japan

Chiba University Hospital; Neurology, Chiba-shi, Chiba, , Japan

General Hanamaki Hospital; Neurology, Hanamaki, Iwate, , Japan

Hiroshima University Hospital, Hiroshima, , Japan

Sapporo Medical University Hospital; Neurology, Hokkaido, , Japan

NHO Hokkaido Medical Center, Hokkaido, , Japan

Kagawa University Hospital; Neurology, Kagawa, , Japan

St. Marianna University Hospital, Kanagawa, , Japan

Saitama Medical Center; Neurology, Kawagoe-shi, Saitama, , Japan

Nagasaki Kawatana Medical Center; Neurology, Nagasaki, , Japan

International University of Health and Welfare Narita Hospital; Neurology, Narita, Chiba, , Japan

Kindai University Hospital; Neurology, Osaka, , Japan

Osaka Toneyama Medical Center; Neurology, Osaka, , Japan

Dokkyo Medical University Saitama Medical Center; Neurology, Saitama, , Japan

Tokyo Women's Medical University Hospital; Neurology, Shinjuku-ku, , Japan

Seirei Hamamatsu General Hospital, Shizuoka, , Japan

Osaka University Hospital; Neurology, Suita, , Japan

Tokyo Medical And Dental University, Medical Hospital; Neurology, Tokyo, , Japan

Tokyo Medical University Hospital, Tokyo, , Japan

Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of

Pusan National University Yangsan Hospital, Gyeongsangnam-do, , Korea, Republic of

Korea University Anam Hospital, Seoul, , Korea, Republic of

Seoul National University Hospital, Seoul, , Korea, Republic of

Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of

Samsung Medical Center, Seoul, , Korea, Republic of

Amsterdam UMC Location AMC, Amsterdam, , Netherlands

LUMC, Leiden, , Netherlands

Klinika Neurologii Doros?ych, Uniwersyteckie Centrum Kliniczne, Gda?sk, , Poland

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K, Krakow, , Poland

Zespol Poradni Specjalistycznych - Poradnia Neurologiczna; Szpital Uniwersytecki w Krakowie, Kraków, , Poland

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak., Lublin, , Poland

FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk, Krasnojarsk, Russian Federation

Krasnoyarsk State Medical Academy, Krasnoyarsk, Krasnojarsk, Russian Federation

National Center of Social Significant Disease, Sankt-peterburg, Leningrad, Russian Federation

Research Center of Neurology; Neurology Department #5, Moskva, Moskovskaja Oblast, Russian Federation

Leningrad Regional Clinical Hospital, St Petersburg, Sankt Petersburg, Russian Federation

Novosibirsk State Regional Clinical Hospital, Novosibirsk, , Russian Federation

Samara Regional Clinical Hospital named after V.D. Seredavina, Samara, , Russian Federation

Hospital Universitari de Bellvitge; Servicio de Neurologia, L'Hospitalet de Llobregat, Barcelona, Spain

Hospital de Donostia Unidad Demencias; Consultas de Neurología, San Sebastian, Guipuzcoa, Spain

Hospital Universitario Infanta Sofia; Servicio de Neurologia, San Sebastian de los Reyes, Madrid, Spain

Clinica Universitaria de Navarra; Servicio de Neurología, Pamplona, Navarra, Spain

Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia, Barcelona, , Spain

Hospital General Universitario Gregorio Marañon; Servicio de Neurologia, Madrid, , Spain

Clinica Universitaria Navarra; Servicio Neurologia, Madrid, , Spain

Hospital Universitario la Fe; Servicio de Neurologia, Valencia, , Spain

Taipei Veterans General Hospital-Neurology, Taipei, , Taiwan

Chang Gung Medical Foundation Linkou Branch, Taoyuan City, , Taiwan

Hacettepe University Medical Faculty; Neurology, Ankara, , Turkey

Ege University Medical Faculty, Izmir, , Turkey

Kocaeli University Hospital; Department of Neurology, Kocaeli, , Turkey

Ondokuz Mayis Univ. Med. Fac.; Neurology, Samsun, , Turkey

Karadeniz Tecnical Uni. Med. Fac.; Neurology, Trabzon, , Turkey

Contact Details

Name: Clinical Trials

Affiliation: Hoffmann-La Roche

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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