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NCT06298565Recruiting

A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

argenx

Start Date

11/4/2024

Completion Date

6/1/2034

Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment * Have provided appropriate written informed consent Exclusion Criteria: * None

Interventions

BIOLOGICAL

efgartigimod

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Conditions

Myasthenia Gravis

Locations

UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,

San Francisco, California 94143

United States

SFM Clinical Research, LLC

Boca Raton, Florida 33487

United States

University of Florida College of Medicine Jacksonville

Jacksonville Beach, Florida 32209

United States

Medsol Clinical Research Center Inc

Port Charlotte, Florida 33952

United States

BayCare Health System, Inc. St Anthony's Hospital

St. Petersburg, Florida 33705

United States

Prairie Education and Research Cooperative and HSHS Medical Group

O'Fallon, Illinois 62701

United States

University of Iowa

Iowa City, Iowa 52242

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Norton Neuroscience Institute

Louisville, Kentucky 40241

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States

Henry Ford Health System

Detroit, Michigan 48202

United States

Oregon Health and Science University

Portland, Oregon 97239

United States

University of Colorado Hospital

Portland, Oregon 97239

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

National Neuromuscular Research Institute

Austin, Texas 78759

United States

BCN Research, LLC - Gamma Therapeutic Center

Greenfield, Wisconsin 53228

United States

Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III

Linz, 4021

Austria

UZ Leuven (University Hospitals Leuven)

Leuven, 3000

Belgium

Klinikum Altenburger Land GmbH

Altenburg, 04600

Germany

St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

Bochum, 44791

Germany

Klinikum Christophsbad

Göppingen, 7303

Germany

Georg-August-Universität Göttingen

Göttingen, 37073

Germany

Klinikum Oberberg

Gummersbach, 51643

Germany

Universitätsklinikum Jena

Jena, 07747

Germany

Universitätsklinikum Würzburg

Würzburg, 97080

Germany

Piazza OMS - Organizzazione Mondiale della Sanità

Bergamo, 24127

Italy

Ospedale Bellaria - Clinica Neurologica

Bologna, 40139

Italy

Azienda Ospedaliera di Rilievo Nazionale Cardarelli

Naples, 80131

Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, 00168

Italy

Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia

Barcelona, 08035

Spain

Hospital Universitari de Bellvitge

Barcelona, 08907

Spain

Hospital Clinico Universitario San Carlos

Madrid, 28040

Spain

Hospital Universitario Virgen Macarena

Seville, 41009

Spain