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RECRUITING
NCT06298565

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

Sponsor: argenx

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

680

Start Date

2024-11-04

Completion Date

2034-06

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

BIOLOGICAL

efgartigimod

efgartigimod

Locations (35)

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

San Francisco, California, United States

SFM Clinical Research, LLC

Boca Raton, Florida, United States

University of Florida College of Medicine Jacksonville

Jacksonville Beach, Florida, United States

Medsol Clinical Research Center Inc

Port Charlotte, Florida, United States

BayCare Health System, Inc. St Anthony's Hospital

St. Petersburg, Florida, United States

Prairie Education and Research Cooperative and HSHS Medical Group

O'Fallon, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Norton Neuroscience Institute

Louisville, Kentucky, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Oregon Health and Science University

Portland, Oregon, United States

University of Colorado Hospital

Portland, Oregon, United States

Medical University of South Carolina

Charleston, South Carolina, United States

National Neuromuscular Research Institute

Austin, Texas, United States

BCN Research, LLC - Gamma Therapeutic Center

Greenfield, Wisconsin, United States

Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III

Linz, Austria

UZ Leuven (University Hospitals Leuven)

Leuven, Belgium

Klinikum Altenburger Land GmbH

Altenburg, Germany

St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

Bochum, Germany

Klinikum Christophsbad

Göppingen, Germany

Georg-August-Universität Göttingen

Göttingen, Germany

Klinikum Oberberg

Gummersbach, Germany

Universitätsklinikum Jena

Jena, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Piazza OMS - Organizzazione Mondiale della Sanità

Bergamo, Italy

Ospedale Bellaria - Clinica Neurologica

Bologna, Italy

Azienda Ospedaliera di Rilievo Nazionale Cardarelli

Naples, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy

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

Barcelona, Spain

Hospital Universitari de Bellvitge

Barcelona, Spain

Hospital Clinico Universitario San Carlos

Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Spain