Actively Recruiting

Age: 18Years +
All Genders
NCT06298565

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

Led by argenx · Updated on 2026-02-17

680

Participants Needed

35

Research Sites

499 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients diagnosed with generalized myasthenia gravis (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
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 35 locations

1

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

San Francisco, California, United States, 94143

Actively Recruiting

2

SFM Clinical Research, LLC

Boca Raton, Florida, United States, 33487

Actively Recruiting

3

University of Florida College of Medicine Jacksonville

Jacksonville Beach, Florida, United States, 32209

Actively Recruiting

4

Medsol Clinical Research Center Inc

Port Charlotte, Florida, United States, 33952

Actively Recruiting

5

BayCare Health System, Inc. St Anthony's Hospital

St. Petersburg, Florida, United States, 33705

Actively Recruiting

6

Prairie Education and Research Cooperative and HSHS Medical Group

O'Fallon, Illinois, United States, 62701

Actively Recruiting

7

University of Iowa

Iowa City, Iowa, United States, 52242

Actively Recruiting

8

University of Kansas Medical Center

Kansas City, Kansas, United States, 66160

Actively Recruiting

9

Norton Neuroscience Institute

Louisville, Kentucky, United States, 40241

Actively Recruiting

10

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

11

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

12

Henry Ford Health System

Detroit, Michigan, United States, 48202

Actively Recruiting

13

Oregon Health and Science University

Portland, Oregon, United States, 97239

Actively Recruiting

14

University of Colorado Hospital

Portland, Oregon, United States, 97239

Actively Recruiting

15

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

16

National Neuromuscular Research Institute

Austin, Texas, United States, 78759

Actively Recruiting

17

BCN Research, LLC - Gamma Therapeutic Center

Greenfield, Wisconsin, United States, 53228

Actively Recruiting

18

Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III

Linz, Austria, 4021

Actively Recruiting

19

UZ Leuven (University Hospitals Leuven)

Leuven, Belgium, 3000

Actively Recruiting

20

Klinikum Altenburger Land GmbH

Altenburg, Germany, 04600

Actively Recruiting

21

St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum

Bochum, Germany, 44791

Actively Recruiting

22

Klinikum Christophsbad

Göppingen, Germany, 7303

Actively Recruiting

23

Georg-August-Universität Göttingen

Göttingen, Germany, 37073

Actively Recruiting

24

Klinikum Oberberg

Gummersbach, Germany, 51643

Actively Recruiting

25

Universitätsklinikum Jena

Jena, Germany, 07747

Actively Recruiting

26

Universitätsklinikum Würzburg

Würzburg, Germany, 97080

Actively Recruiting

27

Piazza OMS - Organizzazione Mondiale della Sanità

Bergamo, Italy, 24127

Actively Recruiting

28

Ospedale Bellaria - Clinica Neurologica

Bologna, Italy, 40139

Actively Recruiting

29

Azienda Ospedaliera di Rilievo Nazionale Cardarelli

Naples, Italy, 80131

Actively Recruiting

30

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy, 56126

Actively Recruiting

31

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Roma, Italy, 00168

Actively Recruiting

32

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

Barcelona, Spain, 08035

Actively Recruiting

33

Hospital Universitari de Bellvitge

Barcelona, Spain, 08907

Actively Recruiting

34

Hospital Clinico Universitario San Carlos

Madrid, Spain, 28040

Actively Recruiting

35

Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Actively Recruiting

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Research Team

S

Sabine Coppieters, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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