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

Status: Recruiting
Location: See all (35) locations...
Intervention Type: Biological
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,
RECRUITING
San Francisco
Florida
SFM Clinical Research, LLC
RECRUITING
Boca Raton
University of Florida College of Medicine Jacksonville
RECRUITING
Jacksonville Beach
Medsol Clinical Research Center Inc
RECRUITING
Port Charlotte
BayCare Health System, Inc. St Anthony's Hospital
RECRUITING
St. Petersburg
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Prairie Education and Research Cooperative and HSHS Medical Group
RECRUITING
O'fallon
Kansas
University of Kansas Medical Center
RECRUITING
Kansas City
Kentucky
Norton Neuroscience Institute
RECRUITING
Louisville
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Michigan
Henry Ford Health System
RECRUITING
Detroit
Oregon
Oregon Health and Science University
RECRUITING
Portland
University of Colorado Hospital
RECRUITING
Portland
South Carolina
Medical University of South Carolina
RECRUITING
Charleston
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
Wisconsin
BCN Research, LLC - Gamma Therapeutic Center
RECRUITING
Greenfield
Other Locations
Austria
Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III
RECRUITING
Linz
Belgium
UZ Leuven (University Hospitals Leuven)
RECRUITING
Leuven
Germany
Klinikum Altenburger Land GmbH
RECRUITING
Altenburg
St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum
RECRUITING
Bochum
Klinikum Christophsbad
RECRUITING
Göppingen
Georg-August-Universität Göttingen
RECRUITING
Göttingen
Klinikum Oberberg
RECRUITING
Gummersbach
Universitätsklinikum Jena
RECRUITING
Jena
Universitätsklinikum Würzburg
RECRUITING
Würzburg
Italy
Piazza OMS - Organizzazione Mondiale della Sanità
RECRUITING
Bergamo
Ospedale Bellaria - Clinica Neurologica
RECRUITING
Bologna
Azienda Ospedaliera di Rilievo Nazionale Cardarelli
RECRUITING
Napoli
Azienda Ospedaliero Universitaria Pisana
RECRUITING
Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Roma
Spain
Hospital Universitari de Bellvitge
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia
RECRUITING
Barcelona
Hospital Clinico Universitario San Carlos
RECRUITING
Madrid
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Contact Information
Primary
Sabine Coppieters, MD
Clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-11-04
Estimated Completion Date: 2034-06
Participants
Target number of participants: 680
Treatments
efgartigimod cohort
patients treated with efgartigimod
non-efgartigimod cohort
patient treated with other MG medication
Related Therapeutic Areas
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov

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