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NCT06298565Recruiting

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

Source: ClinicalTrials.gov · Last updated 17 Feb 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
680 (estimated)
First submitted
1 Mar 2024
Start date
Nov 2024
Primary completion date
Jun 2034
Lead sponsor
argenx
NCT number
NCT06298565

What you commit to

  • Study type: Observational
  • Planned participants: 680
  • From Nov 2024 to the primary completion date, Jun 2034
  • 35 sites in 6 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • None

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III
Coordinator of this site? Confirm its status
LinzAustriaRecruiting
UZ Leuven (University Hospitals Leuven)
Coordinator of this site? Confirm its status
LeuvenBelgiumRecruiting
Klinikum Altenburger Land GmbH
Coordinator of this site? Confirm its status
AltenburgGermanyRecruiting
St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum
Coordinator of this site? Confirm its status
BochumGermanyRecruiting
Klinikum Christophsbad
Coordinator of this site? Confirm its status
GöppingenGermanyRecruiting
Georg-August-Universität Göttingen
Coordinator of this site? Confirm its status
GöttingenGermanyRecruiting
Klinikum Oberberg
Coordinator of this site? Confirm its status
GummersbachGermanyRecruiting
Universitätsklinikum Jena
Coordinator of this site? Confirm its status
JenaGermanyRecruiting
Universitätsklinikum Würzburg
Coordinator of this site? Confirm its status
WürzburgGermanyRecruiting
Hospital Universitari de Bellvitge
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurologia
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Clínico Universitario San Carlos
Coordinator of this site? Confirm its status
MadridSpainRecruiting
Hospital Universitario Virgen Macarena
Coordinator of this site? Confirm its status
SevilleSpainRecruiting
Piazza OMS - Organizzazione Mondiale della Sanità
Coordinator of this site? Confirm its status
BergamoItalyRecruiting
Ospedale Bellaria - Clinica Neurologica
Coordinator of this site? Confirm its status
BolognaItalyRecruiting
Azienda Ospedaliera di Rilievo Nazionale Cardarelli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomaItalyRecruiting
National Neuromuscular Research Institute
Coordinator of this site? Confirm its status
AustinUnited StatesRecruiting
SFM Clinical Research LLC
Coordinator of this site? Confirm its status
Boca RatonUnited StatesRecruiting
Massachusetts General Hospital
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BostonUnited StatesRecruiting
Beth Israel Deaconess Medical Center
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BostonUnited StatesRecruiting
Medical University of South Carolina
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CharlestonUnited StatesRecruiting
Henry Ford Health System
Coordinator of this site? Confirm its status
DetroitUnited StatesRecruiting
BCN Research, LLC - Gamma Therapeutic Center
Coordinator of this site? Confirm its status
GreenfieldUnited StatesRecruiting
University of Iowa
Coordinator of this site? Confirm its status
Iowa CityUnited StatesRecruiting
University of Florida College of Medicine Jacksonville
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Jacksonville BeachUnited StatesRecruiting
University of Kansas Medical Center
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Kansas CityUnited StatesRecruiting
Norton Neuroscience Institute
Coordinator of this site? Confirm its status
LouisvilleUnited StatesRecruiting
Prairie Education and Research Cooperative and HSHS Medical Group
Coordinator of this site? Confirm its status
O'FallonUnited StatesRecruiting
Medsol Clinical Research Center Inc
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Port CharlotteUnited StatesRecruiting
Oregon Health and Science University
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PortlandUnited StatesRecruiting
University of Colorado Hospital
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PortlandUnited StatesRecruiting
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center,
Coordinator of this site? Confirm its status
San FranciscoUnited StatesRecruiting
BayCare Health System, Inc. St Anthony's Hospital
Coordinator of this site? Confirm its status
St. PetersburgUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.