A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: efgartigimod.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, Germany, Italy +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Biological efgartigimod
efgartigimod
Primary outcome measures
- The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod [Time frame: up to 10 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 17 centers
- UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center - Brain Tumor Center — San Francisco
- SFM Clinical Research, LLC — Boca Raton
- University of Florida College of Medicine Jacksonville — Jacksonville Beach
- Medsol Clinical Research Center Inc — Port Charlotte
- BayCare Health System, Inc. St Anthony's Hospital — St. Petersburg
- Prairie Education and Research Cooperative and HSHS Medical Group — O'Fallon
- University of Iowa — Iowa City
- University of Kansas Medical Center — Kansas City
- … and 9 more centers
Germany · 7 centers
- Klinikum Altenburger Land GmbH — Altenburg
- St. Josef-Hospital Klinikum der Ruhr Universitaet Bochum — Bochum
- Klinikum Christophsbad — Göppingen
- Georg-August-Universität Göttingen — Göttingen
- Klinikum Oberberg — Gummersbach
- Universitätsklinikum Jena — Jena
- Universitätsklinikum Würzburg — Würzburg
Italy · 5 centers
- Piazza OMS - Organizzazione Mondiale della Sanità — Bergamo
- Ospedale Bellaria - Clinica Neurologica — Bologna
- Azienda Ospedaliera di Rilievo Nazionale Cardarelli — Naples
- Azienda Ospedaliero Universitaria Pisana — Pisa
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Spain · 4 centers
- Hospital Universitari Vall d'Hebron, Unitat de Malalties Neuromusculars, Servei de Neurolo — Barcelona
- Hospital Universitari de Bellvitge — Barcelona
- Hospital Clinico Universitario San Carlos — Madrid
- Hospital Universitario Virgen Macarena — Seville
Austria · 1 center
- Kepler Universitätsklinikum, Universitätsklinik für Neurologie, Med Campus III — Linz
Belgium · 1 center
- UZ Leuven (University Hospitals Leuven) — Leuven
Identifiers
NCT: NCT06298565 · ARGX-113-PASS-2208