Safety study of efgartigimod in adults with myasthenia gravis
Observes safety of efgartigimod in adults with generalized myasthenia gravis who take it.
Plain-language title generated from the registry record
Registry title: A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Key facts
- Where
- Bergamo, Bologna, Naples, Pisa, and Roma, ItalySee the 5 sites
Where in Italy
- Piazza OMS - Organizzazione Mondiale della SanitàBergamo, ItalyTaking people
- Ospedale Bellaria - Clinica NeurologicaBologna, ItalyTaking people
- Azienda Ospedaliera di Rilievo Nazionale CardarelliNaples, ItalyTaking people
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- argenx
- Trial code
- NCT06298565
- Record updated
- 17 February 2026
- Original description
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.Read full original descriptionShow less
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
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.
Inclusion: 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: None.