A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy

Recruiting now

Conditions studied: Generalized Myasthenia Gravis (gMG), gMG

In brief

This study aims to generate real world evidence (RWE) from Italian clinical practice on the impact of efgartigimod alfa in gMG patients encompassing clinical outcomes and patient reported experiences. The study population will consist in adult patients with a documented diagnosis of gMG who are AChR-antibody positive and for whom the decision of treatment with efgartigimod alfa for gMG has been made independently of study participation as part of routine clinical care. The total study duration will be up to 23 months

Key facts

Study ID

NCT07595653

Run by

argenx

People needed

100

Starts

2026-02-25

Expected to finish

2028-07-01

Last updated by the study team

2026-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years old at signing of informed Consent Form (ICF) and privacy form (PF)
• Documented diagnosis of gMG
• AChR-antibody positive
• The treating physician has decided to initiate efgartigimod alfa as part of routine clinical care and in accordance with product labelling, independently from the study

You may not qualify if…

• Hypersensitivity to the active substance or to any of the excipients listed: sodium dihydrogen phosphate, monohydrate; disodium hydrogen phosphate, anhydrous; arginine hydrochloride; polysorbate 80, hyaluronidase, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 20, sucrose.
• Current or planned participation in an interventional clinical trial.

Where it is running

• Ospedale Generale Regionale F. Miulli — Acquaviva delle Fonti, Italy (enrolling)
• Azienda Ospedaliero Universitaria delle Marche — Ancona, Italy (enrolling)
• A.O.U. Consorziale Policlinico — Bari, Italy (enrolling)
• ASST Papa Giovanni XXIII — Bergamo, Italy (enrolling)
• Ospedale Bellaria — Bologna, Italy (enrolling)
• A.O.U. Renato Dulbecco — Catanzaro, Italy (enrolling)
• A.O.U. Careggi — Florence, Italy (enrolling)
• IRCCS Ospedale Policlinico San Martino — Genova, Italy (enrolling)
• A.O.U. Policlinico G. Martino — Messina, Italy (enrolling)
• IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Italy (enrolling)
• Ospedale San Raffaele — Milan, Italy (enrolling)
• IRCCS Istituto Neurologico Carlo Besta — Milan, Italy (enrolling)
• ASST GOM Niguarda — Milan, Italy (enrolling)
• A.O.U. Policlinico Universitario — Monserrato, Italy (enrolling)
• AORN A. Cardarelli — Naples, Italy (enrolling)
• A.O.U. Università della Campania L. Vanvitelli — Naples, Italy (enrolling)
• A.O.U. San Luigi Gonzaga — Orbassano, Italy (enrolling)
• Azienda Ospedale Università Padova — Padova, Italy (enrolling)
• IRCCS Fondazione Mondino — Pavia, Italy (enrolling)
• Azienda Ospedaliera Perugia — Perugia, Italy (enrolling)
• A.O.U. Pisana — Pisa, Italy (enrolling)
• Ospedale degli Infermi — Rimini, Italy (enrolling)
• Fondazione PTV Policlinico Tor Vergata — Roma, Italy (enrolling)
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma, Italy (enrolling)
• Ospedale Sant'Andrea — Roma, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.