A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
Key facts
- Where
- Acquaviva delle Fonti, Ancona, Bari, Bergamo, Bologna, Catanzaro, Florence, Genova, Messina, Milan, Monserrato, Naples, Orbassano, Padova, Pavia, Perugia, Pisa, Rimini, Roma, Salerno, San Giovanni Rotondo, Sassari, Treviso és Verona, OlaszországSee the 30 sites
Where in Olaszország
- Ospedale Generale Regionale " F.Miulli "Acquaviva delle Fonti, OlaszországTaking people
- Azienda Ospedaliero-Universitaria delle MarcheAncona, OlaszországTaking people
- A.O.U. Consorziale PoliclinicoBari, OlaszországTaking people
- Asst Papa Giovanni XXIIIBergamo, OlaszországTaking people
- Ospedale BellariaBologna, OlaszországTaking people
- A.O.U. Renato DulbeccoCatanzaro, OlaszországTaking people
- A.O.U CareggiFlorence, OlaszországTaking people
- IRCCS Ospedale Policlinico San MartinoGenova, OlaszországTaking people
- A.O.U. Policlinico G. MartinoMessina, OlaszországTaking people
- ASST GOM NiguardaMilan, OlaszországTaking people
- IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, OlaszországTaking people
- IRCCS Istituto Neurologico Carlo BestaMilan, OlaszországTaking people
- Ospedale San RaffaeleMilan, OlaszországTaking people
- A.O.U. Policlinico UniversitarioMonserrato, OlaszországTaking people
- A.O.U. Università della Campania L. VanvitelliNaples, OlaszországTaking people
- AORN A. CardarelliNaples, OlaszországTaking people
- A.O.U. San Luigi GonzagaOrbassano, OlaszországTaking people
- Azienda Ospedale Universita PadovaPadova, OlaszországTaking people
- IRCCS Fondazione MondinoPavia, OlaszországTaking people
- Azienda Ospedaliera PerugiaPerugia, OlaszországTaking people
- A.O.U. PisanaPisa, OlaszországTaking people
- Ospedale degli InfermiRimini, OlaszországTaking people
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, OlaszországTaking people
- Fondazione PTV - POLICLINICO TOR VERGATARoma, OlaszországTaking people
- Ospedale Sant'AndreaRoma, OlaszországTaking people
- A.O.U. San Giovanni di Dio e Ruggì D'AragonaSalerno, OlaszországTaking people
- IRCCS Fondazione Casa Sollievo della SofferenzaSan Giovanni Rotondo, OlaszországTaking people
- A.O.U. SassariSassari, OlaszországTaking people
- Ospedale Ca' FoncelloTreviso, OlaszországTaking people
- AOUI Verona - Policlinico "G.B. Rossi"Verona, OlaszországTaking 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
- NCT07595653
- Record updated
- 2026. május 19.
- Original description
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.Read full original descriptionShow less
Non-interventional, Longitudinal Hybrid Data Sources Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
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
Inclusion: 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.
Exclusion: 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.