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Taking people in ItalyNo phase

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, and Verona, ItalySee the 30 sites

Where in Italy

  • Ospedale Generale Regionale " F.Miulli "Acquaviva delle Fonti, ItalyTaking people
  • Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyTaking people
  • A.O.U. Consorziale PoliclinicoBari, ItalyTaking people
  • Asst Papa Giovanni XXIIIBergamo, ItalyTaking people
  • Ospedale BellariaBologna, ItalyTaking people
  • A.O.U. Renato DulbeccoCatanzaro, ItalyTaking people
  • A.O.U CareggiFlorence, ItalyTaking people
  • IRCCS Ospedale Policlinico San MartinoGenova, ItalyTaking people
  • A.O.U. Policlinico G. MartinoMessina, ItalyTaking people
  • ASST GOM NiguardaMilan, ItalyTaking people
  • IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
  • IRCCS Istituto Neurologico Carlo BestaMilan, ItalyTaking people
  • Ospedale San RaffaeleMilan, ItalyTaking people
  • A.O.U. Policlinico UniversitarioMonserrato, ItalyTaking people
  • A.O.U. Università della Campania L. VanvitelliNaples, ItalyTaking people
  • AORN A. CardarelliNaples, ItalyTaking people
  • A.O.U. San Luigi GonzagaOrbassano, ItalyTaking people
  • Azienda Ospedale Universita PadovaPadova, ItalyTaking people
  • IRCCS Fondazione MondinoPavia, ItalyTaking people
  • Azienda Ospedaliera PerugiaPerugia, ItalyTaking people
  • A.O.U. PisanaPisa, ItalyTaking people
  • Ospedale degli InfermiRimini, ItalyTaking people
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyTaking people
  • Fondazione PTV - POLICLINICO TOR VERGATARoma, ItalyTaking people
  • Ospedale Sant'AndreaRoma, ItalyTaking people
  • A.O.U. San Giovanni di Dio e Ruggì D'AragonaSalerno, ItalyTaking people
  • IRCCS Fondazione Casa Sollievo della SofferenzaSan Giovanni Rotondo, ItalyTaking people
  • A.O.U. SassariSassari, ItalyTaking people
  • Ospedale Ca' FoncelloTreviso, ItalyTaking people
  • AOUI Verona - Policlinico "G.B. Rossi"Verona, ItalyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
argenx
Trial code
NCT07595653
Record updated
19 May 2026
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.

ClinicalTrials.gov NCT07595653

Under construction, not live – A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy (NCT07595653) – Frontlight Research