A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy (NCT07595653) — Italy Trial Details

Condition(s) studied

Generalized Myasthenia Gravis (gMG)gMG

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

No

Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Changes in MG-ADL scores from baseline — Up to 12 months
The Myasthenia Gravis Activities of Living (MG-ADL) scale is an 8-item patient-reported scale that measures MG symptoms and functional status across 4 domains. The total score ranges from 0 to 24, with higher scores indicating greater disability.
Percentage of patients achieving MSE — Up to 12 months
Minimal Symptom Expression (MSE) is defined as an MG-ADL score ≤ 1

Trial sites (30)

Facility	City	Region	Status
Ospedale Generale Regionale F. Miulli	Acquaviva delle Fonti	Italy	Recruiting
Azienda Ospedaliero Universitaria delle Marche	Ancona	Italy	Recruiting
A.O.U. Consorziale Policlinico	Bari	Italy	Recruiting
ASST Papa Giovanni XXIII	Bergamo	Italy	Recruiting
Ospedale Bellaria	Bologna	Italy	Recruiting
A.O.U. Renato Dulbecco	Catanzaro	Italy	Recruiting
A.O.U. Careggi	Florence	Italy	Recruiting
IRCCS Ospedale Policlinico San Martino	Genova	Italy	Recruiting
A.O.U. Policlinico G. Martino	Messina	Italy	Recruiting
IRCCS Cà Granda Ospedale Maggiore Policlinico	Milan	Italy	Recruiting
Ospedale San Raffaele	Milan	Italy	Recruiting
IRCCS Istituto Neurologico Carlo Besta	Milan	Italy	Recruiting
ASST GOM Niguarda	Milan	Italy	Recruiting
A.O.U. Policlinico Universitario	Monserrato	Italy	Recruiting
AORN A. Cardarelli	Naples	Italy	Recruiting
A.O.U. Università della Campania L. Vanvitelli	Naples	Italy	Recruiting
A.O.U. San Luigi Gonzaga	Orbassano	Italy	Recruiting
Azienda Ospedale Università Padova	Padova	Italy	Recruiting
IRCCS Fondazione Mondino	Pavia	Italy	Recruiting
Azienda Ospedaliera Perugia	Perugia	Italy	Recruiting
A.O.U. Pisana	Pisa	Italy	Recruiting
Ospedale degli Infermi	Rimini	Italy	Recruiting
Fondazione PTV Policlinico Tor Vergata	Roma	Italy	Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Italy	Recruiting
Ospedale Sant'Andrea	Roma	Italy	Recruiting
A.O.U. San Giovanni di Dio e Ruggi D'Aragona	Salerno	Italy	Recruiting
IRCCS Fondazione Casa Sollievo della Sofferenza	San Giovanni Rotondo	Italy	Recruiting
A.O.U. Sassari	Sassari	Italy	Recruiting
Ospedale Ca' Foncello	Treviso	Italy	Recruiting
AOUI Verona - Policlinico G.B. Rossi	Verona	Italy	Recruiting

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