NCT07595653Recruiting
A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
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
Source: ClinicalTrials.gov · Last updated 19 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 9 Mar 2026
- Start date
- 25 Feb 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- argenx
- Diseases
- Myasthenia gravis
- NCT number
- NCT07595653
What you commit to
- Study type: Observational
- Planned participants: 100
- From 25 Feb 2026 to the primary completion date, 30 Nov 2027
- 30 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- 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.
Other
- Current or planned participation in an interventional clinical trial.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (30)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ospedale Generale Regionale " F.Miulli " Coordinator of this site? Confirm its status | Acquaviva delle Fonti | Italy | Recruiting |
| Azienda Ospedaliero-Universitaria delle Marche Coordinator of this site? Confirm its status | Ancona | Italy | Recruiting |
| A.O.U. Consorziale Policlinico Coordinator of this site? Confirm its status | Bari | Italy | Recruiting |
| Asst Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Recruiting |
| Ospedale Bellaria Coordinator of this site? Confirm its status | Bologna | Italy | Recruiting |
| A.O.U. Renato Dulbecco Coordinator of this site? Confirm its status | Catanzaro | Italy | Recruiting |
| A.O.U Careggi Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| IRCCS Ospedale Policlinico San Martino Coordinator of this site? Confirm its status | Genova | Italy | Recruiting |
| A.O.U. Policlinico G. Martino Coordinator of this site? Confirm its status | Messina | Italy | Recruiting |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST GOM Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| IRCCS Cà Granda Ospedale Maggiore Policlinico Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| A.O.U. Policlinico Universitario Coordinator of this site? Confirm its status | Monserrato | Italy | Recruiting |
| AORN A. Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| A.O.U. Università della Campania L. Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Recruiting |
| A.O.U. San Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Recruiting |
| Azienda Ospedale Universita Padova Coordinator of this site? Confirm its status | Padova | Italy | Recruiting |
| IRCCS Fondazione Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Recruiting |
| Azienda Ospedaliera Perugia Coordinator of this site? Confirm its status | Perugia | Italy | Recruiting |
| A.O.U. Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Recruiting |
| Ospedale degli Infermi Coordinator of this site? Confirm its status | Rimini | Italy | Recruiting |
| Ospedale Sant'Andrea Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione PTV - POLICLINICO TOR VERGATA Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
| A.O.U. San Giovanni di Dio e Ruggì D'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
| IRCCS Fondazione Casa Sollievo della Sofferenza Coordinator of this site? Confirm its status | San Giovanni Rotondo | Italy | Recruiting |
| A.O.U. Sassari Coordinator of this site? Confirm its status | Sassari | Italy | Recruiting |
| Ospedale Ca' Foncello Coordinator of this site? Confirm its status | Treviso | Italy | Recruiting |
| AOUI Verona - Policlinico "G.B. Rossi" Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.