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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
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

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ospedale Generale Regionale " F.Miulli "
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Acquaviva delle FontiItalyRecruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyRecruiting
A.O.U. Consorziale Policlinico
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BariItalyRecruiting
Asst Papa Giovanni XXIII
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BergamoItalyRecruiting
Ospedale Bellaria
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BolognaItalyRecruiting
A.O.U. Renato Dulbecco
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CatanzaroItalyRecruiting
A.O.U Careggi
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FlorenceItalyRecruiting
IRCCS Ospedale Policlinico San Martino
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GenovaItalyRecruiting
A.O.U. Policlinico G. Martino
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MessinaItalyRecruiting
Ospedale San Raffaele
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MilanItalyRecruiting
IRCCS Istituto Neurologico Carlo Besta
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MilanItalyRecruiting
ASST GOM Niguarda
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MilanItalyRecruiting
IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyRecruiting
A.O.U. Policlinico Universitario
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MonserratoItalyRecruiting
AORN A. Cardarelli
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NaplesItalyRecruiting
A.O.U. Università della Campania L. Vanvitelli
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NaplesItalyRecruiting
A.O.U. San Luigi Gonzaga
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OrbassanoItalyRecruiting
Azienda Ospedale Universita Padova
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PadovaItalyRecruiting
IRCCS Fondazione Mondino
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PaviaItalyRecruiting
Azienda Ospedaliera Perugia
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PerugiaItalyRecruiting
A.O.U. Pisana
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PisaItalyRecruiting
Ospedale degli Infermi
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RiminiItalyRecruiting
Ospedale Sant'Andrea
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RomaItalyRecruiting
Fondazione PTV - POLICLINICO TOR VERGATA
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RomaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomaItalyRecruiting
A.O.U. San Giovanni di Dio e Ruggì D'Aragona
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SalernoItalyRecruiting
IRCCS Fondazione Casa Sollievo della Sofferenza
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San Giovanni RotondoItalyRecruiting
A.O.U. Sassari
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SassariItalyRecruiting
Ospedale Ca' Foncello
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TrevisoItalyRecruiting
AOUI Verona - Policlinico "G.B. Rossi"
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VeronaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.