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

Recruitingn/aAges 18 Years - anyAllargenx
NCT07595653 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

30 sites
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy
A.O.U. Consorziale Policlinico
Bari, Italy
ASST Papa Giovanni XXIII
Bergamo, Italy
Ospedale Bellaria
Bologna, Italy
A.O.U. Renato Dulbecco
Catanzaro, Italy
A.O.U. Careggi
Florence, Italy
IRCCS Ospedale Policlinico San Martino
Genova, Italy

…and 22 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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