Impact of efgartigimod on overall disease experience in adults with generalized myasthenia gravis in Italy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study collects real-world data from Italian patients with AChR-antibody positive generalized MG who are treated with efgartigimod as part of standard care. Data are gathered at baseline, 6 months, and 12 months, with additional medical chart information covering MG history, therapies, exacerbations, hospitalizations, and prior MG events in the year before baseline. The primary aim is to describe clinical outcomes and patient-reported experiences in routine practice over up to 23 months. No interventional procedures are mandated by the study, and treatment decisions are made independently of participation. Results will provide real-world evidence on how efgartigimod impacts disease burden and patient quality of life in Italy.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ADAPT Forward master protocol testing multiple regimens for generalized myasthenia gravis

  This platform tests several drug regimens, including efgartigimod IV and empasiprubart IV, in adults with generalized myasthenia gravis to find safer and more effective treatment combinations.

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• Adding empasiprubart to efgartigimod for AChR-antibody positive generalized myasthenia gravis

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• Empasiprubart IV in people with AChR-Ab positive generalized myasthenia gravis

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• Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults

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• Treatment approaches for AChR-antibody positive generalized myasthenia gravis in Russia.

  This project will look at which treatments adults in Russia with AChR-antibody positive generalized myasthenia gravis receive and how their symptoms and hospitalizations change over time.

  Recruiting at 7 sites AstraZeneca · Kazan' and 6 other locations · NCT07247279

• Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.