A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
Recruiting
Observational Study
Generalized Myasthenia Gravis (gMG)gMG
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
100 (estimated)
Sponsor
argenx · Industry
Who this trial is looking for
This trial is looking for adults with generalized myasthenia gravis (gMG) who have a specific type of antibodies. Taking part involves starting treatment with efgartigimod as decided by their doctor.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with generalized myasthenia gravis.
I am AChR-antibody positive.
My doctor has decided to start treatment with efgartigimod.
You may not be able to join if
I am allergic to any ingredients in efgartigimod.
I am currently in another clinical trial or plan to join one.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 m…
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
Trial Locations
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Eligibility Criteria
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 label…
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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