A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
POEMA
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
1 other identifier
observational
100
1 country
30
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2026
Typical duration for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 25, 2026
CompletedFirst Submitted
Initial submission to the registry
March 9, 2026
CompletedFirst Posted
Study publicly available on registry
May 19, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2028
May 19, 2026
May 1, 2026
1.7 years
March 9, 2026
May 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Changes in MG-ADL scores from baseline
The Myasthenia Gravis Activities of Living (MG-ADL) scale is an 8-item patient-reported scale that measures MG symptoms and functional status across 4 domains. The total score ranges from 0 to 24, with higher scores indicating greater disability.
Up to 12 months
Percentage of patients achieving MSE
Minimal Symptom Expression (MSE) is defined as an MG-ADL score ≤ 1
Up to 12 months
Secondary Outcomes (10)
Changes in QMG scores over time
Up to 12 months
Changes in MG-QoL-15r scores over time
Up to 12 months
Changes in PROMIS Fatigue SF 4a scores over time
Up to 12 months
Changes in FSS over time
Up to 12 months
Changes in HADS-Anxiety scores over time
Up to 12 months
- +5 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- argenxlead
Study Sites (30)
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021, Italy
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126, Italy
A.O.U. Consorziale Policlinico
Bari, 70124, Italy
ASST Papa Giovanni XXIII
Bergamo, 24127, Italy
Ospedale Bellaria
Bologna, 40139, Italy
A.O.U. Renato Dulbecco
Catanzaro, 88100, Italy
A.O.U. Careggi
Florence, 50134, Italy
IRCCS Ospedale Policlinico San Martino
Genova, 16132, Italy
A.O.U. Policlinico G. Martino
Messina, 98124, Italy
IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Ospedale San Raffaele
Milan, 20132, Italy
IRCCS Istituto Neurologico Carlo Besta
Milan, 20133, Italy
ASST GOM Niguarda
Milan, 20162, Italy
A.O.U. Policlinico Universitario
Monserrato, 09042, Italy
AORN A. Cardarelli
Naples, 80131, Italy
A.O.U. Università della Campania L. Vanvitelli
Naples, 80138, Italy
A.O.U. San Luigi Gonzaga
Orbassano, 10043, Italy
Azienda Ospedale Università Padova
Padova, 35128, Italy
IRCCS Fondazione Mondino
Pavia, 27100, Italy
Azienda Ospedaliera Perugia
Perugia, 06132, Italy
A.O.U. Pisana
Pisa, 56124, Italy
Ospedale degli Infermi
Rimini, 47923, Italy
Fondazione PTV Policlinico Tor Vergata
Roma, 00133, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
Ospedale Sant'Andrea
Roma, 00189, Italy
A.O.U. San Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131, Italy
IRCCS Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013, Italy
A.O.U. Sassari
Sassari, 07100, Italy
Ospedale Ca' Foncello
Treviso, 31100, Italy
AOUI Verona - Policlinico G.B. Rossi
Verona, 37134, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 9, 2026
First Posted
May 19, 2026
Study Start
February 25, 2026
Primary Completion (Estimated)
November 1, 2027
Study Completion (Estimated)
July 1, 2028
Last Updated
May 19, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share