Actively Recruiting
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
Led by argenx · Updated on 2026-05-19
100
Participants Needed
30
Research Sites
34 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adult patients with generalized myasthenia gravis (gMG) who are positive for acetylcholine receptor (AChR) antibodies. The study aims to gather real-world evidence from Italian clinical practice on how efgartigimod alfa affects clinical outcomes and patient-reported experiences in those treated for gMG. This observational study will follow patients over a total duration of up to 23 months. The study involves collecting primary data at a baseline visit and follow-up visits at 6 and 12 months after baseline. Researchers will also gather secondary data from medical charts covering the 12 months before baseline, including details on MG-related therapies, exacerbations, hospitalizations, and the patients' medical history. The treatment with efgartigimod alfa is decided independently by the treating physician as part of routine care, not influenced by study participation. Participants will be monitored through clinical assessments and questionnaires measuring changes in MG-Activities of Daily Living (MG-ADL) scores and the percentage achieving minimal symptom expression (MSE) up to 12 months. Additional measures include quality of life, fatigue, anxiety and depression, sleep quality, and caregiver burden scores tracked over the same period. The study collects comprehensive data to understand disease experience and treatment impact, with safety and outcomes evaluated throughout the 23-month period.
CONDITIONS
Brief Title
A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years old at signing of informed Consent Form (ICF) and privacy form (PF)
- Documented diagnosis of generalized myasthenia gravis (gMG)
- Positive for acetylcholine receptor (AChR) antibodies
- Treating physician has decided to initiate efgartigimod alfa as part of routine clinical care independently of the study
You will not qualify if you...
- Hypersensitivity to efgartigimod alfa or any listed excipients including 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants provide primary data and their medical history is documented, including information on myasthenia gravis-related therapies and hospitalizations from the past 12 months.
1 baseline visit (in-person)
Duration - 12 months
Participants are observed over time with follow-up assessments to evaluate changes in disease experience and related measures.
2 follow-up visits at month 6 and month 12 (in-person)
Trial Site Locations
Total: 30 locations
1
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, Italy, 70021
Actively Recruiting
2
Azienda Ospedaliero Universitaria delle Marche
Ancona, Italy, 60126
Actively Recruiting
3
A.O.U. Consorziale Policlinico
Bari, Italy, 70124
Actively Recruiting
4
ASST Papa Giovanni XXIII
Bergamo, Italy, 24127
Actively Recruiting
5
Ospedale Bellaria
Bologna, Italy, 40139
Actively Recruiting
6
A.O.U. Renato Dulbecco
Catanzaro, Italy, 88100
Actively Recruiting
7
A.O.U. Careggi
Florence, Italy, 50134
Actively Recruiting
8
IRCCS Ospedale Policlinico San Martino
Genova, Italy, 16132
Actively Recruiting
9
A.O.U. Policlinico G. Martino
Messina, Italy, 98124
Actively Recruiting
10
IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122
Actively Recruiting
11
Ospedale San Raffaele
Milan, Italy, 20132
Actively Recruiting
12
IRCCS Istituto Neurologico Carlo Besta
Milan, Italy, 20133
Actively Recruiting
13
ASST GOM Niguarda
Milan, Italy, 20162
Actively Recruiting
14
A.O.U. Policlinico Universitario
Monserrato, Italy, 09042
Actively Recruiting
15
AORN A. Cardarelli
Naples, Italy, 80131
Actively Recruiting
16
A.O.U. Università della Campania L. Vanvitelli
Naples, Italy, 80138
Actively Recruiting
17
A.O.U. San Luigi Gonzaga
Orbassano, Italy, 10043
Actively Recruiting
18
Azienda Ospedale Università Padova
Padova, Italy, 35128
Actively Recruiting
19
IRCCS Fondazione Mondino
Pavia, Italy, 27100
Actively Recruiting
20
Azienda Ospedaliera Perugia
Perugia, Italy, 06132
Actively Recruiting
21
A.O.U. Pisana
Pisa, Italy, 56124
Actively Recruiting
22
Ospedale degli Infermi
Rimini, Italy, 47923
Actively Recruiting
23
Fondazione PTV Policlinico Tor Vergata
Roma, Italy, 00133
Actively Recruiting
24
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
25
Ospedale Sant'Andrea
Roma, Italy, 00189
Actively Recruiting
26
A.O.U. San Giovanni di Dio e Ruggi D'Aragona
Salerno, Italy, 84131
Actively Recruiting
27
IRCCS Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy, 71013
Actively Recruiting
28
A.O.U. Sassari
Sassari, Italy, 07100
Actively Recruiting
29
Ospedale Ca' Foncello
Treviso, Italy, 31100
Actively Recruiting
30
AOUI Verona - Policlinico G.B. Rossi
Verona, Italy, 37134
Actively Recruiting
Research Team
S
Sabine Coppieters, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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