Generalized Myasthenia Gravis (gMG)POEMANCT07595653
A Study to Evaluate the Impact of Efgartigimod on Overall Disease Experience of People Suffering From Generalized Myasthenia Gravis (gMG) in Italy
An observational study of Generalized Myasthenia Gravis (gMG) and gMG, run by argenx at 30 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Myasthenia Gravis (gMG), gMG
- How many people
- 100 participants
- Where
- 30 sitesItaly
- Study dates
- 25 Feb 2026to Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
Italy30 sites, 30 recruiting
- Recruiting
Ospedale Generale Regionale F. Miulli
Acquaviva delle Fonti, 70021
Antonella Petruzzellis, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Francesca Lupidi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Consorziale Policlinico
Bari, 70124
Giammarco Milella, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
ASST Papa Giovanni XXIII
Bergamo, 24127
Manlio Sgarzi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Ospedale Bellaria
Bologna, 40139
Maria Pia Giannoccaro, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Renato Dulbecco
Catanzaro, 88100
Michele Trimboli, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Careggi
Florence, 50134
Valentina Damato, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova, 16132
Marina Grandis, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Policlinico G. Martino
Messina, 98124
Carmelo Rodolico, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122
Daniele Velardo, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Ospedale San Raffaele
Milan, 20132
Yuri Falzone, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
IRCCS Istituto Neurologico Carlo Besta
Milan, 20133
Carlo Antozzi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
ASST GOM Niguarda
Milan, 20162
Francesca Lanzani, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Policlinico Universitario
Monserrato, 09042
Francesca Pili, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
AORN A. Cardarelli
Naples, 80131
Francesco Habetswallner, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Università della Campania L. Vanvitelli
Naples, 80138
Alvino Bisecco, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. San Luigi Gonzaga
Orbassano, 10043
Marinella Clerico, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Azienda Ospedale Università Padova
Padova, 35128
Elena Pegoraro, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
IRCCS Fondazione Mondino
Pavia, 27100
Matteo Gastaldi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Azienda Ospedaliera Perugia
Perugia, 06132
Andrea Mancini, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Pisana
Pisa, 56124
Michelangelo Maestri Tassoni, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Ospedale degli Infermi
Rimini, 47923
Claudio Callegarini, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Fondazione PTV Policlinico Tor Vergata
Roma, 00133
Roberto Massa, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Raffaele Iorio, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Ospedale Sant'Andrea
Roma, 00189
Laura Fionda, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. San Giovanni di Dio e Ruggi D'Aragona
Salerno, 84131
Claudia Vinciguerra, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
IRCCS Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Paolo Emilio Alboini, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
A.O.U. Sassari
Sassari, 07100
Elia Sechi, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
Ospedale Ca' Foncello
Treviso, 31100
Domenico Marco Bonifati, MD, 857-350-4834, clinicaltrials@argenx.com
- Recruiting
AOUI Verona - Policlinico G.B. Rossi
Verona, 37134
Gaetano Nicola Vattemi, MD, 857-350-4834, clinicaltrials@argenx.com
About this study
Official title: 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
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
Read the detailed description
Primary data collection will be performed during the baseline visit and follow-up will be at month 6 and 12 after baseline.
Secondary data collection from medical charts, information on myasthenia gravis (MG) related therapies (including rescue therapies), MG exacerbations, and MG-related hospitalizations will be collected for the 12 months preceding baseline. Additionally, the patient's MG history and overall medical history will be documented.
- Conditions
- Generalized Myasthenia Gravis (gMG), gMG
- Medical subject headings
- Myasthenia Gravis
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Percentage of patients achieving MSE
Minimal Symptom Expression (MSE) is defined as an MG-ADL score ≤ 1
Measured: Up to 12 months
Secondary outcomes (10)
Changes in QMG scores over time
The quantitative myasthenia gravis (QMG) score is a commonly used scale for evaluating muscle weakness associated with myasthenia gravis. It consists in a 13-item direct physician assessment scoring system that quantifies disease severity, based on impairments of body functions and structures. The total QMG score ranges from 0 to 39, where higher scores indicated greater disease severity.
Measured: Up to 12 months
Changes in MG-QoL-15r scores over time
Measured: Up to 12 months
Changes in PROMIS Fatigue SF 4a scores over time
The PROMIS Fatigue Short Form 4a is a four-item questionnaire used to assess the experience of fatigue over the past seven days. The items are designed to capture different aspects of fatigue, including the impact of fatigue on physical and mental activities. The raw score can range from 4 to 20, with higher scores indicating more severe fatigue.
Measured: Up to 12 months
Changes in FSS over time
The Fatigue Severity Scale (FSS) is a self-administered questionnaire with 9 items (questions) investigating the severity of fatigue in different situations during the past week. The final score ranges from 1 to 7.
Measured: Up to 12 months
Changes in HADS-Anxiety scores over time
The Hospital Anxiety and Depression Scale (HADS) is a widely used screening tool that helps to identify possible or probable instances of anxiety and depression among patients in non-psychiatric hospital settings. It consists of 14 items, with 7 items related to anxiety (HADS-A) and 7 related to depression (HADS-D), collecting how the patient was feeling in the previous week. The score for each subscale ranges from 0 to 21.
Measured: Up to 12 months
Changes in HADS-Depression scores over time
The Hospital Anxiety and Depression Scale (HADS) is a widely used screening tool that helps to identify possible or probable instances of anxiety and depression among patients in non-psychiatric hospital settings. It consists of 14 items, with 7 items related to anxiety (HADS-A) and 7 related to depression (HADS-D), collecting how the patient was feeling in the previous week. The score for each subscale ranges from 0 to 21.
Measured: Up to 12 months
Changes in PSQI scores over time
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Up to 12 months
TANDEM - patient version scores over time
The Treatment Assessment in Dual Evaluation Model (TANDEM) - patient version is a non-validated, exploratory PRO designed to assess patient satisfaction with efgartigimod alfa treatment and symptom control in MG. It includes 8 items on therapeutic alignment, treatment experience, and symptom management.
Measured: Up to 12 months
TANDEM - clinician version scores over time
The Treatment Assessment in Dual Evaluation Model (TANDEM) - clinician version is a non-validated, exploratory PRO designed to assess clinician satisfaction with the management of efgartigimod alfa treatment and symptom control in patients with MG. It includes 8 items on therapeutic personalization, treatment effectiveness, and symptom stability.
Measured: Up to 12 months
CBI scores over time
The Caregiver Burden Inventory (CBI) is a 24-item questionnaire designed to assess the following different aspects of caregiver burden. Scores range from 0 to 96, with higher scores indicating greater feelings of burden.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start25 Feb 2026
- Primary completionNov 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia Gravis (gMG)Studies of the same condition, open and under way.
- More trials run by argenxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- argenx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595653
- Sponsor's protocol ID
- ARGX-113-NIS-2411-ITA
- Acronym
- POEMA
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07595653
- Acronym / sponsor ID
- POEMA / ARGX-113-NIS-2411-ITA
- Conditions
- Generalized Myasthenia Gravis (gMG), gMG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- argenxIndustry (pharma, biotech, devices)
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Primary data collection will be performed during the baseline visit and follow-up will be at month 6 and 12 after baseline.
Secondary data collection from medical charts, information on myasthenia gravis (MG) related therapies (including rescue therapies), MG exacerbations, and MG-related hospitalizations will be collected for the 12 months preceding baseline. Additionally, the patient's MG history and overall medical history will be documented.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changes in MG-ADL scores from baseline
Time frame: Up to 12 months
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.
Percentage of patients achieving MSE
Time frame: Up to 12 months
Minimal Symptom Expression (MSE) is defined as an MG-ADL score ≤ 1
10 secondary outcomes
Changes in QMG scores over time
Time frame: Up to 12 months
Changes in MG-QoL-15r scores over time
Time frame: Up to 12 months
Changes in PROMIS Fatigue SF 4a scores over time
Time frame: Up to 12 months
Changes in FSS over time
Time frame: Up to 12 months
Changes in HADS-Anxiety scores over time
Time frame: Up to 12 months
Changes in HADS-Depression scores over time
Time frame: Up to 12 months
Changes in PSQI scores over time
Time frame: Up to 12 months
TANDEM - patient version scores over time
Time frame: Up to 12 months
TANDEM - clinician version scores over time
Time frame: Up to 12 months
CBI scores over time
Time frame: Up to 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Generalized Myasthenia Gravis (gMG) and gMG, run by argenx at 30 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sabine Coppieters, MD (857-350-4834, clinicaltrials@argenx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in MG-ADL scores from baseline (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.