Actively Recruiting
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Led by argenx · Updated on 2026-02-17
680
Participants Needed
35
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe the long-term safety of efgartigimod treatment in adults with generalized myasthenia gravis gMG. It compares patients who are starting or have recently started efgartigimod treatment with those who have not been exposed to efgartigimod and are receiving other standard treatments. The study is non-interventional and prospective, focusing on real-world safety outcomes over an extended period. Participants are divided into two groups one receiving efgartigimod and another receiving other medications for myasthenia gravis. This study does not involve any new treatments being administered as part of the trial but monitors patients during their routine care. The study will continue for up to 10 years to gather long-term safety data. During the study, researchers will track the occurrence of serious infections and other safety concerns in both groups. Patients will be monitored through their regular clinical visits without additional interventions from the study. Participants may be followed for up to 10 years to assess safety outcomes associated with their treatments in everyday medical practice.
CONDITIONS
Brief Title
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with generalized myasthenia gravis who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment
- Patients diagnosed with generalized myasthenia gravis who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment
- Have provided appropriate written informed consent
You will not qualify if you...
- None
Research Team
S
Sabine Coppieters, MD
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