A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
Launched by ARGENX · Mar 1, 2024
Trial Information
Current as of April 29, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the safety of a medication called efgartigimod alfa in patients with a condition known as generalized Myasthenia Gravis (gMG), which affects muscle strength and can cause weakness. The trial is designed to include two groups of patients: those who are about to start treatment with efgartigimod or are already in their first treatment cycle, and those who have not yet received efgartigimod and do not plan to start it during the trial.
If you are diagnosed with gMG and meet these criteria, you may be eligible to join the study. Participants will be required to provide written consent to take part. The study is currently recruiting patients of all genders, typically aged between 65 and 74. Since this is a non-interventional study, participants will not be given any specific treatment for the trial; instead, it will focus on observing the safety of efgartigimod in real-world use. This means you can expect to share your experiences and any side effects you may encounter while receiving treatment. There are no specific exclusions, so as long as you meet the inclusion criteria, you may have the opportunity to contribute valuable information to help improve the understanding of this medication's safety.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients diagnosed with gMG who are expected to start commercial efgartigimod at enrolment or who are within their first cycle of efgartigimod at enrolment or Patients diagnosed with gMG 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
- Exclusion Criteria:
- • None
About Argenx
Argenx is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative therapies for the treatment of autoimmune diseases and cancer. Leveraging its proprietary antibody engineering platform, the company focuses on harnessing the power of its unique antibody candidates to address unmet medical needs. With a commitment to advancing patient care, argenx collaborates with healthcare professionals and stakeholders to drive clinical research and deliver cutting-edge solutions that enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Louisville, Kentucky, United States
Boca Raton, Florida, United States
Austin, Texas, United States
St. Petersburg, Florida, United States
O'fallon, Illinois, United States
Leuven, , Belgium
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported