A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

Recruiting

• Conditions: Myasthenia Gravis
• Interventions: Biological: efgartigimod

• Registration Number: NCT06298565
• Lead Sponsor: argenx

Brief Summary

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-01
• Study First Posted: 2024-03-07
• Study Start: 2024-11-04
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-01
• Primary Completion: 2034-06
• Study Completion: 2034-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 680

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
efgartigimod cohort	efgartigimod	patients treated with efgartigimod

Primary Outcome Measures

Name	Time	Method
The overall long-term safety of efgartigimod including the occurrence of serious infections in generalized myasthenia gravis (gMG) patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod	up to 10 years

Trial Locations

Locations (6)

Norton Neuroscience Institute; 🇺🇸 Louisville, Kentucky, United States

National Neuromuscular Research Institute; 🇺🇸 Austin, Texas, United States

UZ Leuven (University Hospitals Leuven); 🇧🇪 Leuven, Belgium

SFM Clinical Research, LLC; 🇺🇸 Boca Raton, Florida, United States

BayCare Health System, Inc. St Anthony's Hospital; 🇺🇸 St. Petersburg, Florida, United States

Prairie Education and Research Cooperative and HSHS Medical Group; 🇺🇸 O'Fallon, Illinois, United States