Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06298565

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

Status
Recruiting
Phase
Study type
Observational
Enrollment
680 (estimated)
Sponsor
argenx · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BIOLOGICALefgartigimodefgartigimod

Timeline

Start date
2024-11-04
Primary completion
2034-06-01
Completion
2034-06-01
First posted
2024-03-07
Last updated
2026-02-17

Locations

35 sites across 6 countries: United States, Austria, Belgium, Germany, Italy, Spain

Regulatory

Source: ClinicalTrials.gov record NCT06298565. Inclusion in this directory is not an endorsement.