Clinical trial

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

Name

ARGX-113-PASS-2208

Description

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.

Trial arms

Trial start

2024-06-01

Estimated PCD

2034-06-01

Trial end

2034-06-01

Status

Not yet recruiting

Treatment

efgartigimod

Arms:

efgartigimod cohort

Size

680

Primary endpoint

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

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 680, 'type': 'ESTIMATED'}}

Updated at

2024-03-07

1 organization

1 product

1 indication

Organization

Argenx

Product

efgartigimod

Indication

Myasthenia Gravis