A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa
ConditionMyasthenia Gravis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
Sponsorargenx
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients diagnosed with gMG
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
efgartigimod
Biological/Vaccineefgartigimod
Treatment groups
680 Participants
are divided into 2 treatment groupsGroup A: efgartigimod cohort1 intervention
Group B: non-efgartigimod cohort0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
up to 10 years Source ClinicalTrials.gov