Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Other

If ‘other’, further details on the scope of the study

Post-Authorization Safety Study (PASS)

Data collection methods

Combined primary and secondary data collection
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

Vyvgart

Study drug International non-proprietary name (INN) or common name

EFGARTIGIMOD ALFA

Medical condition to be studied

Myasthenia gravis
Population studied

Age groups

Adult and elderly population (>18 years)
Adults (18 to < 65 years)
Adults (18 to < 46 years)
Adults (46 to < 65 years)
Elderly (≥ 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

680
Study design details

Study design

This is a non-interventional, prospective, post authorisation safety study.

Main study objective

A non-interventional 10-year Post-Authorization Safety Study (PASS) in a post-marketing setting comparing cohorts of patients with gMG treated with efgartigimod to those treated with other MG medication, in order to estimate the incidence rates of serious infection and other safety events.

Setting

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 enrol 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 enrol into the non-efgartigimod cohort.

Outcomes

To evaluate the overall long-term safety of efgartigimod including the occurrence of serious infections in gMG patients treated with efgartigimod compared to gMG patients not exposed to efgartigimod.