Post-Authorisation Safety Study (PASS) to Evaluate the Risk of Malignancies in Patients with Myasthenia Gravis (MG) Treated with Efgartigimod

Study identification

• EU PAS number:
  EUPAS1000000915
• Study ID:
  1000000915
• Official title and acronym:
  Post-Authorisation Safety Study (PASS) to Evaluate the Risk of Malignancies in Patients with Myasthenia Gravis (MG) Treated with Efgartigimod
• DARWIN EU® study:
  No
• Study countries:
  France

  United Kingdom

  United States
• Study description:
  This is a multinational, longitudinal database cohort study which aims to assess the risk of malignancy in patients with MG exposed to at least one dose of efgartigimod compared to MG patients with no record of exposure to efgartigimod by analysing data from three claims databases. The reference cohort will consist of patients with a diagnosis code for MG without efgartigimod exposure but are on any other therapy for the treatment of MG during the study period.; Patients will be followed from study entry to at least 10 years following inclusion in the study.
• Study status:
  Planned

Research institutions and networks

Institutions

argenx BV

Study timelines

Date when funding contract was signed

Actual:08/09/2023

Study start date

Planned:01/09/2026

Data analysis start date

Planned:01/09/2026

Date of final study report

Planned:01/09/2039

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)