A non-interventional, post-authorisation safety study of patients treated with efgartigimod alfa

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/1000000019
• EU PAS number:
  EUPAS1000000019
• Study ID:
  1000000019
• Official title and acronym:
  A non-interventional, post-authorisation safety study of patients treated with efgartigimod alfa
• DARWIN EU® study:
  No
• Study countries:
  European Union

  United States
• Study 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.; Enrolment of patients will be over at least a 5-year period. The follow up of patients will continue for 5 years from the time the last patient has been enrolled. Patients will be followed up regardless of whether they continue or discontinue efgartigimod.
• Study status:
  Ongoing

Research institution and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Study timelines

Date when funding contract was signed

Planned: 31/03/2024

Study start date

Actual: 14/12/2023

Date of final study report

Planned: 01/06/2034

Study protocol

Initial protocol

ARGX-113-PASS-2208-Protocol_Redacted.pdf

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)