A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab (SIMA PASS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/106836
• EU PAS number:
  EUPAS105690
• Study ID:
  106836
• Official title and acronym:
  A Non-Interventional Multi-Country Post-Authorisation Safety Study (PASS) to Assess the Incidence of Serious Infections & Malignancies in Systemic Lupus Erythematosus (SLE) Patients Exposed to Anifrolumab (SIMA PASS)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  Spain
• Study description:
  This is an observational study, in which the main research question is to evaluate the risk of malignancies and serious infections among moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care (SOC) who do not initiate anifrolumab.
• Study status:
  Planned

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 29/03/2022

Actual: 29/03/2022

Study start date

Planned: 31/05/2025

Data analysis start date

Planned: 01/08/2025

Date of interim report, if expected

Planned: 31/05/2027

Date of final study report

Planned: 30/11/2032

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AstraZeneca

Study protocol

Initial protocol

AZ Saphnelo PASS study protocol v3.0_Redacted

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)