Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07000110

Anifrolumab Malignancy and Serious Infections Study

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 who do not initiate anifrolumab.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Copenhagen, Denmark

Loading trial locations.

About this study

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 who do not initiate anifrolumab.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date
  • A minimum data availability of 12 months prior to index date
  • Age ≥18 years at index date
  • SLE severity: patients with moderate to severe SLE at index date
  • SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date

Exclusion criteria

  • A diagnosis of any malignancy prior to index date
  • A diagnosis of HIV/AIDS or congenital immunodeficiency prior to index date
  • Organ or bone marrow transplant procedure prior to index date
  • A diagnosis of serious infection in the previous 6 months

Treatment and study plan

Anifrolumab

Drug

Anifrolumab prescribed per local practice

Other names: Saphnelo

Primary outcomes

  1. Malignancies

    Time frame: Indexdate to November 2031

    Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source

  2. Serious infection

    Time frame: Indexdate to November 2027

    Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death

  3. Infections leading to hospitalisation

    Time frame: Index date to November 2027

    Infection diagnosis as a part of a hospitalization episode, use of IV antimicrobials, or death, or infection diagnosis in primary or secondary care settings up to 7 days before hospitalization

  4. Infection-related death

    Time frame: Indexdate to November 2027

    Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month

Secondary outcomes

  1. Specific types of malignancies

    Time frame: Indexdate to November 2031

    Haematologic, solid and skin malignancies

  2. Serious infection components

    Time frame: Indexdate to November 2027

    Infection leading to hospitalization, infection requiring treatment with IV antimicrobials and infection-related death

  3. Serious infection types grouped as opportunistic serious infections, other serious infections, pneumonia (overall), fatal and non-fatal pneumonia (separately)

    Time frame: Indexdate to November 2027

Study contacts

Contact information is provided by the study sponsor or research team.

AstraZeneca Clinical Study Information Center

CONTACT

[email protected]

1-877-240-9479

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • IQVIA Pty Ltd

Registry information

Official study title

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

Acronym: SIMA

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jun 2, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.