SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)

AstraZeneca

Status: Active, not recruiting

Conditions: Lupus Erythematosus, Systemic

Study type: Observational

Funder types: Industry

Identifiers

NCT05141201

D3461C00022

Details and patient eligibility

About

To collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus in the real-world post-marketing setting.

Full description

The objective of the Specific Use Result Study is to collect information on and evaluate the long-term safety and effectiveness of Anifrolumab in patients with systemic lupus erythematosus insufficiently responding to currently available treatment in the real-world post-marketing setting.

This investigation will be conducted to support the application for re-examination specified in Article 14-4 of the Pharmaceutical Affairs Law.

Enrollment: 1,620 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

patients with systemic lupus erythematosus insufficiently responding to currently available treatment -

Exclusion criteria

None