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NCT05141201 Clinical Trial

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

Lupus Erythematosus, Systemic Clinical Trial

Official title:
Saphnelo for Intravenous Infusion 300 mg Specific Use Result Study All Patient Investigation in Patients With Systemic Lupus Erythematosus

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05141201
Other study ID # D3461C00022
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date December 21, 2021
Est. completion date November 30, 2025

Study information
Verified date May 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1620
Est. completion date November 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: patients with systemic lupus erythematosus insufficiently responding to currently available treatment - Exclusion Criteria: None -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Aomori
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukui
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Ishikawa
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kagoshima
Japan Research Site Kanagawa
Japan Research Site Kochi
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Miyazaki
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Nara
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Saga
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Shimane
Japan Research Site Shizuoka
Japan Research Site Tochigi
Japan Research Site Tokushima
Japan Research Site Tokyo
Japan Research Site Tottori
Japan Research Site Toyama
Japan Research Site Wakayama
Japan Research Site Yamagata
Japan Research Site Yamaguchi
Japan Research Site Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ADRs Incidence of ADRs related to Anifrolimab. Safety specification: Herpes zoster, serious infections, anaphylaxis, malignancy and reactivation of hepatitis B virus from the baseline to 52 weeks
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