Trials / Active Not Recruiting
Active Not RecruitingNCT05141201
SAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS)
Saphnelo for Intravenous Infusion 300 mg Specific Use Result Study All Patient Investigation in Patients With Systemic Lupus Erythematosus
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,620 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2021-12-21
- Primary completion
- 2027-03-31
- Completion
- 2027-03-31
- First posted
- 2021-12-02
- Last updated
- 2026-03-19
Locations
47 sites across 1 country: Japan
Source: ClinicalTrials.gov record NCT05141201. Inclusion in this directory is not an endorsement.