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
1 other identifier
observational
1,620
1 country
47
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2021
Longer than P75 for all trials
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2021
CompletedFirst Posted
Study publicly available on registry
December 2, 2021
CompletedStudy Start
First participant enrolled
December 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2027
March 19, 2026
March 1, 2026
5.3 years
November 19, 2021
March 17, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
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
Eligibility Criteria
patients with systemic lupus erythematosus insufficiently responding to currently available treatment
You may qualify if:
- patients with systemic lupus erythematosus insufficiently responding to currently available treatment -
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (47)
Research Site
Aichi, Japan
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Akita, Japan
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Aomori, Japan
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Chiba, Japan
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Ehime, Japan
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Fukui, Japan
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Fukuoka, Japan
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Fukushima, Japan
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Gifu, Japan
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Gunma, Japan
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Hiroshima, Japan
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Hokkaido, Japan
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Hyōgo, Japan
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Ibaraki, Japan
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Ishikawa, Japan
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Kagawa, Japan
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Kagoshima, Japan
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Kanagawa, Japan
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Kochi, Japan
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Kumamoto, Japan
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Kyoto, Japan
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Mie, Japan
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Miyagi, Japan
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Miyazaki, Japan
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Nagano, Japan
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Nagasaki, Japan
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Nara, Japan
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Niigata, Japan
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Numakunai, Japan
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Okayama, Japan
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Okinawa, Japan
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Osaka, Japan
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Ōita, Japan
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Saga, Japan
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Saitama, Japan
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Shiga, Japan
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Shimane, Japan
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Shizuoka, Japan
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Tochigi, Japan
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Tokushima, Japan
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Tokyo, Japan
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Tottori, Japan
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Toyama, Japan
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Wakayama, Japan
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Yamagata, Japan
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Yamaguchi, Japan
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Yamanashi, Japan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2021
First Posted
December 2, 2021
Study Start
December 21, 2021
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
March 31, 2027
Last Updated
March 19, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level datain an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluatedas per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes,indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.