An observational study in Systemic Lupus Erythematosus, sponsored by AstraZeneca. Recruiting at 4 sites in 4 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by AstraZeneca · Observational
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Among 46 studies in Lupus Erythematosus, Systemic by AstraZeneca — 19 open to participants now, 25 under way, 6 of them phase 3. Lupus Erythematosus, Systemic · AstraZeneca.
Among the 46 studies in Lupus Erythematosus, Systemic by AstraZeneca, this one is the 2nd largest by planned enrollment of the 19 observational ones that give a count, is one of 10 that started in 2026, is one of 19 observational ones, reaches primary completion later than 22 of the 24 other live ones, and was the 36th registered.
1,210 studies on the registry are indexed under Lupus Erythematosus, Systemic; 406 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →19 of the 46 studies in Lupus Erythematosus, Systemic by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Australia, Belgium, Chile and 7 more countries
Ages 5–17
AstraZeneca · Sites in United States, Argentina, Australia and 32 more countries
Ages 5–80
AstraZeneca · Sites in China
Ages 18–70
AstraZeneca · Sites in United States
Ages 18–130 · Women only
AstraZeneca · Sites in United States, Canada, France and 6 more countries
Ages 18–70
By country, each count listing its studies:
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 93 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 130 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
46 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 11 · Phase 3 9 · Phase 4 1
First in 2008; this study’s year is marked. 10 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 3,506 is above the median of 150 across 281 observational studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 109 across the 26 interventional studies, 500 across the 19 observational. Of the 20 that completed or were terminated, 11 (55%) have results posted.
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AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
5 of the studies in Lupus Erythematosus, Systemic by AstraZeneca that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05138133Phase 3AstraZenecaPhase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis | 2027-02-23 |
| NCT06530849Gracell Biotechnologies (Shanghai) Co., Ltd.A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus | 2027-02-01 |
| NCT05141201AstraZenecaSAPHNELO Systemic Lupus Erythematosus Japan Post-Marketing Surveillance (PMS) | 2027-03-31 |
| NCT06916806AstraZenecaA Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD5492 in Adult Participants With Systemic Lupus Erythematosus or Idiopathic Inflammatory Myopathies or Rheumatoid Arthritis. | 2027-05-05 |
| NCT06594068AstraZenecaProspective Registry Investigating Maternal, Infant, and Lactation Outcomes in Anifrolumab Users | 2027-08-31 |
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Among the 46 studies in Lupus Erythematosus, Systemic by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Moderate/severe SLE patients who receive anifrolumab compared with a comparable population of moderate/severe SLE patients on standard of care (SOC) who do not initiate anifrolumab.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anifrolumab prescribed per local practice
Also known as: Saphnelo
Malignancies
Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source
Time frame: Indexdate to November 2031
Serious infection
Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death
Time frame: Indexdate to November 2027
Infections leading to hospitalisation
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
Time frame: Index date to November 2027
Infection-related death
Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month
Time frame: Indexdate to November 2027
Specific types of malignancies
Haematologic, solid and skin malignancies
Time frame: Indexdate to November 2031
Serious infection components
Infection leading to hospitalization, infection requiring treatment with IV antimicrobials and infection-related death
Time frame: Indexdate to November 2027
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
Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA 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 anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Nov 2031, 70 months after the start.
How these figures are worked out, and which studies are left out of them.
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