Clinical Trials in Germany / NCT07000110
Recruiting
Observational
Anifrolumab Malignancy and Serious Infections Study
NCT07000110 · tracked via the Priya Life Science Germany tracker
Condition(s) studied
Systemic Lupus Erythematosus
Investigational drug(s) / intervention(s)
Anifrolumab: Anifrolumab prescribed per local practice
Study summary
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.
Eligibility
Inclusion Criteria:
* First prescription of anifrolumab in the study period (no anifrolumab prescription prior to index date): date of first anifrolumab prescription will be the index date
* A minimum data availability of 12 months prior to index date
* Age ≥18 years at index date
* SLE severity: patients with moderate to severe SLE at index date
* SLE activity: patients with at least a flare (uncontrolled SLE) in the 6 months prior to index date
Exclusion Criteria:
* A diagnosis of any malignancy prior to index date
* A diagnosis of HIV/AIDS or congenital immunodeficiency prior to index date
* Organ or bone marrow transplant procedure prior to index date
* A diagnosis of serious infection in the previous 6 months
Primary outcome measure(s)
- Malignancies — Indexdate to November 2031
Defined as the first coded diagnosis for hematological malignancies and solid tumors available in the data source - Serious infection — Indexdate to November 2027
Infection leading to hospitalization, use of intravenous antimicrobials or an infection-related death - Infections leading to hospitalisation — Index date to November 2027
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 - Infection-related death — Indexdate to November 2027
Recorded diagnosis of infection in primary or secondary care settings with record of death within the subsequent month
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Research Site | Copenhagen | Denmark | Recruiting |
| Research Site | Charenton-le-Pont | France | Recruiting |
| Research Site | Essen | Germany | Recruiting |
| Research Site | Barcelona | Spain | Recruiting |
On this site
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A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
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Other trials for the same condition
A First-in-Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7507062 in Participants With Systemic Lupus Erythematosus
Active, not recruiting
Study of Subcutaneous (SC) Belimumab in Pediatric Participants With Systemic Lupus Erythematosus (SLE)
Active, not recruiting
Phase 3 Study to Evaluate Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 2)
Active, not recruiting
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07000110 on ClinicalTrials.gov ↗ ← All trials in Germany