Real-life longitudinal observational data collection to evaluate the efficacy and safety of the type I interferon receptor antagonist anifrolumab in patients with systemic lupus erythematosus

Real-life longitudinal observational data collection to evaluate the efficacy and safety of the type I interferon receptor antagonist anifrolumab in patients with systemic lupus erythematosus - SLANI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00034580

Enrollment

Registered

2024-07-04

Start date

2023-09-20

Completion date

Unknown

Last updated

2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M32

Interventions

Group 1: Up to 50 consecutive patients with systemic lupus erythematosus. All examinations are performed as part of the clinical routine. Data are collected only if available. Baseline: -Clinical par

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Subject must be able to understand and communicate with the investigator and comply with the requirements of the study, must give a written and signed and dated informed consent before any study assessment is performed 2. Written informed consent 3. Age = 18 4. Diagnosis of SLE according to ACR/EULAR 2019 classification criteria. 5. Ongoing treatment with Anifrolumab as part of the clinical routine

Exclusion criteria

Exclusion criteria: 1. Incapability of giving informed consent to study participation 2. Off-label treatment with Anifrolumab

Design outcomes

Primary

Measure	Time frame
1. SLEDAI (SLE Disease Activity Index) 2. Adverse Events	—

Secondary

Measure	Time frame
1. TJC/SJC (Tender and swollen joint count) 2. CLASI (Cutaneous Lupus Activity Score Index) 3. VAS Pain (Patient), VAS Disease activity (Patient, Physician) 4. Patient Reported Outcomes (PROs): HAQ, Facit Fatigue 5. LLDAS (Lupus Low Disease Activity State) 6. Anti-dsDNA (anti-double stranded DNA antibodies), ANAs (Anti-nuclear antibodies) C3, C4, CRP, Serum IgG levels 7. Drug Survival: This endpoint measures the time a patient remains on a particular therapy before discontinuing due to adverse events or treatment failure. Drug Survival can serve as an indicator of treatment tolerability and efficacy.	—

Measure

Time frame

1. TJC/SJC (Tender and swollen joint count) 2. CLASI (Cutaneous Lupus Activity Score Index) 3. VAS Pain (Patient), VAS Disease activity (Patient, Physician) 4. Patient Reported Outcomes (PROs): HAQ, Facit Fatigue 5. LLDAS (Lupus Low Disease Activity State) 6. Anti-dsDNA (anti-double stranded DNA antibodies), ANAs (Anti-nuclear antibodies) C3, C4, CRP, Serum IgG levels 7. Drug Survival: This endpoint measures the time a patient remains on a particular therapy before discontinuing due to adverse events or treatment failure. Drug Survival can serve as an indicator of treatment tolerability and efficacy.

—

Countries

Germany

Contacts

Public ContactFilippo Fagni

Medizinische Klinik 3- Rheumatologie und Immunologie. Universitätsklinikum Erlangen

filippo.fagni@uk-erlangen.de+4991318547506

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026