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
Recruiting
- Conditions
- M32Systemic lupus erythematosus
- Registration Number
- DRKS00034580
- Lead Sponsor
- Medizinische Klinik 3- Rheumatologie und Immunologie. Universitätsklinikum Erlangen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 50
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
1. Incapability of giving informed consent to study participation
2. Off-label treatment with Anifrolumab
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. SLEDAI (SLE Disease Activity Index) <br>2. Adverse Events
- Secondary Outcome Measures
Name Time Method 1. TJC/SJC (Tender and swollen joint count) <br>2. CLASI (Cutaneous Lupus Activity Score Index) <br>3. VAS Pain (Patient), VAS Disease activity (Patient, Physician) <br>4. Patient Reported Outcomes (PROs): HAQ, Facit Fatigue <br>5. LLDAS (Lupus Low Disease Activity State) <br>6. Anti-dsDNA (anti-double stranded DNA antibodies), ANAs (Anti-nuclear <br>antibodies) C3, C4, CRP, Serum IgG levels <br>7. Drug Survival: This endpoint measures the time a patient remains on a <br>particular therapy before discontinuing due to adverse events or treatment <br>failure. Drug Survival can serve as an indicator of treatment tolerability and <br>efficacy.