Clinical Research Directory

Inclusion Criteria: Inclusion criteria for the retrospective phase are: 1. Patients with the diagnosis of SLE (ICD code: M32) confirmed by medical records; 2. Patients with availability of data of at least one visit to the clinic in the medical records in the last 24 months prior to inclusion; 3. Age ≥ 18 years at the time of last patient's visit to the clinic. Additional inclusion criteria for the prospective phase are: 4. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the prospective phase of the study; 5. Disease activity measured with SLEDAI-2K ≥ 6 despite of standard treatment at the time of inclusion in the prospective phase of the study Exclusion Criteria: Exclusion criteria for the retrospective phase are: 1. Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion; 2. Participation in any interventional trial since the last patient's visit to the clinic; 3. Presence of lupus nephritis class III/IV ± V at the moment of the last patient's visit to the clinic; 4. Presence of neuropsychiatric lupus at the moment of the last patient's visit to the clinic. Additional exclusion criteria for the prospective phase are: 5. Current use of genetically engineered biological drugs for SLE treatment; 6. Current participation in any interventional trial; 7. Presence of lupus nephritis Class III/IV ± V at the moment of patient's visit; 8. Presence of neuropsychiatric lupus at the moment of patient's visit; 9. An acute or chronic disease that, in the opinion of the investigator, limits the ability of patient to provide data on his/her health or participate in this study or influence the interpretation of the results.