Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia

Korábbi kezelés

• Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion;
• Current use of genetically engineered biological drugs for SLE treatment;

Más betegség

• 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.

Egyéb

• Participation in any interventional trial since the last patient's visit to the clinic;
• Presence of lupus nephritis class III/IV ± V at the moment of the last patient's visit to the clinic;
• Presence of neuropsychiatric lupus at the moment of the last patient's visit to the clinic.
  • Additional exclusion criteria for the prospective phase are:
• Current participation in any interventional trial;
• Presence of lupus nephritis Class III/IV ± V at the moment of patient's visit;
• Presence of neuropsychiatric lupus at the moment of patient's visit;

• Patients with the diagnosis of SLE (ICD code: M32) confirmed by medical records;
• 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;
• Age ≥ 18 years at the time of last patient's visit to the clinic.
  • Additional inclusion criteria for the prospective phase are:
• Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the prospective phase of the study;
• Disease activity measured with SLEDAI-2K ≥ 6 despite of standard treatment at the time of inclusion in the prospective phase of the study