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

Launched by ASTRAZENECA · Dec 29, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on understanding the characteristics of patients with moderate to severe active systemic lupus erythematosus (SLE), a complex autoimmune disease where the body's immune system mistakenly attacks its own tissues. Researchers will collect information about patients' medical history and current health through two visits: one to review past medical records and another to assess current health. The study will take place in about 50 locations across Russia and aims to include around 1,000 patients for the initial review, with about 600 of those also participating in the follow-up assessment.

To be eligible for the study, participants must be at least 18 years old and have a confirmed diagnosis of SLE. They should have had at least one clinic visit in the past two years. Important to note, those who have recently used certain advanced medications for SLE or have specific severe complications related to the disease, like serious kidney issues or neuropsychiatric symptoms, may not qualify. Participants can expect to share their health information and experience, helping researchers better understand SLE and potentially improve treatments in the future.

Gender

ALL

Eligibility criteria

• 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.