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Observational study of patients with moderate to severe systemic lupus erythematosus in Russia

An Observational Multicenter Retrospective-prospective Study of Patients With Active Moderate to Severe SLE

Observational AstraZeneca · NCT06759519

This study is trying to gather information about patients with moderate to severe lupus in Russia to better understand their experiences and treatment options.

Quick facts

Study typeObservational
Enrollment600 (estimated)
SexAll
SponsorAstraZeneca Industry-sponsored
Locations29 sites (Belgorod and 28 other locations)
Trial IDNCT06759519 on ClinicalTrials.gov

What this trial studies

This multicenter observational study aims to gather clinical and demographic data on patients with moderate to severe systemic lupus erythematosus (SLE) in Russia. It consists of both retrospective and prospective phases, with approximately 1000 patients expected to be enrolled in the retrospective phase and around 600 in the prospective phase. The study will take place across 50 sites in the Russian Federation, focusing on understanding the epidemiology, clinical outcomes, and treatment patterns of SLE in the population. The data collected will help fill the gaps in knowledge regarding SLE in Russia, where systematic monitoring is currently lacking.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of systemic lupus erythematosus and recent clinical data.

Not a fit: Patients who have been regularly using biologic drugs for SLE treatment or who are currently participating in interventional trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the epidemiology and treatment outcomes of systemic lupus erythematosus, leading to improved patient care and management strategies.

How similar studies have performed: While this study addresses a significant gap in data for SLE in Russia, similar observational studies in other regions have shown success in improving understanding and management of autoimmune diseases.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Belgorod and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Lupus ErythematosusSystemic lupus erythematosusSLE
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.