Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
SEVERUS
An Observational Multicenter Retrospective-prospective Study of Patients With Active Moderate to Severe SLE
1 other identifier
observational
637
1 country
32
Brief Summary
This is a multicenter observational retrospective-prospective study consisting of retrospective and prospective phases. Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. The study will involve approximately 50 sites of the Russian Federation; in each site about 20 patients will be recruited. The total planned size of study population will be approximately 1000 patients enrolled to the retrospective phase of the study, from which \~ 600 patients will be enrolled to the prospective phase.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2024
CompletedStudy Start
First participant enrolled
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 19, 2025
CompletedJuly 9, 2026
June 1, 2026
1.1 years
August 28, 2024
July 8, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
disease activity status at the time of patient visit to the doctor measured with SLEDAI-2K, expressed as the mean SLEDAI-2K total score at Visit 2.
In order to achieve primary objective, the mean SLEDAI-2K total score at Visit 2 will be calculated among patients with moderate to severe SLE (i.e. SLEDAI-2K total score ≥6 measured on the Visit 2) who provided informed consent and were enrolled to the prospective phase. The Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) is a clinical index for the measurement of disease activity in SLE. The modified index SLEDAI-2K was introduced and validated in 2002; it allows the documentation of persistent activity disease in rash, mucous membrane ulcers, alopecia, and proteinuria. 4 activity categories have been defined on the basis of the SLEDAI-2K total score (higher scores indicate more damage): no activity (0 points); low activity (1-4 points); moderate activity (5-10 points), and high activity (\>10 points).
patient's visit to the doctor (Visit 2 -prospective data collection)
Secondary Outcomes (21)
1. Mean age at the inclusion into the study
inclusion into the study
2. Proportion of patients aged 18-44, 45-64, and ≥65 years at the inclusion into the study
inclusion into the study
3. Mean age at the SLE diagnosis
within 24 months prior to inclusion into the study
4. Mean and median SLE duration, years
from the SLE diagnosis to the Visit 1
5. Proportion of men and women
inclusion of a patient into retrospective part of the study (Visit 1)
- +16 more secondary outcomes
Eligibility Criteria
It is planned to enrol \~ 600 patients with moderate to severe SLE. Before that approximately 1000 patients with confirmed diagnosis of SLE will be screened (retrospective phase).
You may qualify if:
- Patients with the diagnosis of SLE (ICD code: M32) confirmed by medical records;
- Age ≥ 18 years at the time of last patient's visit to the clinic.
You may not qualify if:
- 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.
- Current use of genetically engineered biological drugs for SLE treatment;
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Barnaul, Russia
Research Site
Belgorod, Russia
Research Site
Chelyabinsk, Russia
Research Site
Grozny, Russia
Research Site
Irkutsk, Russia
Research Site
Izhevsk, Russia
Research Site
Kaliningrad, Russia
Research Site
Kazan', Russia
Research Site
Kemerovo, Russia
Research Site
Krasnodar, Russia
Research Site
Makhachkala, Russia
Research Site
Moscow, Russia
Research Site
Murmansk, Russia
Research Site
Nizny Novgorod, Russia
Research Site
Novosibirsk, Russia
Research Site
Omsk, Russia
Research Site
Orenburg, Russia
Research Site
Penza, Russia
Research Site
Perm, Russia
Research Site
Petrozavodsk, Russia
Research Site
Ryazan, Russia
Research Site
Saint-Petrburg, Russia
Research Site
Samara, Russia
Research Site
Saransk, Russia
Research Site
Saratov, Russia
Research Site
Surgut, Russia
Research Site
Tula, Russia
Research Site
Ufa, Russia
Research Site
Ulyanovsk, Russia
Research Site
Volgograd, Russia
Research Site
Yaroslavl, Russia
Research Site
Yekaterinburg, Russia
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2024
First Posted
January 6, 2025
Study Start
August 30, 2024
Primary Completion
September 19, 2025
Study Completion
September 19, 2025
Last Updated
July 9, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.