Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Eryth… (NCT06759519) | Clinical Trial Compass
CompletedNot Applicable
Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
Russia637 participantsStarted 2024-08-30
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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
Exclusion criteria
. Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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.
Timeframe: patient's visit to the doctor (Visit 2 -prospective data collection)