Clinical trial NCT06759519: Clinical and Demographic Features of Patients With Moderate to Severe Active Systemic Lupus Erythematosus in Russia
Official title: An Observational Multicenter Retrospective-prospective Study of Patients With Active Moderate to Severe SLE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
SLE
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2025-01-06
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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).

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.

Detailed description: Systemic lupus erythematosus (SLE) is a systemic autoimmune rheumatic disease with variable clinical manifestations and an unpredictable course, affecting any organs or systems, which quite often develops over several months or years, with persistent or, conversely, rapidly changing clinical manifestations, an undulating course, alternating remissions and flares.

Currently, in Russia there is no exact data on the number of patients with active moderate to severe SLE in the population, since there is no unified system for regular monitoring of patients with SLE in the country. The systematic information about complications and comorbidities, about the treatment approaches and their effectiveness in the Russian population is also absent.

The Russian Federation consists of 85 regions with a total population of more than 145 million people. The regions differ in ethnic composition, age, gender, climate, ecology, economic level, prevalence of SLE in general and moderate to severe SLE in particular.

Thus, there is a need to perform a large-scale observational study in regions of the country with a sufficient size of population to obtain information on moderate to severe SLE epidemiology, clinical and demographic characteristics, to describe main clinical outcomes and evaluate existing associations between observed treatment patterns and clinical outcomes in real clinical practice.

Trial will include 2 visits for obtaining the patient's demographic and clinical data: the 1st is retrospective and the 2nd is prospective. To allow wide data coverage the study will involve approximately 50 sites of Russian Federation; in each site about 20 patients will be recruited.

Overall expected duration of the study (from the first patient inclusion to the last patient last visit) is about 13 months or until 1000 patients will be included in the retrospective phase and \~ 600 patients - in the prospective phase This observational study does not imply any intervention into a routine clinical practice, including choice of treatment modality or special methods of investigation.

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.

Primary outcomes:
measure: 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)
Secondary outcomes:
measure: 1. Mean age at the inclusion into the study
timeFrame: inclusion into the study
measure: 2. Proportion of patients aged 18-44, 45-64, and ≥65 years at the inclusion into the study
timeFrame: inclusion into the study
measure: 3. Mean age at the SLE diagnosis
timeFrame: within 24 months prior to inclusion into the study
measure: 4. Mean and median SLE duration, years
timeFrame: from the SLE diagnosis to the Visit 1
measure: 5. Proportion of men and women
timeFrame: inclusion of a patient into retrospective part of the study (Visit 1)
measure: 6. Proportion of patients from each residential region of Russia
timeFrame: inclusion of a patient into retrospective part of the study (Visit 1)
measure: 7. Mean SLEDAI-2K activity total score at Visit 1 (if available)
timeFrame: inclusion of a patient into retrospective part of the study (Visit 1)
measure: 8. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 1 (if available):
timeFrame: inclusion of a patient into retrospective part of the study (Visit 1)
measure: 9. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 2:
timeFrame: patient's visit to the doctor (prospective part of the study)
measure: 10. Mean SLICC/ACR damage index score by each domain and total score at Visit 2
timeFrame: patient's visit to the doctor (Visit 2 -prospective data collection)
measure: 11. The proportion of patients with various organ domain involvement:
timeFrame: Retrospective and prospective data collection (Visit 1, Visit 2)
measure: 12. The proportion of patients with various comorbidities and concomitant treatment
timeFrame: patient's visit to the doctor (Visit 2 -prospective data collection)
measure: 13. The proportion of patients with various groups of SLE treatment medications in anamnesis (at Visit 1)
timeFrame: inclusion of a patient into retrospective part of the study (Visit 1)
measure: 14. The proportion of patients taking various groups and drugs of SLE treatment medications (at Visit 2);
timeFrame: patient's visit to the doctor (Visit 2 -prospective data collection)
measure: 15. The mean (median) of oral glucocorticosteroids (OGCS) daily dose,
timeFrame: Retrospective and prospective data collection (Visit 1, Visit 2)
measure: 16. The proportion of patients received OGCS daily dose (prednisolone equivalent) more than 5 mg/day;
timeFrame: Retrospective and prospective data collection (Visit 1, Visit 2)
measure: 17. Proportion of patient receiving immunosuppressive agents (azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, cyclosporine, calcineurin inhibitors etc.) as a single agent or combination
timeFrame: Retrospective and prospective data collection (Visit 1, Visit 2)
measure: 18. The mean value of immunological laboratory parameters
timeFrame: Visit 2 (within around a year from inclusion into the study)
measure: 19. The mean value of hematology laboratory parameters
timeFrame: patient's visit to the doctor (Visit 2 -prospective data collection)
measure: 20. The proportion of patients with leukopenia <4,000/mm³;
timeFrame: patient's visit to the doctor (Visit 2 -prospective data collection)
measure: 21. The proportion of patients with thrombocytopenia <100,000/mm³.
timeFrame: patient's visit to the doctor (Visit 2 -prospective data collection)
Other outcomes:
Locations:
city: Belgorod
country: Russian Federation
facility: Research Site
city: Chelyabinsk
country: Russian Federation
facility: Research Site
city: Ekaterinburg
country: Russian Federation
facility: Research Site
city: Grozny
country: Russian Federation
facility: Research Site
city: Irkutsk
country: Russian Federation
facility: Research Site
city: Izhevsk
country: Russian Federation
facility: Research Site
city: Kaliningrad
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Kemerovo
country: Russian Federation
facility: Research Site
city: Krasnodar
country: Russian Federation
facility: Research Site
city: Makhachkala
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Murmansk
country: Russian Federation
facility: Research Site
city: Nizny Novgorod
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: Omsk
country: Russian Federation
facility: Research Site
city: Orenburg
country: Russian Federation
facility: Research Site
city: Penza
country: Russian Federation
facility: Research Site
city: Perm
country: Russian Federation
facility: Research Site
city: Petrozavodsk
country: Russian Federation
facility: Research Site
city: Ryazan
country: Russian Federation
facility: Research Site
city: Saint-Petrburg
country: Russian Federation
facility: Research Site
city: Samara
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Tula
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Ulianovsk
country: Russian Federation
facility: Research Site
city: Volgograd
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
Study officials:
References: