An Observational Multicenter Retrospective-prospective Study of Patients With Active Moderate to Severe SLE
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 637
- 试验地点
- 32
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for the retrospective phase are:
- •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.
- •Additional inclusion criteria for the prospective phase are:
- •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
排除标准
- •Exclusion criteria for the retrospective phase are:
- •Regular use of genetically engineered biological drugs for SLE treatment within the last 24 months prior to inclusion;
- •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.
- •Additional exclusion criteria for the prospective phase are:
- •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.
结局指标
主要结局
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.
时间窗: patient's visit to the doctor (Visit 2 -prospective data collection)
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).
次要结局
- 6. Proportion of patients from each residential region of Russia(inclusion of a patient into retrospective part of the study (Visit 1))
- 7. Mean SLEDAI-2K activity total score at Visit 1 (if available)(inclusion of a patient into retrospective part of the study (Visit 1))
- 8. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 1 (if available):(inclusion of a patient into retrospective part of the study (Visit 1))
- 9. The proportion of patients with each SLE activity category based on SLEDAI-2K total score at Visit 2:(patient's visit to the doctor (prospective part of the study))
- 10. Mean SLICC/ACR damage index score by each domain and total score at Visit 2(patient's visit to the doctor (Visit 2 -prospective data collection))
- 1. Mean age at the inclusion into the study(inclusion into the study)
- 17. Proportion of patient receiving immunosuppressive agents (azathioprine, cyclophosphamide, methotrexate, mycophenolate mofetil, cyclosporine, calcineurin inhibitors etc.) as a single agent or combination(Retrospective and prospective data collection (Visit 1, Visit 2))
- 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))
- 11. The proportion of patients with various organ domain involvement:(Retrospective and prospective data collection (Visit 1, Visit 2))
- 12. The proportion of patients with various comorbidities and concomitant treatment(patient's visit to the doctor (Visit 2 -prospective data collection))
- 13. The proportion of patients with various groups of SLE treatment medications in anamnesis (at Visit 1)(inclusion of a patient into retrospective part of the study (Visit 1))
- 14. The proportion of patients taking various groups and drugs of SLE treatment medications (at Visit 2);(patient's visit to the doctor (Visit 2 -prospective data collection))
- 15. The mean (median) of oral glucocorticosteroids (OGCS) daily dose,(Retrospective and prospective data collection (Visit 1, Visit 2))
- 16. The proportion of patients received OGCS daily dose (prednisolone equivalent) more than 5 mg/day;(Retrospective and prospective data collection (Visit 1, Visit 2))
- 19. The mean value of hematology laboratory parameters(patient's visit to the doctor (Visit 2 -prospective data collection))
- 20. The proportion of patients with leukopenia <4,000/mm³;(patient's visit to the doctor (Visit 2 -prospective data collection))
- 18. The mean value of immunological laboratory parameters(Visit 2 (within around a year from inclusion into the study))
- 21. The proportion of patients with thrombocytopenia <100,000/mm³.(patient's visit to the doctor (Visit 2 -prospective data collection))