Multicenter, Observational, Descriptive Study of the Diagnosis, Course and Treatment of Patients With SLE in Routine Practice in Kazakhstan: a Registry Study With Retrospective and Prospective Components.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 509
- 试验地点
- 12
- 主要终点
- Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2
研究概览
简要总结
Multicenter, observational, descriptive study of the diagnosis, course and treatment of patients with SLE in routine practice in Kazakhstan: a registry study with retrospective and prospective components.
详细描述
Primary Endpoints
- Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2
- Proportion of patients with PGA changes in dynamics
- Proportion of patients with changes in dynamics in general clinical tests from baseline data (Visit 0) at visits 1 and 2
- Proportion of patients with varying SLE organ damage assessed by SLICC/ACR Damage Index - SLICC/ACR DI - SDI at visits 0, 1, and 2;
- Proportion of patients with prescribed average daily dose of oral corticosteroids at visits 0, 1 and 2
- Prednisone (and equivalents) = 0 mg/day
- Patients with corticosteroids >0, but less than 5 mg/day; mean daily dose of oral corticosteroids
- Patients with corticosteroids >5 mg/day: mean daily dose of oral corticosteroids
- Proportion of patients treated with each line of treatment [13] at visits 0, 1, and 2
- Glucocorticoids;
- Cytostatics;
- NSAIDs;
- Biological drugs;
- Immunoglobulins;
- Other significant drugs that affect the course of treatment.
Secondary Endpoints :
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 18 years and older with a verified diagnosis of SLE
- •Patient signed and dated written informed consent form (ICF) by ICH GCP and local legislation prior to inclusion in the study for the prospective observational group.
排除标准
- •Absence of a signed consent form (ICF) in patients
- •Cognitive impairments that hinder understanding the study objectives and completing questionnaires
- •Participation in any randomized controlled clinical trial within 3 months prior to inclusion or during participation in this study.
结局指标
主要结局
Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2
时间窗: 12 months
Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2
Proportion of patients with PGA changes in dynamics
时间窗: 12 months
Proportion of patients with PGA changes in dynamics
Proportion of patients with changes in dynamics in general clinical tests from baseline data (Visit 0) at visits 1 and 2
时间窗: 12 months
Proportion of patients with changes in dynamics in general clinical tests from baseline data (Visit 0) at visits 1 and 2
Proportion of patients with varying SLE organ damage assessed by SLICC/ACR Damage Index - SLICC/ACR DI - SDI at visits 0, 1, and 2
时间窗: 12 months
Proportion of patients with varying SLE organ damage assessed by SLICC/ACR Damage Index - SLICC/ACR DI - SDI at visits 0, 1, and 2
Proportion of patients (P) with prescribed average daily dose (dd) of oral corticosteroids(OC) at visits 0, 1 and 2 • Prednisone = 0 mg/day • P with OC >0 mg/day; mean dd of OC • P with OC >5 mg/day: mean dd of OC• P with OC ≤5 mg/day: mean dd of OC
时间窗: 12 months
Proportion of patients with prescribed average daily dose of oral corticosteroids at visits 0, 1 and 2 * Prednisone (and equivalents) = 0 mg/day * Patients with corticosteroids \>0 but less than 5 mg/day; mean daily dose of oral corticosteroids * Patients with corticosteroids \>5 mg/day: mean daily dose of oral corticosteroids prescribed average daily dose (dd) of oral corticosteroids(OC) at visits 0, 1 and 2 • Prednisone = 0 mg/day • P with OC \>0 mg/day; mean dd of OC • P with OC \>5 mg/day: mean dd of OC• P with OC ≤5 mg/day: mean dd of OC
Proportion of patients treated with each line of treatment [13] at visits 0, 1, and 2 • Glucocorticoids; • Cytostatics; • NSAIDs; • Biological drugs; • Immunoglobulins; • Other significant drugs that affect the course of treatment
时间窗: 12 months
Proportion of patients treated with each line of treatment \[13\] at visits 0, 1, and 2 * Glucocorticoids; * Cytostatics; * NSAIDs; * Biological drugs; * Immunoglobulins; * Other significant drugs that affect the course of treatment
Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2
时间窗: 12 months
Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2
Proportion of patients with PGA changes in dynamics
时间窗: 12 months
Proportion of patients with PGA changes in dynamics
Proportion of patients with changes in dynamics in general clinical tests from baseline data (Visit 0) at visits 1 and 2
时间窗: 12 months
Proportion of patients with changes in dynamics in general clinical tests from baseline data (Visit 0) at visits 1 and 2
Proportion of patients with varying SLE organ damage assessed by SLICC/ACR Damage Index - SLICC/ACR DI - SDI at visits 0, 1, and 2
时间窗: 12 months
Proportion of patients with varying SLE organ damage assessed by SLICC/ACR Damage Index - SLICC/ACR DI - SDI at visits 0, 1, and 2
Proportion of patients (P) with prescribed average daily dose (dd) of oral corticosteroids(OC) at visits 0, 1 and 2 • Prednisone = 0 mg/day • P with OC >0 mg/day; mean dd of OC • P with OC >5 mg/day: mean dd of OC• P with OC ≤5 mg/day: mean dd of OC
时间窗: 12 months
Proportion of patients with prescribed average daily dose of oral corticosteroids at visits 0, 1 and 2 * Prednisone (and equivalents) = 0 mg/day * Patients with corticosteroids \>0 but less than 5 mg/day; mean daily dose of oral corticosteroids * Patients with corticosteroids \>5 mg/day: mean daily dose of oral corticosteroids prescribed average daily dose (dd) of oral corticosteroids(OC) at visits 0, 1 and 2 • Prednisone = 0 mg/day • P with OC \>0 mg/day; mean dd of OC • P with OC \>5 mg/day: mean dd of OC• P with OC ≤5 mg/day: mean dd of OC
Proportion of patients treated with each line of treatment [13] at visits 0, 1, and 2 • Glucocorticoids; • Cytostatics; • NSAIDs; • Biological drugs; • Immunoglobulins; • Other significant drugs that affect the course of treatment
时间窗: 12 months
Proportion of patients treated with each line of treatment \[13\] at visits 0, 1, and 2 * Glucocorticoids; * Cytostatics; * NSAIDs; * Biological drugs; * Immunoglobulins; * Other significant drugs that affect the course of treatment
次要结局
未报告次要终点