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.

NCT06899633 | Active Not Recruiting

• 1 other identifier: D3461R00087
• Study Type: observational
• Target: 509
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Description of the Course of SLE in Patients in the Republic of Kazakhstan; Description of SLE Activity in Patients in Routine Practice in the Republic of Kazakhstan; Description of Methods and Approaches to the Treatment of Patients With SLE in the Republic of Kazakhstan

Outcome Measures

Primary Outcomes (6)

• Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2

  Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2

  12 months

• Proportion of patients with PGA changes in dynamics

  Proportion of patients with PGA changes in dynamics

  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 changes in dynamics in general clinical tests from baseline data (Visit 0) at visits 1 and 2

  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 with varying SLE organ damage assessed by SLICC/ACR Damage Index - SLICC/ACR DI - SDI at visits 0, 1, and 2

  12 months

• 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

  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

  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 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

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This non-interventional, multicenter observational study will enroll 500 adult patients with established SLE who are being followed and treated by rheumatologists in approximately 10 outpatient sites in approximately 8 regions of Kazakhstan. Eligible patients will be recruited sequentially during routine hospital visits. There will be no patient recruitment restrictions per site or region (to minimize selection bias at each site).

You may qualify if:

• Men and women aged 18 years and older with a verified diagnosis of SLE

You may not qualify if:

• Absence of a signed consent form (ICF) in patients
• Cognitive impairments that hinder understanding the study objectives and completing questionnaires

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (12)

State Enterprise on the Right of Economic Management - Aktobe Medical Center

Aktobe, Kazakhstan

Location

ESEM Pharmacy LLP

Almaty, Kazakhstan

Location

JSC Research Institute of Cardiology and Internal Diseases

Almaty, Kazakhstan

Location

Municipal state enterprise with the right of economic management City polyclinic No. 5

Almaty, Kazakhstan

Location

Non-Profit Joint Stock Company Kazakh National Medical University named after S.D. Asfendiyarov

Almaty, Kazakhstan

Location

Republican Diagnostic Center of Astana Corporate Fund University Medical Center

Astana, Kazakhstan

Location

Municipal State Enterprise on the Right of Economic Management - Pavlodar Regional Hospital named after G. Sultanov

Pavlodar, Kazakhstan

Location

Non-Profit Joint Stock Company Semey Medical University - University Hospital

Semey, Kazakhstan

Location

Medical Center for Joint Diseases of Shymkent LLP

Shymkent, Kazakhstan

Location

State Enterprise on the Right of Economic Management - Regional Clinical Hospital of the Turkestan Region

Shymkent, Kazakhstan

Location

State-owned enterprise on the right of economic management -Taldykorgan City Polyclinic

Taldykorgan, Kazakhstan

Location

Zhambyl Regional Multidisciplinary Hospital of the Health Department of the Akimat of Zhambyl Region

Taraz, -- Select --, Kazakhstan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: March 28, 2025
• Study Start: May 15, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

KA (12)