Description of SLE Activity in Patients in Routine Practice in the Republic of KazakhstanNCT06899633

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.

An observational study of Description of SLE Activity in Patients in Routine Practice in the Republic of Kazakhstan and Description of the Course of SLE in Patients in the Republic of Kazakhstan, run by AstraZeneca at 12 sites in Kazakhstan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Description of SLE Activity in Patients in Routine Practice in the Republic of Kazakhstan, Description of the Course of SLE in Patients in the Republic of Kazakhstan, Description of Methods and Approaches to the Treatment of Patients With SLE in the Republic of Kazakhstan
How many people: 509 participants
Where: 12 sitesKazakhstan
Study dates: 15 May 2025to 28 Feb 2027
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Kazakhstan12 sites

State Enterprise on the Right of Economic Management - Aktobe Medical Center
Aktobe
ESEM Pharmacy LLP
Almaty
JSC Research Institute of Cardiology and Internal Diseases
Almaty
Municipal state enterprise with the right of economic management City polyclinic No. 5
Almaty
Non-Profit Joint Stock Company Kazakh National Medical University named after S.D. Asfendiyarov
Almaty
Republican Diagnostic Center of Astana Corporate Fund University Medical Center
Astana
Municipal State Enterprise on the Right of Economic Management - Pavlodar Regional Hospital named after G. Sultanov
Pavlodar
Non-Profit Joint Stock Company Semey Medical University - University Hospital
Semey
Medical Center for Joint Diseases of Shymkent LLP
Shymkent
State Enterprise on the Right of Economic Management - Regional Clinical Hospital of the Turkestan Region
Shymkent
State-owned enterprise on the right of economic management -Taldykorgan City Polyclinic
Taldykorgan
Zhambyl Regional Multidisciplinary Hospital of the Health Department of the Akimat of Zhambyl Region
Taraz, -- Select --

Other trials in Kazakhstan

About this study

Read the detailed description

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 :

Proportion of each sex among patients with SLE 2. Proportion of patients in different age groups 3. Proportion of patients of different races 4. Proportion of patients belonging to different nationalities 5. Proportion of patients with different social status groups 6. Proportion of patients in different BMI classes [9] 7. Proportion of patients with different ages of SLE onset and disease duration at diagnosis

SLE course (relapsing-remitting, chronically active course; SLE remission)
SLE disease activity (high, moderate, low)
Average number of SLE exacerbations in the past year;
Number and reasons for SLE-related hospitalizations and emergency department visits [11]
Number and reasons for non-SLE-related hospitalizations;
Number and percentage of patients with affected organs (kidneys, lungs, heart, nervous system, hematopoietic system, skin [10])
Changes in the Revised Cutaneous Lupus Erythematosus Disease Areas and Severity Index (R-CLASI) scores 8 Dynamics of treatment results in patients with SLE:
proportion of patients who achieved remission;
proportion of patients with a decrease in the degree of SLE activity;
proportion of patients who achieved low disease activity;
proportion of patients with various reasons for stopping therapy
proportion of patients switching drugs 9. Changes in quality of life indicators based on quality of life questionnaires and the presence of fatigue: Questionnaire (LupusQoL) for SLE at visits 0, 1 and 2.

Proportion of patients achieving the combined endpoint LLDAS7.5 at baseline, visits 0, 1, and 2 (LLDAS with prednisone equivalent needed for response ≤ 7.5 mg/day) 11. Proportion of patients achieving the combined endpoint LLDAS5 at baseline, visits 0, 1, and 2 (LLDAS with prednisone equivalent needed for response ≤ 5 mg/day) 12. Proportion of patients achieving clinical remission at baseline, visits 0, 1, and 2.
Changes in symptoms and clinical manifestations in patients with SLE 14. Changes in complications in patients with SLE 15. Proportion of patients with lupus nephritis 16. Changes in non-specific laboratory parameters (at visits 1 and 2 from the initial (visit 0)):

Complete blood count (CBC);
Complete urine count (CUA);
Coagulogram;
biochemical blood test: creatinine, total protein, ALT, AST, total bilirubin, total cholesterol, glucose;
CRP
GFR 17. Changes in immunological criteria:
Indicators of C3, C4 components of the complement system at visits 0.1 and 2;
IgG antibodies to double-stranded (native) DNA at visits 0, 1 and 2
Antinuclear factor on the HEp-2 cell line (ANF) at visits 0 and 2 18. The proportion of patients adherent to treatment based on the Morisky-Green Questionnaire 19. The proportion of patients who had hospitalization and/or an emergency department visit [11] 20. The percentage of various reasons for SLE and non-SLE hospitalizations

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 months
Proportion of patients with PGA changes in dynamics
Proportion of patients with PGA changes in dynamics
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 202528 Feb 2027

First posted28 Mar 2025
Study start15 May 2025
Primary completion28 Feb 2027 (estimated)
Study completion28 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Description of SLE Activity in Patients in Routine Practice in the Republic of KazakhstanStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 509 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06899633
Sponsor's protocol ID: D3461R00087
Status last verified: Sep 2026
First submitted: 26 Mar 2025
Last updated: 11 Sep 2026
Results posted: No
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Study at a glance

From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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.
ClinicalTrials.gov ID: NCT06899633
Acronym / sponsor ID: D3461R00087
Conditions: Description of SLE Activity in Patients in Routine Practice in the Republic of Kazakhstan, Description of the Course of SLE in Patients in the Republic of Kazakhstan, Description of Methods and Approaches to the Treatment of Patients With SLE in the Republic of Kazakhstan
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 509 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 15 May 2025 (actual)
Primary completion: 28 Feb 2027 (estimated)
Study completion: 28 Feb 2027 (estimated)
First posted: 28 Mar 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 :

Proportion of each sex among patients with SLE 2. Proportion of patients in different age groups 3. Proportion of patients of different races 4. Proportion of patients belonging to different nationalities 5. Proportion of patients with different social status groups 6. Proportion of patients in different BMI classes [9] 7. Proportion of patients with different ages of SLE onset and disease duration at diagnosis

SLE course (relapsing-remitting, chronically active course; SLE remission)
SLE disease activity (high, moderate, low)
Average number of SLE exacerbations in the past year;
Number and reasons for SLE-related hospitalizations and emergency department visits [11]
Number and reasons for non-SLE-related hospitalizations;
Number and percentage of patients with affected organs (kidneys, lungs, heart, nervous system, hematopoietic system, skin [10])
Changes in the Revised Cutaneous Lupus Erythematosus Disease Areas and Severity Index (R-CLASI) scores 8 Dynamics of treatment results in patients with SLE:
proportion of patients who achieved remission;
proportion of patients with a decrease in the degree of SLE activity;
proportion of patients who achieved low disease activity;
proportion of patients with various reasons for stopping therapy
proportion of patients switching drugs 9. Changes in quality of life indicators based on quality of life questionnaires and the presence of fatigue: Questionnaire (LupusQoL) for SLE at visits 0, 1 and 2.

Proportion of patients achieving the combined endpoint LLDAS7.5 at baseline, visits 0, 1, and 2 (LLDAS with prednisone equivalent needed for response ≤ 7.5 mg/day) 11. Proportion of patients achieving the combined endpoint LLDAS5 at baseline, visits 0, 1, and 2 (LLDAS with prednisone equivalent needed for response ≤ 5 mg/day) 12. Proportion of patients achieving clinical remission at baseline, visits 0, 1, and 2.
Changes in symptoms and clinical manifestations in patients with SLE 14. Changes in complications in patients with SLE 15. Proportion of patients with lupus nephritis 16. Changes in non-specific laboratory parameters (at visits 1 and 2 from the initial (visit 0)):

Complete blood count (CBC);
Complete urine count (CUA);
Coagulogram;
biochemical blood test: creatinine, total protein, ALT, AST, total bilirubin, total cholesterol, glucose;
CRP
GFR 17. Changes in immunological criteria:
Indicators of C3, C4 components of the complement system at visits 0.1 and 2;
IgG antibodies to double-stranded (native) DNA at visits 0, 1 and 2
Antinuclear factor on the HEp-2 cell line (ANF) at visits 0 and 2 18. The proportion of patients adherent to treatment based on the Morisky-Green Questionnaire 19. The proportion of patients who had hospitalization and/or an emergency department visit [11] 20. The percentage of various reasons for SLE and non-SLE hospitalizations

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (3 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2 (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06899633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.