Status:

RECRUITING

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.

Lead Sponsor:

AstraZeneca

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

Eligibility:

All Genders

18+ years

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 compone...

Detailed Description

Primary Endpoints 1. Proportion of patients with varying SLE activity assessed by the SLEDAI 2K Activity Index at visits 0, 1, and 2 2. Proportion of patients with PGA changes in dynamics 3. Proporti...

Eligibility Criteria

Inclusion

  • Inclusion Criteria
  • 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.
  • Exclusion Criteria
  • 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.

Exclusion

    Key Trial Info

    Start Date :

    May 15 2025

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    February 28 2027

    Estimated Enrollment :

    500 Patients enrolled

    Trial Details

    Trial ID

    NCT06899633

    Start Date

    May 15 2025

    End Date

    February 28 2027

    Last Update

    January 8 2026

    Active Locations (12)

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    Page 1 of 3 (12 locations)

    1

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

    Aktobe, Kazakhstan

    2

    ESEM Pharmacy LLP

    Almaty, Kazakhstan

    3

    JSC Research Institute of Cardiology and Internal Diseases

    Almaty, Kazakhstan

    4

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

    Almaty, Kazakhstan