Observational study on the diagnosis and treatment of SLE in Kazakhstan
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.
This study looks at how systemic lupus erythematosus (SLE) is diagnosed and treated in Kazakhstan to better understand patient care and treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Drugs / interventions | Prednisone |
| Locations | 6 sites (Aktobe and 5 other locations) |
| Trial ID | NCT06899633 on ClinicalTrials.gov |
What this trial studies
This observational study aims to describe the diagnosis, course, and treatment of patients with systemic lupus erythematosus (SLE) in routine clinical practice across multiple centers in Kazakhstan. It will collect data both retrospectively and prospectively, focusing on various endpoints such as SLE activity, organ damage, and treatment regimens. The study will assess patient demographics, treatment responses, and changes in clinical parameters over time, providing valuable insights into SLE management in the region.
Who should consider this trial
Good fit: Ideal candidates include men and women aged 18 years and older with a verified diagnosis of SLE.
Not a fit: Patients who have cognitive impairments that hinder their understanding of the study or those who have participated in a randomized controlled trial within the last three months may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of SLE management and improve treatment strategies for patients in Kazakhstan.
How similar studies have performed: While this study is observational and descriptive, similar studies in other regions have provided valuable data on SLE management, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Aktobe and 5 other locations
- Research Site — Aktobe, Kazakhstan (Recruiting)
- Research Site — Almaty, Kazakhstan (Recruiting)
- Research Site — Almaty, Kazakhstan (Suspended)
- Research Site — Pavlodar, Kazakhstan (Not_yet_recruiting)
- Research Site — Semey, Kazakhstan (Recruiting)
- Research Site — Shymkent, Kazakhstan (Recruiting)
Study contacts
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.