Status:
COMPLETED
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Lead Sponsor:
AstraZeneca
Conditions:
Systemic Lupus Erythematosus
Eligibility:
FEMALE
18-45 years
Brief Summary
This study will be a non-interventional prospective study. Assessment of parameters will be carried out as if the patient is treated in a real-life clinical setting. The patients should be enrolled in...
Eligibility Criteria
Inclusion
- Women 18-45 years old
- Patients with reproductive issues in the past (early or late miscarriages, unexplained infertility)
- Clinical manifestation of a suspected connective tissue disorder.
- Women who were referred to a rheumatological settings as a part of a routine practice.
- Provided written informed consent before any study-related procedures are performed.
Exclusion
- Acute infectious disease or relapse of chronic infectious disease or other condition that can affect the immunological data accuracy according to physician decision,
- Previously confirmed by rheumatologist SLE or other immunoinflammatory disease including lupus nephritis and cutaneous or discoid lupus (acute or subacute).
Key Trial Info
Start Date :
September 28 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT06056778
Start Date
September 28 2023
End Date
June 17 2024
Last Update
February 28 2025
Active Locations (9)
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1
Research Site
Kazan', Russia
2
Research Site
Moscow, Russia
3
Research Site
Nizhny Novgorod, Russia
4
Research Site
Novosibirsk, Russia