Ignite Creation Date:
2024-05-06 @ 7:34 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06056778
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2023-09-21
Brief Title:
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues PRISMA
Sponsor:
AstraZeneca
Organization:
AstraZeneca
Study Overview
Official Title:
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues PRISMA
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISMA
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 into this project after evaluation of eligibility criteria by the investigator in clinical sites who have an experience in management of patients with SLE No additional procedures besides those already used in the routine clinical practice will be applied to the patients
The purpose of this study is to estimate prevalence of confirmed SLE in patients in rheumatological settings who has the reproductive issues and certain clinical and laboratory manifestations specific for immunoinflammatory diseases in Russia
We will follow all the local regulatory requirements regarding adverse event reporting pharmacovigilance
It is planned to enrol 2000 patients in clinical sites in Russian Federation N 15
The study will include two visits During the screening visit women who meet the inclusionnon-inclusion criteria will be offered to participate and sign the informed consent form ICF Initial patients data input will be done retrospectively case report forms CRF will be filled in a patients visit will be conducted in accordance with the routine practice and healthcare professionals HCPs recommendations on an individual basis An experienced rheumatologist will collect the baseline patients characteristics such as demographic data clinical profile detailed obstetricreproductive history Women who had pregnancies in the past will be asked about the course of all pregnancies and their outcomes Women will be asked to provide the corresponding medical records or discharge summaries if possible in order to input the data from them into the CRFs the documents will be given back to women at the same visit The immunologic blood test will be conducted in the reference laboratory According to clinical examination and laboratory test results ANA immunoassay for specific antibodies anti-Sm and-dsDNA antiphospholipid antibodies anticardiolipin antibodies anti-β3GP1 antibodies lupus anticoagulant complement components C3 C4 etc SLE diagnosis will be made or rejected
One follow-up visit will be conducted for those women who were referred to a laboratory testing for SLE The visit will include the laboratory analyses assessment by an experienced rheumatologist with a subsequent confirmation or rejection of the SLE diagnosis
The last date of enrolment - Dec 2023 Last patient last visit approximately 4 months from the study start patients data input will be done for enrolled patients
The purpose of this study is to estimate prevalence of confirmed SLE in patients in rheumatological settings who has the reproductive issues and certain clinical and laboratory manifestations specific for immunoinflammatory diseases in Russia
We will follow all the local regulatory requirements regarding adverse event reporting pharmacovigilance
It is planned to enrol 2000 patients in clinical sites in Russian Federation N 15
The study will include two visits During the screening visit women who meet the inclusionnon-inclusion criteria will be offered to participate and sign the informed consent form ICF Initial patients data input will be done retrospectively case report forms CRF will be filled in a patients visit will be conducted in accordance with the routine practice and healthcare professionals HCPs recommendations on an individual basis An experienced rheumatologist will collect the baseline patients characteristics such as demographic data clinical profile detailed obstetricreproductive history Women who had pregnancies in the past will be asked about the course of all pregnancies and their outcomes Women will be asked to provide the corresponding medical records or discharge summaries if possible in order to input the data from them into the CRFs the documents will be given back to women at the same visit The immunologic blood test will be conducted in the reference laboratory According to clinical examination and laboratory test results ANA immunoassay for specific antibodies anti-Sm and-dsDNA antiphospholipid antibodies anticardiolipin antibodies anti-β3GP1 antibodies lupus anticoagulant complement components C3 C4 etc SLE diagnosis will be made or rejected
One follow-up visit will be conducted for those women who were referred to a laboratory testing for SLE The visit will include the laboratory analyses assessment by an experienced rheumatologist with a subsequent confirmation or rejection of the SLE diagnosis
The last date of enrolment - Dec 2023 Last patient last visit approximately 4 months from the study start patients data input will be done for enrolled patients
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None