Systemic Lupus ErythematosusPRISMANCT06056778
The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 9 sites in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 628 participants
- Where
- 9 sitesRussia
- Study dates
- 28 Sep 2023to 17 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Study population will consist of women 18-45 years old who had reproductive issues in the past (early or late miscarriages, unexplained infertility) and were referred to a rheumatological settings as a part of a routine practice due to a suspected immunologic cause of the reproductive problems. It is estimated that approximately 2000 patients will be enrolled in approximately 15 sites in Russian Federation.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Russia9 sites
Research Site
Kazan'
Research Site
Moscow
Research Site
Nizhny Novgorod
Research Site
Novosibirsk
Research Site
Orenburg
Research Site
Rostov-on-Don
Research Site
Saint Petersburg
Research Site
Ufa
Research Site
Voronezh
About this study
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.
Read more
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 inclusion/non-inclusion criteria will be offered to participate and sign the informed consent form (ICF). Initial patient's data input will be done retrospectively (case report forms [CRF] will be filled in, a patient's 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 patient's characteristics such as demographic data, clinical profile, detailed obstetric/reproductive 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): patient's data input will be done for enrolled patients.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, reproductive issues
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of confirmed SLE in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility).
The frequency of confirmed SLE in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility).
Measured: Up to 5 month
Secondary outcomes (1)
The frequency of ANA positive results in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility).
The frequency of ANA positive results in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility).
Measured: Up to 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start28 Sep 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06056778
- Sponsor's protocol ID
- D3461R00069
- Acronym
- PRISMA
- Status last verified
- Feb 2025
- First submitted
- 21 Sep 2023
- Last updated
- 28 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
- ClinicalTrials.gov ID
- NCT06056778
- Acronym / sponsor ID
- PRISMA / D3461R00069
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, reproductive issues
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 28 Sep 2023 (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.
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 inclusion/non-inclusion criteria will be offered to participate and sign the informed consent form (ICF). Initial patient's data input will be done retrospectively (case report forms [CRF] will be filled in, a patient's 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 patient's characteristics such as demographic data, clinical profile, detailed obstetric/reproductive 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): patient's data input will be done for enrolled patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Study population will consist of women 18-45 years old who had reproductive issues in the past (early or late miscarriages, unexplained infertility) and were referred to a rheumatological settings as a part of a routine practice due to a suspected immunologic cause of the reproductive problems. It is estimated that approximately 2000 patients will be enrolled in approximately 15 sites in Russian Federation.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
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
The frequency of confirmed SLE in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility).
Time frame: Up to 5 month
The frequency of confirmed SLE in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility).
1 secondary outcome
The frequency of ANA positive results in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility).
Time frame: Up to 5 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- D3461R00069 PRISMA Clinical Study Report (CSR) Synopsis RIMS.pdfLink provided by the sponsor.
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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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca at 9 sites in Russia.
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Russia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The frequency of confirmed SLE in women with certain clinical manifestations and reproductive issues (early or late miscarriages, unknown infertility). (time frame: Up to 5 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.