Systemic Lupus ErythematosusROSENCT07144514
Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca.
Trial summary
Systemic lupus erythematosus (SLE) is an autoimmune condition characterized by a complicated, unclear etiology that involves various complex factors. SLE symptoms and indications are broadly classified as organ-specific and constitutional (arising from systemic inflammation). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 276 participants
- Where
- No sites listed yet
- Study dates
- 31 Aug 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will include adult patients diagnosed with SLE in different geographic areas of Egypt who meet all the specified inclusion criteria and none of the exclusion criteria for this study. The study population should be selected without bias.
Who may be able to join
- Adults of both genders aged 18 or older at the time of study inclusion.
- Patients with medical records from the selected sites between 2016 and 2023 with at least one year of follow-up records.
- Patients receiving routine treatment in the participating sites.
- Patients with an SLE diagnosis.
- Due to the retrospective nature of the study a waiver grant of the consent will be requested from the IRB/IEC for the study participants, if waiver not granted Patient or next of kin/legal representative (for deceased patients at study entry) willing and able to provide written informed consent according to the local regulations.
Who cannot join
- Patients with new-onset SLE as they will have insufficient data.
- Patients whose records have insufficient data (for example, due to lost follow up).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
AstraZeneca Clinical Study Information Center contact
About this study
Official title: A Retrospective Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt: Unveiling the Burden, Reasons for Hospitalization, and ER Visits in Participating Centers
Systemic lupus erythematosus (SLE) is an autoimmune condition characterized by a complicated, unclear etiology that involves various complex factors. SLE symptoms and indications are broadly classified as organ-specific and constitutional (arising from systemic inflammation). While fever, weight loss, and elevated body temperature are constitutional symptoms that patients with SLE may encounter, SLE may affect specific organs, including the lungs, heart, kidneys, and muscles, as well as the hematologic and central nervous systems. If left untreated, SLE-related local inflammation may result in permanent organ damage. Individuals diagnosed with SLE frequently encounter instances of heightened disease activity, commonly referred to as disease exacerbations or flares. Flares are described as "a distinct surge in disease activity affecting one or more organ systems, as demonstrated by an onset of novel or worsening clinical symptoms and/or laboratory findings". Due to the complex trajectory of SLE, patients may have a higher likelihood of visiting the emergency room (ER) because of flare-ups, adverse drug reactions, and noncompliance with prescribed treatment regimens. Furthermore, SLE has a high cumulative morbidity and mortality rate, and comorbidities linked to the disease have become a major cause of late deaths in SLE. Although the prevalence of SLE varies by age, gender, and geographical distribution, the global prevalence of SLE was estimated to be 43.7% (15.87 to 108.92) per 100,000 individuals and 3.41 million individuals for the entire population. A recent study by Gheita et al. estimated the prevalence of SLE among adults in Egypt to be 6.1 per 100,000; however, the researchers highlighted the scarcity of published epidemiological studies on the Egyptian SLE patient population, and the available data is based mostly on single-center studies with small sample sizes. Thus, the available data is not representative of the whole nation. This study aims to overcome these issues and address the data gap regarding the SLE patient population in Egypt.
- Conditions
- Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the lupus-affected population
patients gender, age, and percentage of patients with affected organs, as well as medications taken.
Measured: 60 months
Determining the burden of SLE in Egypt
The average number of SLE flares
Measured: 60 months
Secondary outcomes (1)
Mortality rate
Percentage of mortality within the duration of data collection and reason for mortality (all-cause mortality, SLE-related manifestation, mortality due to comorbidities or medications).
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start31 Aug 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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
- Retrospective
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07144514
- Sponsor's protocol ID
- D3461R00088
- Acronym
- ROSE
- Status last verified
- Aug 2025
- First submitted
- 13 May 2025
- Last updated
- 27 Aug 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 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt: Unveiling the Burden, Reasons for Hospitalization, and ER Visits in Participating Centers
- ClinicalTrials.gov ID
- NCT07144514
- Acronym / sponsor ID
- ROSE / D3461R00088
- Conditions
- Systemic Lupus Erythematosus
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Aug 2025 (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.
Systemic lupus erythematosus (SLE) is an autoimmune condition characterized by a complicated, unclear etiology that involves various complex factors. SLE symptoms and indications are broadly classified as organ-specific and constitutional (arising from systemic inflammation). While fever, weight loss, and elevated body temperature are constitutional symptoms that patients with SLE may encounter, SLE may affect specific organs, including the lungs, heart, kidneys, and muscles, as well as the hematologic and central nervous systems. If left untreated, SLE-related local inflammation may result in permanent organ damage. Individuals diagnosed with SLE frequently encounter instances of heightened disease activity, commonly referred to as disease exacerbations or flares. Flares are described as "a distinct surge in disease activity affecting one or more organ systems, as demonstrated by an onset of novel or worsening clinical symptoms and/or laboratory findings". Due to the complex trajectory of SLE, patients may have a higher likelihood of visiting the emergency room (ER) because of flare-ups, adverse drug reactions, and noncompliance with prescribed treatment regimens. Furthermore, SLE has a high cumulative morbidity and mortality rate, and comorbidities linked to the disease have become a major cause of late deaths in SLE. Although the prevalence of SLE varies by age, gender, and geographical distribution, the global prevalence of SLE was estimated to be 43.7% (15.87 to 108.92) per 100,000 individuals and 3.41 million individuals for the entire population. A recent study by Gheita et al. estimated the prevalence of SLE among adults in Egypt to be 6.1 per 100,000; however, the researchers highlighted the scarcity of published epidemiological studies on the Egyptian SLE patient population, and the available data is based mostly on single-center studies with small sample sizes. Thus, the available data is not representative of the whole nation. This study aims to overcome these issues and address the data gap regarding the SLE patient population in Egypt.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will include adult patients diagnosed with SLE in different geographic areas of Egypt who meet all the specified inclusion criteria and none of the exclusion criteria for this study. The study population should be selected without bias.
Key inclusion criteria (5 listed)
- Adults of both genders aged 18 or older at the time of study inclusion.
- Patients with medical records from the selected sites between 2016 and 2023 with at least one year of follow-up records.
- Patients receiving routine treatment in the participating sites.
- Patients with an SLE diagnosis.
- Due to the retrospective nature of the study a waiver grant of the consent will be requested from the IRB/IEC for the study participants, if waiver not granted Patient or next of kin/legal representative (for deceased patients at study entry) willing and able to provide written informed consent according to the local regulations.
Key exclusion criteria (2 listed)
- Patients with new-onset SLE as they will have insufficient data.
- Patients whose records have insufficient data (for example, due to lost follow up).
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
Description of the lupus-affected population
Time frame: 60 months
patients gender, age, and percentage of patients with affected organs, as well as medications taken.
Determining the burden of SLE in Egypt
Time frame: 60 months
The average number of SLE flares
1 secondary outcome
Mortality rate
Time frame: 60 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
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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.
AstraZeneca Clinical Study Information Center contact
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by AstraZeneca.
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: opening soon, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Description of the lupus-affected population (time frame: 60 months). The study lists 2 primary outcomes in all. 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 27 Aug 2025.