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NCT07144514Not yet recruiting

Observational Study Investigating Demographic and Clinical Characteristics of SLE Patients in Egypt

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

Source: ClinicalTrials.gov · Last updated 27 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
276 (estimated)
First submitted
13 May 2025
Start date
31 Aug 2025
Primary completion date
31 Dec 2025
Lead sponsor
AstraZeneca
Diseases
Lupus (SLE)
NCT number
NCT07144514

What you commit to

  • Study type: Observational
  • Planned participants: 276
  • From 31 Aug 2025 to the primary completion date, 31 Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Patients with new-onset SLE as they will have insufficient data.
  • Patients whose records have insufficient data (for example, due to lost follow up).

Who the study is looking for

  • 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.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.