NCT07144514: ROSE

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

Not yet recruiting Last updated 27 August 2025

What this trial tests

trial in Systemic Lupus Erythematosus in 276 participants. Not yet recruiting.

Timeline

31 August 2025

Primary endpoint
31 December 2025

31 December 2025

Quick facts

Lead sponsor	AstraZeneca
Status	Not yet recruiting
Study type	OBSERVATIONAL
Enrollment	276
Start date	31 August 2025
Primary completion	31 December 2025
Estimated completion	31 December 2025

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

AstraZeneca — full company profile →

Who can join

Eligibility, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.