A Study of ATG-201 in Adult Participants With Autoimmune Diseases
NCT07732309
Arthritis, Arthritis, Rheumatoid
Bengbu, Anhui, China
View Trial DetailsNCT Number: NCT07144514
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.
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Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 60 months
patients gender, age, and percentage of patients with affected organs, as well as medications taken.
Time frame: 60 months
The average number of SLE flares
Time frame: 60 Months
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).
Time frame: 60 Months
The duration of each treatment line and any observed outcomes
Time frame: 60 Months
The proportion and percentage of patients suffering from an increase/emergence of SLE manifestations
Contact information is provided by the study sponsor or research team.
AstraZeneca
Industry
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
Acronym: ROSE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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