Efficacy and Safety of CRC01 in Participants With Severe, Refractory Systemic Lupus Erythematosus
NCT07364396
Autoimmune Diseases, Connective Tissue Diseases
View Trial DetailsNCT Number: NCT07149402
This is a case-control study investigating serum IL-33 levels and their association with clinical manifestations in systemic lupus erythematosus (SLE). The study compares IL-33 levels in three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and healthy controls. The goal is to clarify IL-33's role as a biomarker reflecting disease activity and organ involvement, especially renal pathology.
Trial opening soon.
Get NotifiedSystemic lupus erythematosus (SLE) is a chronic autoimmune disease with variable clinical presentations, ranging from mild symptoms to life-threatening organ damage. Lupus nephritis, a severe renal manifestation of SLE, significantly contributes to morbidity and mortality. IL-33, a cytokine from the IL-1 family, has been implicated in immune regulation and inflammation, emerging as a potential marker in SLE pathogenesis and progression.
This study systematically evaluates serum IL-33 levels in 96 participants divided into three groups: SLE patients with lupus nephritis, SLE patients without nephritis, and matched healthy controls. The study is conducted over one year at the Rheumatology Department of Assiut University Hospital. It includes clinical assessments, laboratory investigations (including ELISA for IL-33, autoantibody profiles, renal function), renal Doppler ultrasound for nephritis patients, and renal biopsy analyzed using ISN/RPS classification.
By assessing IL-33 levels alongside clinical manifestations, disease activity indices, and histopathological findings, the study aims to define IL-33's diagnostic and prognostic utility in lupus nephritis and overall SLE disease monitoring. Statistical analysis with SPSS includes ANOVA and correlation tests to detect differences and associations.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline
Quantification of serum IL-33 concentrations using a high-sensitivity ELISA kit across three groups: healthy controls, SLE patients without nephritis, and SLE patients with nephritis.
Assiut University
Other
Serum Interleukin-33 (IL-33) Levels and Their Association With Clinical Manifestations in Patients With Systemic Lupus Erythematosus and Lupus Nephritis at Assiut University Hospital
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
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.
Published trials that share one or more normalized conditions with this study.
NCT07364396
Autoimmune Diseases, Connective Tissue Diseases
View Trial DetailsNCT06872086
Autoimmune Diseases, Blood Indices
View Trial DetailsNCT06581029
SLE
View Trial DetailsNCT07260877
Autoimmune Diseases, CLE
Beverly Hills, California, United States
View Trial Details