Evaluation of Janus Kinase_3 in Juvenile Onset Systemic Lupus Erythematosus

• Conditions: Systemic Lupus Erythematosus
• Interventions: Procedure: renal biopsy and blood sampling

• Registration Number: NCT04293510
• Lead Sponsor: Assiut University

Brief Summary

One of the best understood mechanisms by which cytokines activate signals, thus eliciting specific responses in target cells, involves enzymes such as Janus kinases (JAKs) and transcriptional factors such as signal transducers and activators of transcription (STATs). For immune mediated diseases, both activating and inactivating mutations of JAKs and STATs may cause abnormalities in immune homeostasis. Polymorphisms of JAK/STAT genes have been linked to susceptibility for rheumatoid arthritis (RA) , systemic lupus erythematosus (SLE), psoriatic arthritis (PA) and inflammatory bowel disease (IBD) .

Janus_kinase 3 expression will be evaluated in the serum and renal tissue of lupus patients during active stage of the disease through this study

Detailed Description

Investigators will assess the relationship between the expression of Janus_kinase 3 and the clinical and laboratory parameters of disease activity . Disease activity will be assessed through the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI). Also, investigators will evaluate the relationship between Janus_ kinase 3 expression and histopathological classes of lupus nephritis according to the 2003 International Society of Nephrology/ Renal Pathology Society (ISN/RPS) classification of lupus nephritis. This will be done through Janus_kinase 3 assessment in the blood and renal tissue of lupus patients.

Study Timeline

• Study First Submitted: 2020-02-29
• Study First Submitted QC: 2020-02-29
• Status Verified: 2020-03
• Study First Posted: 2020-03-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-04
• Study Start: 2020-07-15
• Primary Completion: 2021-07-15
• Study Completion: 2022-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Age younger than 16 years.

  • Active disease stage
  • Patients with biopsy proven lupus nephritis according to ISN/RPS classification criteria of lupus nephritis

Exclusion Criteria

• Lupus patients in remission.

  • Lupus patients with end stage renal disease.
  • Lupus patients with secondary thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS).
  • patients with moderate or severe infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group study 1	renal biopsy and blood sampling	children and adolescents who diagnosed as lupus patients

Primary Outcome Measures

Name	Time	Method
Janus-kinase 3 expression	within 2 years	evaluation of Janus-kinase 3 expression in blood and renal tissue of lupus patients during active stage of disease

Secondary Outcome Measures

Name	Time	Method
correlation	2 years	relationship between Janus- kinase expression and clinical and laboratory parameters of disease activity