AntiDFS70 Lupus Nephritis

Recruiting

• Conditions: Systemic Lupus Erythematosus
• Interventions: Diagnostic Test: anti dfs70 antibodies

• Registration Number: NCT06119763
• Lead Sponsor: Sohag University

Brief Summary

Systemic lupus erythematous (SLE) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the Reproductive years. In adults, the female to male ratio is 10- 15:1(1)( 2)

Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease. (3) (4) Anti-DFS70 antibodie) and their clinical associations remain an immunological paradox. Unlike other antinuclear antibodies , there is a growing body of evidence that anti-DFS70 antibodies, when present in high titers and in isolation (without accompanying other antibodies), are useful to aid in the exclusion of antinuclear antibodies associated rheumatic diseases. (8)

Anti-DFS70 antibodies were not associated with lupus nephritis development in Systemic lupus erythematosus patients but were associated with anti-dsDNA antibodies , proliferative lupus nephritis, and renal activity index . This suggests their potential to serve as a non-histological biomarker for lupus nephritis subclass and activity status. (8)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-15
• Status Verified: 2023-11
• Study First Submitted: 2023-11-01
• Study First Submitted QC: 2023-11-06
• Last Update Submitted: 2023-11-06
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-10-15
• Study Completion: 2024-10-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients who fulfill the 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematous . (9)

2. Patients who is able to give informed consent to join the study.

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Exclusion Criteria

• Any patient with any collagen disease other than systemic lupus erythematous

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
group B	anti dfs70 antibodies	systemic lupus erythematosus cases, diagnosed by SLICC criteria with positive levels of AntiDFS antibodies
group A	anti dfs70 antibodies	systemic lupus erythematosus cases, diagnosed by SLICC criteria with negative levels of AntiDFS antibodies

Primary Outcome Measures

Name	Time	Method
antiDFS70 antibodies titre	1 year	serve as a non-histological biomarker for lupus nephritis subclass and activity status.

Trial Locations

Locations (1)

Sohag university Hospital; 🇪🇬 Sohag, Egypt