AntiDFS70 Lupus Nephritis

Systemic Lupus Erythematosus Clinical Trial

Official title:

Anti-DFS70 Antibodies and it's Relationship With Systemic Lupus Erythematosus Manifestations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119763
• Other study ID #: Soh-Med-23-10-011MS
• Status: Recruiting
• Start date: October 15, 2023
• Est. completion date: October 25, 2024

Study information

• Verified date: November 2023
• Source: Sohag University
• Contact: ashrakat s Mohammed, resident
• Phone: 01005046015
• Email: ashraketshaaban[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 25, 2024
• Est. primary completion date: October 15, 2024
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

•

Exclusion Criteria:

-

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• anti dfs70 antibodies
blood sample is taken from SLE cases and is tested for antiDFS70 antibodies titre

Locations

Country	Name	City	State
Egypt	Sohag university Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

DUBOIS EL, TUFFANELLI DL. CLINICAL MANIFESTATIONS OF SYSTEMIC LUPUS ERYTHEMATOSUS. COMPUTER ANALYSIS OF 520 CASES. JAMA. 1964 Oct 12;190:104-11. doi: 10.1001/jama.1964.03070150014003. No abstract available. — View Citation

Hahn BH, McMahon MA, Wilkinson A, Wallace WD, Daikh DI, Fitzgerald JD, Karpouzas GA, Merrill JT, Wallace DJ, Yazdany J, Ramsey-Goldman R, Singh K, Khalighi M, Choi SI, Gogia M, Kafaja S, Kamgar M, Lau C, Martin WJ, Parikh S, Peng J, Rastogi A, Chen W, Grossman JM; American College of Rheumatology. American College of Rheumatology guidelines for screening, treatment, and management of lupus nephritis. Arthritis Care Res (Hoboken). 2012 Jun;64(6):797-808. doi: 10.1002/acr.21664. No abstract available. — View Citation

Lim SS, Bayakly AR, Helmick CG, Gordon C, Easley KA, Drenkard C. The incidence and prevalence of systemic lupus erythematosus, 2002-2004: The Georgia Lupus Registry. Arthritis Rheumatol. 2014 Feb;66(2):357-68. doi: 10.1002/art.38239. — View Citation

Pons-Estel GJ, Alarcon GS, Scofield L, Reinlib L, Cooper GS. Understanding the epidemiology and progression of systemic lupus erythematosus. Semin Arthritis Rheum. 2010 Feb;39(4):257-68. doi: 10.1016/j.semarthrit.2008.10.007. Epub 2009 Jan 10. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	antiDFS70 antibodies titre	serve as a non-histological biomarker for lupus nephritis subclass and activity status.	1 year