Serum IL 26 as a Marker of Disease Activity in SLE

SLE Clinical Trial

Official title:

Serum IL 26 as a Marker of Disease Activity in SLE

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05161988
• Other study ID #: SLE IL26
• Status: Not yet recruiting
• Start date: December 10, 2021
• Est. completion date: May 1, 2025

Study information

• Verified date: December 2021
• Source: Assiut University
• Contact: Fatma Al-zahraa M. Abdel-bary, resident
• Phone: 0201014363853
• Email: Zahraamustafa22[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Assessment of serum Interleukin 26 level in SLE patients and compare it with healthy controls.

Association of serum interleukin 26 with SLE activity and severity.

Description:

Systemic lupus erythematosus (SLE) is a chronic inflammatory disease characterized by diverse autoantibodies and varied clinical manifestations(mainly targeting the skin, kidneys, and brain). Autoantibodies directed against double-stranded (ds) DNA play a key role in the initiation and maintenance of inflammatory lesions in SLE(1).

Pathogenesis of SLE is mirrored by its complex aetiopathogenesis as genetic factors , environmental triggers (exposure to sunlight, drugs and infections, particularly with Epstein-Barr virus. . Causing secretion of inflammatory mediators , antibody and cytokines . But still pathological mechanisms of SLE are still not fully understood. (2) Immune system dysregulation such as incomplete clearance of apoptotic materials, hyperactivation of immune cells, overproduction of antibodies and abundant immune complex deposits are prominent in SLE (3) Clinical manifestations of SLE are Malar rash, Discoid rash ,Photosensitivity, Oral or nasopharyngeal ulcers, Pleurisy, Renal abnormalities, Immunologic abnormalities, Nonscarring alopecia, Synovitis, Hemolytic anemia, Leukopenia, Thrombocytopenia Proteinuria Seizures Psychosis Serositis and Arthritis (4) IL-26 is a 171-amino acid protein that belongs to the IL-10 family of cytokines, a family that includes IL-10, IL-19, IL-20, IL-22 and IL-24 . The IL-26 protein is encoded by the IL26 gene located on chromosome 12q15 between genes for interferon (IFN)-γ and IL-22 , and is conserved in several vertebrate species but not in mice and rats . The cytokine IL-26 was originally named AK155(5) IL-26 was initially identified as a pro-inflammatory cytokine , inducing the production of inflammatory cytokines by myeloid cells that are involved in the differentiation of naïve CD4+ T cells into Th17 cells (6) The involvement of IL 26 in numerous chronic auto inflammatory diseases and in two major pathogenic processes in SLE, namely the induction of IFN I and its production by Th 17 lymphocytes, makes the analysis of its role in SLE essential (7) Brilland et al., 2021 report that the levels of IL 26 are higher in SLE patients than healthy subjects and show a significant correlation with disease activity

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: May 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult SLE Patients who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

Exclusion Criteria:

• Individuals with other autoimmune diseases (rheumatoid arthritis dermatomyositis, scleroderma, mixed connective tissue disease).

Related Conditions & MeSH terms

• SLE

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

Knappe A, Hör S, Wittmann S, Fickenscher H. Induction of a novel cellular homolog of interleukin-10, AK155, by transformation of T lymphocytes with herpesvirus saimiri. J Virol. 2000 Apr;74(8):3881-7. — View Citation

Maidhof W, Hilas O. Lupus: an overview of the disease and management options. P T. 2012 Apr;37(4):240-9. — View Citation

Manson JJ, Rahman A. Systemic lupus erythematosus. Orphanet J Rare Dis. 2006 Mar 27;1:6. Review. — View Citation

Roberts AL, Rizzolo D. Systemic lupus erythematosus: an update on treat-to-target. JAAPA. 2015 Sep;28(9):22-8. doi: 10.1097/01.JAA.0000470432.76823.93. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of serum interleukin-26 level .	Assessment of serum interleukin-26 level in SLE patients and compare it with the serum interleukin-26 level in healthy	baseline
Secondary	Association !!	Association of serum interleukin 26 with SLE activity and severity.	baseline