Clinical Trial on SLE - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

SLE

Detailed 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

Study Type

Observational

Enrollment (Anticipated)

52

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Fatma Al-zahraa M. Abdel-bary, resident
Phone Number: 0201014363853
Email: Zahraamustafa22@yahoo.com

Study Contact Backup

Name: Sherif H. Jalal, professor
Phone Number: 0201222675000
Email: Sherif_h918@hotmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any patients fulfillef the critria o 2012 SLE international collaborating clinics and admition to Assiut University are participate in this study .

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of serum interleukin-26 level . Time Frame: baseline	Assessment of serum interleukin-26 level in SLE patients and compare it with the serum interleukin-26 level in healthy	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association !! Time Frame: baseline	Association of serum interleukin 26 with SLE activity and severity.	baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 10, 2021

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

May 1, 2025

Study Registration Dates

First Submitted

December 4, 2021

First Submitted That Met QC Criteria

December 16, 2021

First Posted (Actual)

December 17, 2021

Study Record Updates

Last Update Posted (Actual)