Regulatory BCells in Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

Regulatory BCells in Systemic Lupus Erythematosus and Its Relation to Atherosclerosis and Disease Activity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03178721
• Other study ID #: breg
• Status: Not yet recruiting
• Phase: N/A
• First received: May 30, 2017
• Last updated: June 5, 2017
• Start date: June 25, 2017
• Est. completion date: July 25, 2018

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Systemic lupus erythematosus , the archetypal multisystem autoimmune disease, presents many diagnostic and management challenges. One such challenge is the excess cardiovascular disease observed in patients with Systemic lupus erythematosus . Coronary heart disease and other manifestations of atherosclerosis continue to be a major cause of death in patients with Systemic lupus erythematosus.Regulatory B-cells have been identified as a negative regulator of the immune system that inhibit pathological immune response by suppressing both uncontrolled protective immune response and damaging autoimmune responses

Description:

Regulatory B cells have been identified as an IL10 producing B cells subsets that are characterized by the expression of CD19 CD24hiCD38hi . Breg cells can inhibit inflammatory responses in autoimmune disease, like Systemic lupus erythematosus, via the production of IL-10 (an antiatherogenic cytokine) which will suppress TNF- α production by monocytes leading to inhibition of T cell-mediated inflammation. Regulatory B have a vital role in immune tolerance and their deficiency resulted in exacerbation of autoimmunity . Evidence suggests Breg in autoimmune disease may be dysfunctional .

In this proposal, We suggest IL-10 production by Breg confers an atheroprotective role. In Systemic lupus erythematosus, Regulatory B ability to control atherosclerosis is reduced therefore, we will test the hypothesis that Regulatory B play an important role in both autoimmunity and accelerated atherosclerosis and dysfunction in Regulatory B from autoimmune disease may or may not result in a reduced ability to control atherosclerosis .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 25, 2018
• Est. primary completion date: June 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Clinical and laboratory Diagnosis of Systemic Lupus disease.

• Must be adult.

Exclusion Criteria:

• Patients with clinical atherosclerotic vascular disease

• pregnancy.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• blood sample
study B regulatory in blood and its correlation with atherosclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Coronary calcium scoring	using Agatston score none (Agatston 0 U) mild (Agatston 1-99 U) moderate(Agatston 100-399 U) high(Agatston >400 U)	1year