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Trial record 32 of 703 for:    lupus AND Lupus Erythematosus, Systemic

Regulatory BCells in Systemic Lupus Erythematosus

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ClinicalTrials.gov Identifier: NCT03178721
Recruitment Status : Not yet recruiting
First Posted : June 7, 2017
Last Update Posted : June 7, 2017
Sponsor:
Information provided by (Responsible Party):
Eman Mohamed Shawky, Assiut University

Brief 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

Condition or disease Intervention/treatment
Systemic Lupus Erythematosus Diagnostic Test: blood sample

Detailed 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 .


Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Case-Crossover
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Regulatory BCells in Systemic Lupus Erythematosus and Its Relation to Atherosclerosis and Disease Activity
Estimated Study Start Date : June 25, 2017
Estimated Primary Completion Date : June 25, 2018
Estimated Study Completion Date : July 25, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
1
Systemic lupus erythematosus with atherosclerosis
Diagnostic Test: blood sample
study B regulatory in blood and its correlation with atherosclerosis
Other Name: Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonography

2
Systemic lupus erythematosus without atherosclerosis
Diagnostic Test: blood sample
study B regulatory in blood and its correlation with atherosclerosis
Other Name: Coronary calcium scoring: all participants will be scanned using a 64-slice CT scanner and Carotid intimae media thickness (CIMT): Carotid artery ultrasonography




Primary Outcome Measures :
  1. Coronary calcium scoring [ Time Frame: 1year ]
    using Agatston score none (Agatston 0 U) mild (Agatston 1-99 U) moderate(Agatston 100-399 U) high(Agatston >400 U)


Biospecimen Retention:   Samples Without DNA
1- 5ml fresh human peripheral whole blood was layered over a ficoll density gradient to isolate PBMCs. Breg cells will be sorted by fluorescently labelling PBMCs to identify Breg cells Quantification of the percentage of specific phenotype CD19+ CD38hi CD24hi of B-reg by using flow cytometry.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
adult patients with systemic lupus erythematosus
Criteria

Inclusion Criteria:

  • Clinical and laboratory Diagnosis of Systemic Lupus disease.
  • Must be adult.

Exclusion Criteria:

  • Patients with clinical atherosclerotic vascular disease
  • pregnancy.

Responsible Party: Eman Mohamed Shawky, principle investegator, Assiut University
ClinicalTrials.gov Identifier: NCT03178721     History of Changes
Other Study ID Numbers: breg
First Posted: June 7, 2017    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases