Evaluation Of Serum MIF Level in SLE Patients

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05253638
Collaborator
(none)
60
1
10.2

Study Details

Study Description

Brief Summary

Systemic lupus erythematosis (SLE) is a chronic autoimmune disease characterized by production of autoantibodies and the deposition of immune complexes, affecting a wide range of organs. The clinical onset of SLE derives from the interaction between genetic predisposition and environmental, immunological and hormonal factors, with a strong predilection for women of childbearing age.

SLE is usually diagnosed in young women in the third decade of life and represents the leading cause of systemic disease with secondary kidney involvement. Lupus nephritis (LN) occurs in ~50% of patients with SLE and is the most common, but not the only, cause of kidney injury in SLE. LN typically develops early in the disease course, generally within the first 6 to 36 months, and may be present at initial diagnosis.

Macrophage migration inhibitory factor (MIF) is a pleiotropic inflammatory cytokine with regulatory roles in innate and adaptive immunity and is implicated in the pathogenesis of autoimmune diseases including SLE.

MIF actively participates in multiple stages of the inflammatory response, acting on cells directly and/or potentiating the effects exerted by other stimuli. MIF overcomes the inhibitory effects of glucocorticoids on TNF alpha, IL-1 beta, IL-6, and IL-8 production.

MIF is implicated in the pathogenesis of other autoimmune diseases including rheumatoid arthritis (RA), type 1 diabetes, multiple sclerosis and Guillain Barré syndrome.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Macrophage migration inhibitory factor
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Evaluation Of Serum MIF Level in SLE Patients and It's Association With Disease Activity and Severity
Anticipated Study Start Date :
Feb 22, 2022
Anticipated Primary Completion Date :
Dec 22, 2022
Anticipated Study Completion Date :
Dec 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: study group

Patients will be recruited from the Rheumatology, Rehabilitation Department from The in patient and out patient clinic of Assiut University Hospitals with an informed consent will be obtained from all patients. Adult SLE patients >18 who fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

Diagnostic Test: Macrophage migration inhibitory factor
Assessment of disease activity: This assessment will be performed using the systemic lupus erythematosus disease activity index (SLEDAI). The SLEDAI is an index designed to assess disease activity in the preceding 10 days, with 24 weighted clinical and laboratory variables corresponding to 9 different organs/systems. The SLEDAI score ranges from 0 to 105 Renal activity will be evaluated with the renal-SLEDAI (rSLEDAI), which represents the sum of the renal items of the SLEDAI. The rSLEDAI includes the following items: proteinuria, pyuria, erythrocyturia, and urine casts; each one is scored with 0 meaning absence or 4 points meaning presence; therefore, the maximum rSLEDAI is 16
Other Names:
  • Macrophage migration inhibitory factor (MIF)
  • Outcome Measures

    Primary Outcome Measures

    1. level of Serum Macrophage Migration Inhibitory Factor Level in Systemic Lupus Erythematosus Patients and Its Association with Disease Activity and Severity [1 hour]

      measurement through ELISA

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Adult SLE patients >18 years

    • fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

    Exclusion Criteria:
    • Patients with overlap syndrome, pregnancy, active infection, diseases other than SLE that might produce abnormal proteinuria.

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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Manal Kamal, Principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05253638
    Other Study ID Numbers:
    • MIF S
    First Posted:
    Feb 24, 2022
    Last Update Posted:
    Feb 24, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 24, 2022