search
Back to results

Evaluation Of Serum MIF Level in SLE Patients

Primary Purpose

Systemic Lupus Erythematosus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Macrophage migration inhibitory factor
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Systemic Lupus Erythematosus

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    study group

    Arm Description

    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

    Outcomes

    Primary Outcome Measures

    level of Serum Macrophage Migration Inhibitory Factor Level in Systemic Lupus Erythematosus Patients and Its Association with Disease Activity and Severity
    measurement through ELISA

    Secondary Outcome Measures

    Full Information

    First Posted
    November 28, 2021
    Last Updated
    February 13, 2022
    Sponsor
    Assiut University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05253638
    Brief Title
    Evaluation Of Serum MIF Level in SLE Patients
    Official Title
    Evaluation Of Serum MIF Level in SLE Patients and It's Association With Disease Activity and Severity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    February 22, 2022 (Anticipated)
    Primary Completion Date
    December 22, 2022 (Anticipated)
    Study Completion Date
    December 28, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

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

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Systemic Lupus Erythematosus

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Macrophage migration inhibitory factor
    Other Intervention Name(s)
    Macrophage migration inhibitory factor (MIF)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    level of Serum Macrophage Migration Inhibitory Factor Level in Systemic Lupus Erythematosus Patients and Its Association with Disease Activity and Severity
    Description
    measurement through ELISA
    Time Frame
    1 hour

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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).

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Evaluation Of Serum MIF Level in SLE Patients

    We'll reach out to this number within 24 hrs