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
About this trial
This is an interventional diagnostic trial for Systemic Lupus Erythematosus
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).
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
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
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Evaluation Of Serum MIF Level in SLE Patients
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