Evaluation Of Serum MIF Level in SLE Patients

NCT ID: NCT05253638

Last Updated: 2022-02-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2022-12-28

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.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Macrophage migration inhibitory factor

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Macrophage migration inhibitory factor (MIF)

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Manal Kamal

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

MIF S

Identifier Type: -

Identifier Source: org_study_id