NCT05253638

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2022

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2022

Completed
Last Updated

February 24, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

November 28, 2021

Last Update Submit

February 13, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

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

    measurement through ELISA

    1 hour

Study Arms (1)

study group

EXPERIMENTAL

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

Interventions

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

Also known as: Macrophage migration inhibitory factor (MIF)
study group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adult SLE patients \>18 years
  • fulfilled the 2012 systemic lupus international collaborating clinics (SLICC) criteria

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 28, 2021

First Posted

February 24, 2022

Study Start

February 22, 2022

Primary Completion

December 22, 2022

Study Completion

December 28, 2022

Last Updated

February 24, 2022

Record last verified: 2022-02