Association Between Neuropathy and Some Autoantibodies in Systemic Lupus Erythematosus (SLE) Patients

September 23, 2024 updated by: Marina Asaad Fahmy Sedhom, Assiut University

Association Between Neuropathy and Some Autoantibodies in Systemic Lupus Erythematosus (SLE) Patients With Lupus Nephritis in Assiut University Hospital

  1. Frequency of peripheral neuropathy associated with lupus nephritis
  2. Sensitivity and specificity of some biomarkers used in diagnosis and follow up of SLE with lupus nephritis and peripheral neuropathy

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic, inflammatory,autoimmune disease that is characterized by multisystemic involvement with diverse clinical presentation .

Peripheral neuropathy is a well-documented clinical manifestation of systemic lupus erythematosus (SLE) , with a prevalence rate ranging from 2% to 27.8% . Several lines of evidence link the risk of neuropathy with the antiphospholipid antibody and rheumatoid factor , as well as neuropsychiatric lupus with anti-Ro . Some evidence links anti-ganglioside antibodies with neuropathy , but other studies do not . Peripheral neuropathy may be slowly progressive or acutely devastating . Lupus nephritis (LN), a more definite and specific subgroup of lupus, is a major cause of morbidity and mortality in SLE and can affect up to 60% of SLE patients. Furthermore, the presence of peripheral neuropathy in LN patients may be relevant for improving their lives . Such complex situation poses a therapeutic challenge. The clinical presentation of PN relies upon the diameter of the affected nerve, the sort of demyelinating or axonal lesions, and their acute or chronic occurrence . Routine nerve conduction studies just mirror the activity of the fast conducting myelinated A nerve fibers, which are physiologically irrelevant to pain. Hence, quantitative sensory testing can evaluate small nerve fiber function The pathogenesis of SLE-related neuropathy is obscure, and the few pathological studies of the peripheral nerves in SLE have revealed axonal degeneration, inflammatory changes, and vasculitis .

The major inflammatory mediators released from immune cells act on sensory neurons, inducing peripheral sensitization and hyperalgesic phenomena. In addition, after damage, this natural inflammatory response could encourage the pathogenetic activity of antineural autoantibodies, in addition to ischemic vascular mechanism, by vasa nervorum vascularitis or by microthrombi linked to antiphospholipid antibodies.

The other legitimate mechanisms are immunologic cause by a direct aggression by antibodies, entraining obliteration of the peripheral nerve component.

Furthermore, the PN has not been well prescribed in SLE in terms of onset, severity, clinical associations, and electrophysiological characteristics.. Therefore, we are going to characterize PN in SLE with respect to the patient's clinical lupus properties, serologic markers, disease activity, and electrophysiological data

Study Type

Observational

Enrollment (Estimated)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Study tools (in detail, e.g., lab methods, instruments, steps, chemicals, ):patients demographics including )age ,sex , residence , occupation,age at time of diagnosis) Full history and examination

Laboratory data & Investigations

  1. CBC
  2. Kidney function tests
  3. ESR
  4. CRP
  5. urine analysis
  6. screening for (HBv- HcV-HIV)
  7. Autoantibodies: ANA , Anti- ds DNA
  8. Rheumatoid factor
  9. neuromuscular ultrasound 10 - nerve conduction

Description

Inclusion Criteria:

  • 1. Female patients

    2. Age ≥ 18 years

    3. Patients diagnosed as SLE and lupus nephritis as clinical, laboratory investigations and renal biopsy for indicated cases 4. Anti phospholipid antibodies (IgG & IgM) 5.Associated vasculitis ( cANCA & pANCA ) 6.Active - inactive classes of SLE 7.CKD stage I & IV not on dialysis

Exclusion Criteria:

  • 1.history of viral hepatitis B or C 2.A history of malignancy (excluding basal cell carcinoma) 3.pulse therapy 4.chronic kidney disease (CKD) stage 5 or hemodialysis 5.SLE not associated with renal affect

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Inactive stage
patients diagnosed as SLE and lupus nephritis (inactive stage)
Active stage
patients diagnosed as SLE and lupus nephritis (active stage)
Control
patients control group not SLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nephropathy and autoantibodies
Time Frame: through study completion, an average of 1 year]]
1- Relation between neuropathy and autoantibodies in lupus nephritis
through study completion, an average of 1 year]]
Prepherial nephropathy and systemic lupus
Time Frame: through study completion, an average of 1 year]
Evaluate the frequency and severity of symptoms of peripheral neuropathy among patients with lupus nephritis
through study completion, an average of 1 year]
Electrophysiology
Time Frame: through study completion, an average of 1 year]]
Study electrophysiological properties of peripheral neuropathy and their relation to disease activity
through study completion, an average of 1 year]]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 23, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

September 24, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nephropathy and systemic lupus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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