IL17 in Systemic Lupus Erythematosus Patients: Association With Disease Activity and Organ Damage

September 12, 2021 updated by: Aya Mohamed Ali, Sohag University
Many laboratory markers can be measured for assessment of Lupus activity as aberrant manufacturing and imbalance of the cytokines of T-helper cell which already have been implicated within autoimmunity pathogenesis as IL-18 and IL-10 levels are usually elevated in lupus sufferers and correlated with SLEDAI score IL-17 has been linked to immune-mediated organ damage in several autoimmune diseases and recently it has been linked to pathogenesis of a murine model of lupus and human lupus Diverse cytokine abnormalities which common in lupus patients may skew T cells differentiation into IL-17-producing CD4+ and double negative T cells. This could promote the autoimmune process by activation of immune cells &stimulation of proliferation of B-cell and production of antibody

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

140

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

  • Name: Faten E Mohamed, professor
  • Phone Number: 01066881548

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • The study will include 110 patients with SLE :

    • 40 with lupus nephritis
    • 40 with interstitial lung disease
    • 30 SLE patients without internal organ affection)
  • In addition to 30 sex and age matched healthy individuals as a control group

Description

Inclusion Criteria:

  • SLE will be diagnosed according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) classification criteria for SLE
  • Age ≥ 18 years.
  • Patients who are able and willing to give written informed consent

Exclusion Criteria:

-Any other autoimmune disease rather than SLE. -

  • Systemic diseases
  • Malignancy
  • pregnancy

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases with SLE

110 patients with SLE will be divided to :

  • 40 patients with lupus nephritis
  • 40 patients interstitial lung disease
  • 30 SLE patients without internal organ affection)
Diagnostic test: Serum level of IL-17

Measurement of serum level of IL-17 :

  1. To explore the role of IL-17 in systemic lupus erythematosus
  2. To determine the relation between IL-17 and lupus disease activity
  3. To analyze the correlation between IL-17 and internal organ affection (lupus nephritis , interstitial lung disease)
control group
30 sex and age matched healthy individuals as a control group
Diagnostic test: Serum level of IL-17

Measurement of serum level of IL-17 :

  1. To explore the role of IL-17 in systemic lupus erythematosus
  2. To determine the relation between IL-17 and lupus disease activity
  3. To analyze the correlation between IL-17 and internal organ affection (lupus nephritis , interstitial lung disease)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SLE disease activity index (SLEDAI)
Time Frame: 18 Months

• Assessment of the disease activity in the patients will be done by using the SLE disease activity index (SLEDAI). It potentially measures reversible manifestations of the underlying inflammatory disease process. The scale includes24 "weighted" attribute grouped into 9 domains. The final score is the sum of all attributed scores.

  • No activity 0
  • mild activity: 1-5
  • moderate activity: 6- 1 0
  • high activity : 1 1 - 1 9
  • very high > 20
18 Months

Collaborators and Investigators

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

Sponsor

Sohag University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

October 1, 2021

Primary Completion (Anticipated)

April 30, 2022

Study Completion (Anticipated)

April 30, 2022

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

September 12, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

September 16, 2021

Last Update Submitted That Met QC Criteria

September 12, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-09-22

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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