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

NCT05045417 | Unknown

• 1 other identifier: Soh-Med-21-09-22
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• SLE disease activity index (SLEDAI)

  • 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

Study Arms (2)

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

control group

30 sex and age matched healthy individuals as a control group

Diagnostic Test: Serum level of IL-17

Interventions

Serum level of IL-17 DIAGNOSTIC_TEST

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)

Cases with SLE; control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Any other autoimmune disease rather than SLE. -
• Systemic diseases
• Malignancy
• pregnancy

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

• Crispin JC, Tsokos GC. IL-17 in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:943254. doi: 10.1155/2010/943254. Epub 2010 Apr 6.

  PMID: 20379379 BACKGROUND

• Garrett-Sinha LA, John S, Gaffen SL. IL-17 and the Th17 lineage in systemic lupus erythematosus. Curr Opin Rheumatol. 2008 Sep;20(5):519-25. doi: 10.1097/BOR.0b013e328304b6b5.

  PMID: 18698171 BACKGROUND

• Su DL, Lu ZM, Shen MN, Li X, Sun LY. Roles of pro- and anti-inflammatory cytokines in the pathogenesis of SLE. J Biomed Biotechnol. 2012;2012:347141. doi: 10.1155/2012/347141. Epub 2012 Feb 15.

  PMID: 22500087 BACKGROUND

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Aya M Ahmed, assistant lecturer

CONTACT

01013325505; aya.ali1@med.sohag.edu.eg

Faten E Mohamed, professor

CONTACT

01066881548

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of rheumatology and rehabilitation sohag university hospitals

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 16, 2021
• Study Start: October 1, 2021
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2022
• Last Updated: September 16, 2021

Record last verified: 2021-09

Locations

EG (1)