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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05045417
• Other study ID #: Soh-Med-21-09-22
• Status: Not yet recruiting
• Start date: October 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: September 2021
• Source: Sohag University
• Contact: Aya M Ahmed, assistant lecturer
• Phone: 01013325505
• Email: aya.ali1[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Diagnostic Test:
• Serum level of IL-17
Measurement of serum level of IL-17 : To explore the role of IL-17 in systemic lupus erythematosus To determine the relation between IL-17 and lupus disease activity To analyze the correlation between IL-17 and internal organ affection (lupus nephritis , interstitial lung disease)

Locations

Country	Name	City	State
Egypt	Sohag University Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Crispín JC, Tsokos GC. IL-17 in systemic lupus erythematosus. J Biomed Biotechnol. 2010;2010:943254. doi: 10.1155/2010/943254. Epub 2010 Apr 6. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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