Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

Systemic Lupus Erythematosis Clinical Trial

Official title:

Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02756546
• Other study ID #: BC (1016)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 26, 2016
• Last updated: April 27, 2016
• Start date: September 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

This study aims to identify the expression signature of miR-181a, miR-196a and miR-21 in plasma of SLE patients and difference in their expression among groups with different systemic lupus erythematosis disease activity index (SLEDAI) scores.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult systemic lupus erythematosis patients

Exclusion Criteria:

• Patients younger than 18 years, patients with other autoimmune diseases or malignancy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosis

Intervention

Drug:
• Cyclophosphamide

• Hydroxychloroquine

• Hydrocortisone

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MicroRNAs expression level		3 months	No