Back to resultsCirculating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis
Primary Purpose
Systemic Lupus Erythematosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cyclophosphamide
Hydroxychloroquine
Hydrocortisone
Sponsored by
About this trial
This is an interventional diagnostic trial for Systemic Lupus Erythematosis
Eligibility Criteria
Inclusion Criteria:
- Adult systemic lupus erythematosis patients
Exclusion Criteria:
- Patients younger than 18 years, patients with other autoimmune diseases or malignancy.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Control
Patients
Arm Description
Healthy volunteers
SLE patients further divided into mild and severe patients
Outcomes
Primary Outcome Measures
MicroRNAs expression level
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02756546
Brief Title
Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis
Official Title
Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Healthy volunteers
Arm Title
Patients
Arm Type
Active Comparator
Arm Description
SLE patients further divided into mild and severe patients
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
Hydroxychloroquine
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Primary Outcome Measure Information:
Title
MicroRNAs expression level
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult systemic lupus erythematosis patients
Exclusion Criteria:
Patients younger than 18 years, patients with other autoimmune diseases or malignancy.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Publication
Learn more about this trial
Circulating MicroRNAs in Understanding Pathogenesis of Systemic Lupus Erythematosis
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