NCT02756546

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 29, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

April 26, 2016

Last Update Submit

April 27, 2016

Conditions

Systemic Lupus Erythematosis

Outcome Measures

Primary Outcomes (1)

  • MicroRNAs expression level

    3 months

Study Arms (2)

Control

NO INTERVENTION

Healthy volunteers

Patients

ACTIVE COMPARATOR

SLE patients further divided into mild and severe patients

Drug: CyclophosphamideDrug: HydroxychloroquineDrug: Hydrocortisone

Interventions

CyclophosphamideDRUG
Patients
HydroxychloroquineDRUG
Patients
HydrocortisoneDRUG
Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult systemic lupus erythematosis patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CyclophosphamideHydroxychloroquineHydrocortisone

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teaching Assistant at faculty of Pharmacy Cairo University

Study Record Dates

First Submitted

April 26, 2016

First Posted

April 29, 2016

Study Start

September 1, 2014

Primary Completion

September 1, 2015

Study Completion

December 1, 2015

Last Updated

April 29, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will share

Publication