Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-01-01 @ 10:38 AM
Study NCT ID:
NCT03719469
Status:
COMPLETED
Last Update Posted:
2018-10-26
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis
Sponsor:
King Saud University
Organization:
Study Overview
Official Title:
Circulating microRNAs Expression as Predictors of Clinical Response in Rheumatoid Arthritis Patients Treated With Green Tea
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The correlation of circulating serum miR-125ba and miR-146a expression and clinical response to green tea therapy were analysed in RA patients.Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores. Whereas , a decrease of 1.2 points or above in DAS28 scores at 24 weeks of treatment compared with baseline was defined as clinical response according to the EULAR response criteria.A ready-made solutions containing the primers and probes for human miR-146a and miR-125ba (Applied Biosystems, Foster City, CA) and real-time RT-PCR was estimated using an ABI 7300 system (Applied Bio systems).
Detailed Description:
1. participants: A total of 100 subjects (aged 18-65 years) who were diagnosed as RA with moderate to severe activity at the division of rheumatology and clinical immunology at Mansoura University were evaluated in this study.
2. patients were evaluated for therapeutic response at baseline and 12, and 24 weeks of green tea therapy. All patients with RA were subjected for estimation of ESR, CRP, disease activity score in 28 joints (DAS28), patient's global assessment (PGA), and health assessment questionnaire damage index (HAQ-DI) at each visits (0 week, 12 weeks, and 24 weeks).
3. Pain intensity was assessed by using a standard VAS of 100 mm previously validated to chronic and acute pains.
4. Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores.
5. human miR-146a and miR-125ba were isolated and subjected to RT-PCR analysis
2. patients were evaluated for therapeutic response at baseline and 12, and 24 weeks of green tea therapy. All patients with RA were subjected for estimation of ESR, CRP, disease activity score in 28 joints (DAS28), patient's global assessment (PGA), and health assessment questionnaire damage index (HAQ-DI) at each visits (0 week, 12 weeks, and 24 weeks).
3. Pain intensity was assessed by using a standard VAS of 100 mm previously validated to chronic and acute pains.
4. Clinical response to green tea therapy for 24 weeks was calculated from DAS28 scores.
5. human miR-146a and miR-125ba were isolated and subjected to RT-PCR analysis
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: