Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis

NCT ID: NCT03719469

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-20
• Study Completion Date: 2015-09-20

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

Conditions

Rh Disease

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Study Groups

Green tea group

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,After starting green tea supplement (4 to 6 cups/day; 60 to 125 mg catechins), patients were evaluated for therapeutic response at baseline and 12, and 24 weeks.

Green tea group

Intervention Type: DIETARY_SUPPLEMENT

control group

fifty healthy normal subjects were included in this study as controls.

No interventions assigned to this group

Interventions

Green tea group

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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, between 20 January/2015 and 20 September 2015 were recruited in this prospective study.
• According to the diagnostic criteria of the American College of Rheumatology (Arnett et al., 1988), all patients classified as showing established RA for more than 8 years.
• Only patients who had higher scores of DAS28-ESR, RA biomarkers, and established radiographic analysis, and were diagnosed with RA according to the 2010ACR/ EULAR classification criteria were included in this study.

Exclusion Criteria

• Patients who received non-steroidal anti-inflammatory drugs, oral glucocorticoids, had a history of severe deformation of joint, pregnant or lactating women were excluded from this study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

King Saud University

OTHER

Sponsor Role: lead

Responsible Party

Sami Gabr

clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Al-Rawaf HA, Alghadir AH, Gabr SA. MicroRNAs as Biomarkers of Pain Intensity in Patients With Chronic Fatigue Syndrome. Pain Pract. 2019 Nov;19(8):848-860. doi: 10.1111/papr.12817. Epub 2019 Aug 30.

Reference Type: DERIVED

PMID: 31282597 (View on PubMed)

Other Identifiers

RRC-2015-058

Identifier Type: -

Identifier Source: org_study_id