Circulating microRNAs as Novel Prognosis Biomarkers for Rheumatoid Arthritis

NCT03719469 | Completed

• 1 other identifier: RRC-2015-058
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Rh Disease

Outcome Measures

Primary Outcomes (1)

• Functional status

  It will be assessed using disease activity score -28 (DAS28) and pre-validated health assessment questionnaire damage index (HAQ-DI). For DAS28 score, the number of swelling joints count (SJC) (0-28) and tender joints count (TJC) (0-28) in all patients were examined and DAS28 scores were calculated . DAS28 values \> 2.6 and ≤ 3.2 was considered as low RA disease activity, values \> 3.2 and ≤ 5.1 was considered as moderate disease activity and those \> 5.1 was considered as high disease activity. In case of HAQ-DI, score calculation involves answering of eight domains(dressing, rising, eating, walking, hygiene, grip, reach and usual activities) with four point likert scale . SDAI values \> 3.3 and ≤11 was considered as low RA disease activity, values \> 11 and ≤ 26 was considered as moderate disease activity and those \> 26 was considered as high disease activity

  change from baseline functional status at 24 weeks

Secondary Outcomes (2)

• Pain intensity

  change from baseline functional status at 24 weeks

• Abnormal cell physiology and the parthenogenesis of Rheumatoid arthritis (RA)

  change from baseline functional status at 24 weeks

Study Arms (2)

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.

Dietary Supplement: Green tea group

control group

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

Interventions

Green tea group DIETARY_SUPPLEMENT

Green tea group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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, 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Saud University: lead

Related Publications (1)

• 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.

  PMID: 31282597 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

For each subject, total RNA was extracted from serum samples using the TRIzol LS reagent (Invitrogen, Carlsbad, CA), and subjected to RT-PCR analysis. 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) (Mazloom et al.,2015).

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical Professor

Study Record Dates

• First Submitted: September 6, 2018
• First Posted: October 25, 2018
• Study Start: January 20, 2015
• Primary Completion: January 20, 2015
• Study Completion: September 20, 2015
• Last Updated: October 26, 2018

Record last verified: 2018-10