Tocilizumab Effect on microRNA Expression and Adipokine Levels in Rheumatoid Arthritis Patients

NCT03149796 | Completed

• 1 other identifier: CMC-11-0018-CTIL
• Study Type: observational
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The investigators propose to identify changes in cytokines like adipocytokines and microRNA (miR) expression (for example miR-9, miR-16, miR-125, miR-132, miR-146a, miR-150, miR-155, miR-181 and miR-223) in peripheral blood leukocytes and in serum samples obtained from rheumatoid arthritis (RA) patients before and after tocilizumab treatment. The results obtained will be compared to gender- and age-matched healthy controls, and will help the investigators define one or more miRNAs as biomarkers for treatment effectiveness. Methods The investigators will obtain blood samples from 60 RA patients treated with tocilizumab, according to the local clinical guidelines. Blood samples will be collected before treatment, as well as one and four months following tocilizumab treatment. The blood samples will initially undergo microarray analysis and then the results will be confirmed for specific miRNAs by quantitative real-time PCR (qPCR). The serum level of the tested cytokines, like adipokines, will be measured using ELISA methods. The changes in cytokines level and miRNAs expression, either up-regulation or down-regulation, during tocilizumab therapy will be correlated to the severity of the disease and to specific demographic and medical data. The results obtained will be compared to 60 healthy controls gender- and age-matched

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• expression of biomarkers like adipocytokines and miRNAs

  expression of biomarkers like adipocytokines and miRNAs in peripheral blood leukocytes and in serum samples obtained from RA patients. Candidate miRNAs that are likely to be quantitated are for example miR-9, 16, 125, 132, 146a, 150, 155, 181 and, 223

  four months

Study Arms (2)

RA patients

designated to be treated with tocilizumab and followed in rheumatology clinics. Laboratory blood tests will be collected and analyzed

Other: laboratory blood tests

healthy controls

control Laboratory blood tests will be collected and analyzed

Other: laboratory blood tests

Interventions

laboratory blood tests OTHER

Serum concentrations of leptin, adiponectin, resistin, interleukin-6 and high sensitivity C reactive protein were measured by ELISA in both study groups

RA patients; healthy controls

Eligibility Criteria

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

Study Population

RA patients treated with tocilizumab, according to the local clinical guidelines

You may qualify if:

• Patients fulfilling the 2010 Rheumatoid Arthritis Classification criteria.
• Patients designated to tocilizumab treatment
• Age above 18 years old
• Signed informed concern
• Ability to read and write in Hebrew

You may not qualify if:

• Patients with other rheumatic diseases
• Patients with other inflammatory diseases
• Patients with malignancies

Sponsors & Collaborators

• Carmel Medical Center: lead

Related Publications (22)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

periferal blood and serum

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of rheumatology department

Study Record Dates

• First Submitted: May 10, 2017
• First Posted: May 11, 2017
• Study Start: March 23, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 16, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share