CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 80 enrolled
Drug / intervention
laboratory blood testsother
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03149796
NCT03149796N/ACompleted

The Effect of Tocilizumab (Anti-interleukin-6) Treatment on microRNA Expression and Adipokine Levels in Rheumatoid Arthritis Patients

Carmel Medical Center·observational·Posted May 11, 2017·Updated May 16, 2017

In Brief

An observational study evaluating laboratory blood tests for Rheumatoid Arthritis. Completed, enrolled 80 participants.

Detailed 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

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMay 11, 2017
Enrollment StartMar 23, 2011
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 9.1 years ago

Interventions

laboratory blood testsother

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