Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy

Study Overview
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Brief Summary
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The aim of this study is to analyze the variation of adiponectinemia and its molecular forms in RA patients receiving tocilizumab therapy.

Detailed Description
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Rheumatoid arthritis (RA) is a chronic inflammatory disease associated with cardiovascular morbidity. Tocilizumab (TCZ), a monoclonal antibody against the interleukin-6 receptor is an effective new biotherapy for the treatment of RA. This treatment is associated with increased LDL and HDL-cholesterol lipid parameters. Adipokines are adipose tissue-specific secreted molecules, which have many functions such as regulation of appetite, blood glucose or immune response. Among the adipokines, adiponectin exerts beneficial effects on the cardiovascular system. Patients with RA also exhibit body composition changes, including an increase in abdominal visceral fat. The impact of tocilizumab therapy in RA patients on adipokines and body composition is not known. This project aims to explore the evolution of circulating adiponectin and other adipokines during tocilizumab therapy in RA. Body composition and its variations under tocilizumab therapy will also be analyzed.

Official Title
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Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy

Conditions
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Arthritis, Rheumatoid

Intervention / Treatment
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* Drug: Tocilizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a diagnosis of RA and requiring Tocilizumab therapy Subject has provided written informed consent Exclusion Criteria: Corticosteroid therapy (10 mg/day of prednisone or equivalent) Pregnant or lactating women Uncontrolled type 1 or type 2 diabetes Uncontrolled dyslipidemia Elevated transaminases (> three times higher than the normal range) History of diverticulitis or intestinal perforation Tocilizumab contraindications: Severe or active infections, Hypersensitivity to the active substance or to any of the excipients

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adiponectin evaluation<br>Patients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab | Drug: Tocilizumab<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum total adiponectin (ng/ml) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum high-molecular weight adiponectin (ng/ml) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adipokines, Tocilizumab