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

Centre Hospitalier Universitaire de Besancon109 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

109

Conditions

Arthritis, Rheumatoid

Interventions

TocilizumabDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital

Besançon, France

Outcomes

Primary Outcomes

Serum total adiponectin (ng/ml)

Time frame: 12 months

Secondary Outcomes

Serum high-molecular weight adiponectin (ng/ml)

Time frame: 12 months

Data from ClinicalTrials.gov

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