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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

109 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-11-30

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.

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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.

Conditions

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Arthritis, Rheumatoid

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Adiponectin evaluation

Patients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab

Group Type EXPERIMENTAL

Tocilizumab

Intervention Type DRUG

Interventions

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Tocilizumab

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No