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

Phase 4

Completed

• Conditions: Arthritis, Rheumatoid
• Interventions: Drug: Tocilizumab

• Registration Number: NCT02843789
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2013-03
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-21
• Study First Posted: 2016-07-26
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-09
• Last Update Posted: 2018-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adiponectin evaluation	Tocilizumab	Patients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab

Primary Outcome Measures

Name	Time	Method
Serum total adiponectin (ng/ml)	12 months

Secondary Outcome Measures

Name	Time	Method
Serum high-molecular weight adiponectin (ng/ml)	12 months

Trial Locations

Locations (1)

University Hospital; 🇫🇷 Besançon, France