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Completed

NCT Number: NCT02843789

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital

Besançon, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Drug

Primary outcomes

  1. Serum total adiponectin (ng/ml)

    Time frame: 12 months

Secondary outcomes

  1. Serum high-molecular weight adiponectin (ng/ml)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: ADIPRAT

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2016
Registry last updated
Feb 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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