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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02843789

Acronym

ADIPRAT

Enrollment

109

Registered

2016-07-26

Start date

2013-03-31

Completion date

2017-11-30

Last updated

2018-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Rheumatoid

Keywords

Adipokines, Tocilizumab

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.

Interventions

DRUGTocilizumab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Serum total adiponectin (ng/ml)	12 months

Secondary

Measure	Time frame
Serum high-molecular weight adiponectin (ng/ml)	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026