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NCT02843789 Clinical Trial

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

Arthritis, Rheumatoid Clinical Trial

— ADIPRAT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02843789
Other study ID # P/2011/118
Secondary ID
Status Completed
Phase Phase 4
First received July 19, 2016
Last updated February 9, 2018
Start date March 2013
Est. completion date November 2017

Study information
Verified date February 2018
Source Centre Hospitalier Universitaire de Besancon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 109
Est. completion date November 2017
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tocilizumab

Locations
Country Name City State
France University Hospital Besançon

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serum total adiponectin (ng/ml) 12 months
Secondary Serum high-molecular weight adiponectin (ng/ml) 12 months
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