Clinical trial NCT02843789: Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
Official title: Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arthritis, Rheumatoid
Keywords: Adipokines
Tocilizumab
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-07-26
Enrollment: 109
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Serum total adiponectin (ng/ml)
timeFrame: 12 months
Secondary outcomes:
measure: Serum high-molecular weight adiponectin (ng/ml)
timeFrame: 12 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: University Hospital
Study officials:
affiliation: University Hospital, Besançon, France
name: Eric Toussirot, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Toussirot E, Marotte H, Mulleman D, Cormier G, Coury F, Gaudin P, Dernis E, Bonnet C, Damade R, Grauer JL, Abdesselam TA, Guillibert-Karras C, Liote F, Hilliquin P, Sacchi A, Wendling D, Le Goff B, Puyraveau M, Dumoulin G. Increased high molecular weight adiponectin and lean mass during tocilizumab treatment in patients with rheumatoid arthritis: a 12-month multicentre study. Arthritis Res Ther. 2020 Sep 29;22(1):224. doi: 10.1186/s13075-020-02297-7.