Evolution of Adipokines and Body Composition in Rheumatoid Arthritis Patients Receiving Tocilizumab Therapy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 109
- Locations
- 1
- Primary Endpoint
- Serum total adiponectin (ng/ml)
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Adiponectin evaluation
Patients evaluated for serum adiponectin level and for body composition before each infusion of Tocilizumab
Intervention: Tocilizumab (Drug)
Outcomes
Primary Outcomes
Serum total adiponectin (ng/ml)
Time Frame: 12 months
Secondary Outcomes
- Serum high-molecular weight adiponectin (ng/ml)(12 months)