Effect of Monoclonal Anti-IL6 Antibody (Tocilizumab) on the Cardiovascular Risk in Patients With Rheumatoid Arthritis (TOCRIVAR)
The purpose of this study is to determine whether tocilizumab changes the cardiovascular risk factors on patients with arthritis rheumatoid.
Study hypothesis: the IL-6 contributes to increase the cardiovascular risk factors of patients with rheumatoid arthritis because it produces systemic effects as increasing weight and atherogenic body fat, changing energy homeostasis and inducing the adipokines production and the insulin resistence.
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||Effect of Monoclonal Anti-IL6 Antibody (Tocilizumab) on the Cardiovascular Risk in Patients With Rheumatoid Arthritis|
- Framingham Point Scores [ Time Frame: Baseline and 52 weeks ]Proportion of changes in Framingham Point Scores
- Liver enzymes [ Time Frame: Baseline, 12, 24 and 52 weeks ]Number of patients with liver enzymes elevated.
- Lipoprotein levels [ Time Frame: Baseline, 12, 24 and 52 weeks ]Number of patients with elevated lipoprotein levels
- DAS28 score [ Time Frame: Baseline and 52 week ]Variation in DAS28 score after tocilizumab
- Number of patients with Adverse Drug Reactions [ Time Frame: up to 52 weeks ]Number of patients with Adverse Drug Reactions as a measure of safety
- Insulinemia [ Time Frame: Baseline and 52 week ]Change in insulinemia 52 weeks later.
- Proportion of brachial artery vasodilation [ Time Frame: Baseline, 24 and 52 weeks ]To evaluate the endothelial responses to ischemia and vasodilatation by ecography
- cytokines, adipokines and adhesion molecules levels [ Time Frame: Baseline and 52 week ]To evaluate changes in cytokines, adipokines and adhesion molecules
|Study Start Date:||December 2011|
|Estimated Study Completion Date:||March 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
All the patients are treated with tocilizumab before inclusion. The doses, frequency and duration are in acordance with the Summary of Characteristics of the Product authorised by EMA.
Usually 8mg/kg (not minor than 480 mg), once each 4 weeks.
Other: Braquial ecography
At the moment of the ecography, the clinician evaluates the endothelial responses via applying braquial ischemia and administering sublingual nitroglicerin spray to evaluate vasodilation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752335
|Hospital Universitario de Canarias|
|La Laguna, Santa Cruz de Tenerife, Spain, 38320|
|Principal Investigator:||Federico Díaz González, MD, PhD||Hospital Universitario de Canarias|