Etanercept in Rheumatoid Arthritis and Vascular Inflammation

Rheumatoid Arthritis Clinical Trial

Official title: Pilot Open-label Study of the Effect of Etanercept on Vascular Inflammation in Patients With Active Rheumatoid Arthritis

Status Terminated

Clinical Trial Summary

The primary goal of this preliminary project is to study the effect of etanercept, a medicine approved by Health Canada for the treatment of rheumatoid arthritis, on the inflammation of certain blood vessels. In particular, the inflammation of the aorta and the carotid arteries will be studied.

This study's goal is to determine if etanercept (that blocks TNF (tissue necrosis factor) alpha) could have an effect on blood vessel inflammation. As well, the information from this study will be used to determine the number of patients to recruit in a future study.

This study will evaluate the effect of etanercept on 10 patients with rheumatoid arthritis at one rheumatology clinic in Montreal. The 10 patients will be recruited at the Montreal Rheumatology Institute (Institut de Rhumatologie de Montréal) and the images of the blood vessels taken at a medical imaging center will be analyzed by the Montreal Heart Institute.

To evaluate vascular inflammation subjects will undergo a PET scan (Positron Emission Tomography).

Clinical Trial Description

This study is a 16 week, single center, open label trial, to study the effect of etanercept on vascular inflammation of the ascending aorta and carotid arteries in patients with rheumatoid arthritis (RA).

Patients with active RA already receiving methotrexate for at least 3 months will receive etanercept for 16 weeks. Etanercept will be administered sub-cutaneously using the dose approved in the Canadian product monograph for RA (50 mg every week). Patients will continue methotrexate at a stable dose during the study unless a dose reduction or cessation is required as judged necessary by the study investigator. Positron Emission Tomography (PET) Scan will be performed at baseline and after16 weeks of study treatment with etanercept. At the end of the study, all PET Scan images will be analyzed in a blinded manner by the Montreal Heart Institute core laboratory.

Safety will be assessed using adverse events collection and laboratory hematology and chemistry analysis (screening and Week 4) and pregnancy test. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis
• Vascular Inflammation

• NCT number: NCT02109289
• Study type: Interventional
• Source: Innovaderm Research Inc.
• Status: Terminated
• Phase: Phase 4
• Start date: April 2014
• Completion date: November 2016