TOCRA
Research type
Research Study
Full title
Prospective Randomised Double-Blind Placebo Controlled Study Assessing the Efficacy of Tocilizumab with Synovial Analysis in Patients with Rheumatoid Arthritis
IRAS ID
3005
Sponsor organisation
University of Leeds
Eudract number
2008-003011-12
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
N/A
Research summary
The purpose of the study is to investigate Tocilizumab, an experimental new drug being studied for treating patients with rheumatoid arthritis. Tocilizumab is an antibody (a protein produced by specific cells in the immune system) that has been designed to block the action of IL-6, a protein involved in many inflammatory pathways linked to rheumatoid arthritis.This study is being carried out to see if Tocilizumab given together with methotrexate can reduce the symptoms of rheumatoid arthritis and prevent damage to the joints from rheumatoid arthritis. The primary aim of this study is to assess changes in synovial tissue (the tissue that surrounds and protects the joints) in an attempt to find out the way Tocilizumab works. We will do this by measuring the changes through different imaging techniques (MRI, Bone density scans, ultrasound scans and x-rays). We will perform blood tests that will allow us to check on the safety of the drug and on any physiological changes that may have resulted from tocilizumab use. We will also take biopsies of the synovial tissue in the knee.Patient participation in the trial lasts for a 12 months. For the first four months, half of the patients will receive active drug and the other half a placebo (a substance that looks the drug but has no active properties). Patients will be assigned to drug or placebo by chance (like flipping a coin). However, for the majority of the study period, the last 8 months, ALL patients will receive active drug.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
08/H1307/119
Date of REC Opinion
27 Feb 2009
REC opinion
Further Information Favourable Opinion