BAROQUE
Research type
Research Study
Full title
A Phase IIb, Double-Blind, Placebo-Controlled, Dose-Adaptive, Study of the Efficacy and Safety of GSK3196165 in Combination with Methotrexate Therapy, in Subjects with Active Moderate-Severe Rheumatoid Arthritis Despite Treatment with Methotrexate.
IRAS ID
179662
Contact name
HIRA SAJJAD
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Eudract number
2014-003453-34
Duration of Study in the UK
1 years, 7 months, 18 days
Research summary
Rheumatoid arthritis (RA) is an autoimmune condition, which means it is caused by the body’s immune system attacking itself. In particular, the immune system starts attacking the tissue surrounding the joints, causing joints to become sore and inflamed. It is thought that this inflammation is caused by substances released by certain types of cells in and around the joints. One of these substances is called GM-CSF.
Disease-modifying antirheumatic drugs (DMARDs) are the cornerstone of RA treatment throughout all stages of disease, and have been demonstrated to maintain or improve physical function and slow the damage seen on the joint x-ray. This wide class of drugs includes conventional DMARDs, of which methotrexate (MTX) is the gold standard, and biological DMARDs which target cytokines. Cytokines are proteins that are produced by cells. Cytokines interact with cells of the immune system in order to regulate the body's response to disease and infection.
However, a substantial proportion of patients either fail to respond, or have inadequate response, to currently available RA therapies. Therefore, there is still a medical need for more effective treatments for RA with alternative mechanisms of action.
GSK3196165 is a type of medicine called a monoclonal antibody (sometimes known as a “biologic” drug). Normally, the immune system makes antibodies that attack bacteria and viruses, helping to fight infection. Monoclonal antibodies are different – they are made in a laboratory and have been purposefully designed to target specific cells or substances in the human body. In this case, GSK3196165 has been designed to specifically target and block the action of GM-CSF in the body. Since GM-CSF is thought to be one of the causes of inflamed joints in RA, by blocking the action of GM-CSF, GSK3196165 may therefore reduce inflammation and improve the signs and symptoms of RA.
The purpose of this study is to assess how well GSK3196165 works in treating RA when added to methotrexate, to identify the most effective dose(s) of GSK3196165, and also to test the safety of this treatment.
This is a randomised study meaning participants have an equal chance of receiving one of five doses of GSK3196165 or placebo.About 210 people in about 20 countries in Europe, South America, Canada and South Africa will take part in this study. This study is being funded by GlaxoSmithKline.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
15/EM/0306
Date of REC Opinion
24 Aug 2015
REC opinion
Further Information Favourable Opinion