REALISE
Research type
Research Study
Full title
Experimental medicine studies of brain and peripheral immune mechanisms for sickness behaviours in patients with rheumatoid arthritis
IRAS ID
278617
Contact name
Jonathan Cavanagh
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
2 years, 11 months, 31 days
Research summary
Sickness behaviours (including mood change and fatigue) in the context of immune-mediated inflammatory disorders (IMIDs) such as rheumatoid arthritis (RA) are a major unmet clinical need. Behavioural symptoms have a significant adverse impact on prognosis and treatment outcomes, and they are at the top of the list of patients' concerns. We need to understand the brain and immune mechanisms for sickness behaviour in IMIDs if we are to develop new and more effective treatments in future. We aim to test the mechanistic hypotheses that sickness behaviour is associated with changes in the brain and related to abnormal brain infiltration by circulating monocytes. We will use ultra high-field (7T) magnetic resonance imaging (MRI) and spectroscopy (MRS) to measure brain networks and glutamate biochemistry. We will also use an innovative single photon emission tomography (SPET) technique to measure CNS infiltration by circulating monocytes. These imaging endpoints (plus secondary cognitive-behavioural, clinical and peripheral immune endpoints) will be measured at baseline and 6 weeks later in up to 50 patients with RA, randomised 1:1 to treatment with anti-TNF antibody or placebo infusion.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
21/SW/0126
Date of REC Opinion
8 Nov 2021
REC opinion
Further Information Favourable Opinion