Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE

NCT05090124 NA COMPLETED

The rationale for this study is to use immune molecule-specific drug treatment to leverage a mechanistic understanding of the brain changes that drive sickness behaviour. This will combine current therapy with innovative neuroimaging technologies to obtain data in humans that has hitherto only been available in animal studies. Data supporting the role of inflammatory molecules in sickness behaviours and other cognitive disorders are increasingly compelling. A putative mechanism linking inflammatory proteins to sickness behaviour is Tumour Necrosis Factor (TNF)-driven increases in extracellular glutamate leading to changes in neural function and brain network integrity and ultimately to sickness behaviour. Investigators hypothesise that TNF antagonism will effect changes in brain network connectivity and sickness behaviour score, that Rheumatoid Arthritis (RA) patients will show changes in brain network connectivity and glutamate quantification in the brain and that RA patients will show changes in monocyte infiltration into the brain that are correlated with changes in sickness behaviours. This is a randomised, placebo-controlled waiting list study. All patients will be eligible for anti-TNF treatment i.e. moderate to severe active disease as defined by Physician. Participants will be randomised to immediate (fast tracked) treatment or to treatment after 6-8 weeks (the routine waiting time). The latter group will receive placebo during the treatment phase.

Details

Lead sponsor	NHS Greater Glasgow and Clyde
Phase	NA
Status	COMPLETED
Enrolment	46
Start date	Fri Nov 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Nov 29 2024 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Rheumatoid Arthritis

Interventions

• Adalimumab
• Placebo

Countries

United Kingdom