School of Infection & Immunity

Study Summary (including aims, timelines and funder):

Psoriatic arthritis (PsA) is an inflammatory arthritis which affects both joint (inflammatory arthritis) and skin (psoriasis). In recent decades, the introduction of extraordinarily effective treatments have transformed patient outcomes. However, a considerable number of patients continue to experience persistent chronic pain, despite apparent disease remission. This may be explained by the existence of alternative sources of pain. We believe that pain is not only caused by joint inflammation, but also the nervous system (brain and nerves).,We call this the  centralised component of pain.

Several studies have explored the central component of pain in different rheumatic diseases, such as rheumatoid arthritis, systemic lupus erythematosus, and fibromyalgia. Currently, there are no investigations exploring this type of pain in PsA. Even though there are treatments available to manage centralised pain, there are not the clinical tools or biomarkers to help distinguish the different sources of pain.  These are vital to improve the management and ultimately the quality of life of patients.

The CENTAUR study aims to characterise centralised pain in PsA patients. To do this, we are going to use comprehensive measurement including objective pain sensory tests and Magnetic Resonance Imaging (MRI) brain scans alongside  questionnaires and diseases activity measurements.

The primary research objective is to investigate the neurobiology of PsA patients, especially in patients with high centralised pain.

The secondary research objective is to develop a simple questionnaire which may be used routinely in clinic to characterise the type of pain reported by the patients and finally to inform precise treatment decisions.

This observational study will recruit 50 patients with PsA who are due to start a new disease modifying drug (DMARD) as part of standard clinical care. Clinical data, objective and subjective pain assessments will be collected at baseline and selected measures will be repeated at 3 and 6 months.

The recruitment is expected to start in April 2019 and it will conclude at the end of July 2021. 

The study is funded by Versus Arthritis (previously named Arthritis Research UK).

Who can participate? (Inclusion/exclusion criteria)

Patients with a diagnosis of PsA who have evidence of active disease active disease and are due to start a new disease modifying drug (DMARD) as part of their standard clinical care. 

Patients with any contraindication to MRI or with peripheral neuropathy can be not be enrolled in the study.

What does the study involve? 

Eligible patients who agree to participate will attend the clinical research facility at baseline, 3 and 6 months. 

At the baseline visit, the patient will undertake a clinical assessment, blood samples, questionnaire, quantitative sensory testing (QST), and a MRI brain scan. The clinical assessment and blood samples will reflect standard care. The questionnaire will assess symptoms and risk factors of pain. The QST is a well standardised set of tests suitable to measure sensitivity of pressure and visual stimuli. The MRI scan will be recording structural and functional information of the participant brain with particular focus on that areas known to be involved in pain. 

At the 3 and 6 months visits, only the clinical assessments, blood sampling and questionnaire assessments will be performed.

Are there any benefits or risks associated with taking part in this study?

A benefit from taking part in this study may not be directly achieved. However, the future results will help patients with PsA and rheumatic diseases in general. Moreover, joining a clinical trial may reveal a new medical condition that will be properly follow up and treated.

MRI is a very well-known imaging test which is overall safe. It does not involve the use of any radiation. Patients with contraindications to the MRI scan, such as metal implants or claustrophobia, will be appropriately excluded. QST is a set of different procedures commonly employed in research which have been planned following safety standards. However, a temporary discomfort may arise in the areas tested.  

Study contacts for further information 

Dr Flavia Sunzini (Clinical Research Fellow):  Flavia.Sunzini@glasgow.ac.uk

Dr Neil Basu (Chief Investigator): Neil.Basu@glasgow.ac.uk