Trial Status: Open to Recruitment
MONITOR PsA - Multicentre ObservatioNal Initiative in Treat to target Outcomes in Psoriatic Arthritis
Psoriatic arthritis (PsA) is a type of inflammatory arthritis that can cause pain and joint damage if left untreated. It is estimated to occur in 15% of people with psoriasis affecting 150,000 people in the UK. PsA is associated with a reduced life expectancy related to the risk of comorbidities, particularly the metabolic syndrome.
The treatment recommendation for PsA is a ‘treat to target’ approach. Where treatment should aim to reach the target of disease remission and/or minimal disease activity.
In the Ticopa trial previously we have shown that a treat to target approach can improve arthritis, psoriasis, quality of life, pain and function for patients with PsA, however this approach is not widely used in healthcare. By using treat to target at each of the assessment visits in the MONITOR study we are aiming to see if it is beneficial to patients and sustainable within an NHS setting.
The key outcomes are to establish clinical effectiveness and costs allowing comparison with the Ticopa trial. Within MONITOR additional assessments are now being completed including participation, fatigue and emotional wellbeing. The costs of this pragmatic intervention will be established using health economic analysis.
This cohort further aims to support other research projects forming the basis of a Trials Within Cohorts (TWiCs) design. This method recruits a central cohort having treatment as part of standard care with regular observations and then adds pragmatic trials of alternative therapies. MONITOR patients who consent to be offered alternative therapies may be approached and offered an intervention as part of that trial.
Patients who are recruited into the MONITOR study are seen at clinic every 12 weeks from week 12 through to week 48 and are then seen every 6 months (at week 72 and week 96) and yearly thereafter. At each visit patients will undergo a clinical assessment which will include completion of some patient questionnaires. The results will allow the clinical care team to assess disease activity and plan appropriate treatment. Blood samples are taken at each visit and the results are examined to see if we can identify markers that can help us understand more about psoriatic arthritis and predict whether people will respond to different drugs.
This is an observational cohort study addressing outcomes in patients newly diagnosed with PsA. Participants will be treated with the recommended standard care for PSA and their outcomes will be monitored. This study will potentially be run at 15 UK sites. Up to 500 patients will be invited to participate across all hospitals involved.
Participants will be asked to continue in the cohort throughout the duration of their treatment in the clinic, with visits coinciding with standard healthcare appointments. Participants will be seen every 3 months in year 1, then every 6 months in year 2 and annually thereafter. If participants change therapy additional data will be collected at the time of switch.
Participants attend a face-to-face clinic appointment every 12 weeks for the assessments to be carried out to determine if the participant meets MDA. If the participant does not meet MDA, treatment will need to be escalated.
Data from participant completed questionnaires (patient reported outcome measures (PROMS)), clinical examination and routinely performed blood tests will be recorded at the time of study visits. Where assessments are performed remotely, participants will be asked to complete PROMs online or via postal questionnaires. It will be recorded onto an electronic database which will calculate the composite outcome measures (PASDAS and MDA) automatically.
The study forms the basis of a TWiCs design and randomised controlled trials (RCTs) are established within this cohort. The TWiCs design recruits a central cohort having “treatment as usual” with regular observations and adds pragmatic investigations of alternative treatments. A random group of eligible participants are selected from the cohort to be offered these alternative therapies with other members of the cohort acting as comparative controls.