POISE
Research type
Research Study
Full title
Clinical effectiveness of symptomatic therapy compared to standard step up care for the treatment of low impact psoriatic oligoarthritis: a 2 arm parallel group feasibility study.
IRAS ID
236772
Contact name
Laura Coates
Contact email
Sponsor organisation
University of Oxford
Eudract number
2018-001085-42
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Summary of Research
Psoriatic Arthritis (PsA) is an inflammatory arthritis estimated to occur in 15% of people with psoriasisaffecting around 150,000 people in the UK. Two-thirds of people with PsA suffer progressive joint damage with associated disability.People with PsA have similar functional and quality of life impairment to rheumatoid arthritis. PsA is associated with a reduced life expectancyrelated to the risk of comorbidities, particularly the metabolic syndrome. PsA is a highly heterogenous disease with a proportion of Participants having mild non-progressive disease. Well validated prognostic factors in PsA can identify these Participants including number of active joints, systemic inflammation levels, radiographic damage and functional ability at presentation. It is likely that some Participants are over treated with conventional ‘step up’ therapy leading to unnecessary side effects for the patient and costs to the healthcare system. In established disease ultrasound (US) inflammation in the joints predicts future flare of disease in those already on treatment.
This trial will investigate the feasibility and acceptability of the study design to establishwhether Participants with mild PsA can be managed without DMARDs. Participants with newly diagnosed PsA will be eligible if they fulfil the following criteria:
1. Oligoarthritis (<5 joints involved)
2. Low disease activity (measured by PASDAS <3.2)
3. Low impact of disease (PSAID ≤4)
This data will enable me to design and power a definitive trial of delayed DMARD treatment for mild PsA.
The intervention will delay standard treatment with disease-modifying anti-rheumatic drugs (DMARDs) and use local steroid injections to affected joints instead. Oral non-steroidal anti-inflammatory drugs (NSAIDs) will also be allowed as concomitant medication as indicated for individuals. Local steroid injections will include injections with methylprednisolone or triamcinolone.
In case of requirement of more than 2 local injections to any specific joint within a 6 month timeframe, Participants will be withdrawn from the treatment protocol and be treated as per usual care (in most cases with disease-modifying anti-rheumatic drugs (DMARD) therapy). This is to ensure that risks in delaying treatment are mitigated.
This trial is nested within a cohort (MONITOR-PsA) forming the basis of a Trials Within Cohorts (TWiCs) design. This method recruits a central cohort having “treatment as usual” with regular observations and then adds pragmatic trials of alternative therapies where a random group of eligible Participants are selected. This allows robust generalizability from studies to routine health care, avoids attrition and disappointment bias from controls in open label studies as Participants only receive information relevant to their care, aids recruitment to trials, allows routine collection of long term outcomes and increases efficiency with multiple trials within one cohort. This will allow us to address outcomes with a pragmatic ‘treat to target’ approach in a real-life cohort and compare other therapeutic interventions. This design is particularly suited to open label trials with “treatment as usual” as the comparator. It is ideal for chronic conditions, situations where multiple trials may be performed and where expensive desirable treatments are being trialed. Thus Participants in this POISE study will be recruited from and followed as part of the MONITOR cohort.Summary of Results
: Psoriatic arthritis (PsA) is a type of arthritis that develops in around 15% of people with the skin condition psoriasis, causing swollen and painful joints. We currently use a ‘step-up’ approach for all patients, whether they have mild or severe disease. It is possible that patients with mild disease may not need any of these treatments, suffering unnecessary side effects such as sickness, stomach upsets, infections and liver problems. Our aim was to see if it would be possible to run a trial looking at whether patients with mild disease can be treated successfully without being put onto more powerful arthritis drugs.
The POISE study aimed to assess whether a trial was feasible for patients with mild disease to go without standard arthritis drugs. Unfortunately, only one patient was recruited during the study and allocated to standard care. This suggests that the study was not feasible in its current form.
The study showed that a small number of patients in the clinic have mild disease and agreed to join the underlying cohort study. We were not able to assess how many would agree to delay treatment or required repeated steroid injections. In our experience, there were a number of patients with mild disease who were not keen to receive standard arthritis drugs which limited recruitment. A future trial to see whether patients with mild disease can manage with less treatment will need a different design to have successful recruitment.REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0261
Date of REC Opinion
24 May 2018
REC opinion
Further Information Favourable Opinion