Psoriatic Arthritis
Conditions
Keywords
treat to target
Brief summary
MONITOR is a cohort study recruiting patients with a new diagnosis of psoriatic arthritis (PsA) which will establish outcomes using a pragmatic feasible 'treat to target' approach in a real-life clinic population. It is the central cohort for a planned Trials Within Cohorts (TWiCs) design which will test alternative therapies and interventions in embedded clinical trials comparing outcomes to those receiving "standard care" in the cohort.
Detailed description
Psoriatic Arthritis (PsA) is an inflammatory arthritis estimated to occur in 15% of people with psoriasis, affecting around 150,000 people in the United Kingdom (UK). The 2015 European League Against Rheumatism (EULAR) Treatment recommendations for PsA incorporating as its first recommendation that "treatment should be aimed at reaching the target of remission or, alternatively, minimal/low disease activity, by regular monitoring and appropriate adjustment of therapy". Despite the evidence and the EULAR recommendations supporting 'treat to target' in PsA, it has not been widely implemented due to concerns about feasibility and cost-effectiveness. This cohort will establish a pragmatic feasible 'treat to target' approach in a real-life clinic population which we believe can provide similar clinical and health-related quality of life outcomes. The primary outcome will be the proportion of patients achieving a good response measured by the PsA Disease Activity Score (PASDAS) at 48 weeks. Additional domains including participation, fatigue and emotional wellbeing will be assessed for the first time. Finally the costs of this pragmatic intervention will be established using health economic analysis.All patients will receive treatment as usual following the current British Society of Rheumatology (BSR) and EULAR guidance as standard of care. As a cohort for a "Trials within Cohorts" or TWiCs design, the patients consenting to participate will also be asked if they consent to be approached for future interventional trials linked to the cohort and whether they consent for their data to be used as a comparator in these future interventional studies.
Interventions
DRUGMethotrexate
This study is observational and patients will receive treatment for their psoriatic arthritis as clinically indicated. As per standard practice in this observational cohort, patients are most likely to be treated with methotrexate as the most common first line therapy in PsA. This cohort is the basis of a TWiCs (Trials Within Cohorts) study design and interventional studies will be nested within this in future. Whilst the cohort will receive treatment for their PsA as part of their routine clinical care, this treatment will be decided according to routine care and not protocolised.
Sponsors
University of Oxford
National Institute for Health Research, United Kingdom
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is willing and able to give informed consent for participation in the study. * Male or Female * Aged 18 years or above. * Clinical diagnosis of PsA based upon the Classification of PsA (CASPAR) criteria(23)) * Active PsA defined by ≥1 tender or ≥1 swollen joint or ≥1 enthesis (site of attachment of tendon to bone) * Not previously received treatment with synthetic or biologic disease-modifying anti-rheumatic drugs (DMARDs) for their articular disease. * In the Investigator's opinion, is able and willing to comply with all study requirements.
Exclusion criteria
* Current or previous treatment of arthritis with synthetic DMARDs (including methotrexate, leflunomide or sulfasalazine) or biologic DMARDs (including tumour necrosis factor (TNF), interleukin (IL)12/23 or IL17 inhibitor therapies) or targeted synthetic DMARDs (phosphodiesterase (PDE) 4 or Janus kinase (JAK) inhibitor therapies). * Use of investigational therapies within 1 month or 5 biological half-lives of the baseline study visit(whichever is longer) * Women who are pregnant, nursing or planning pregnancy during the following 12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriatic Arthritis Disease Activity Score (PASDAS) | 48 weeks | A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as \<3.2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Psoriatic Arthritis Impact of Disease (PsAID) | 48 weeks | A questionnaire assessing the overall impact of disease on a patient. This is a scale of 12 questions (scored 0-10) which are combined with published weighting scales to one final 0-10 score where 0 is "no impact" and 10 is "maximal impact". There are no subscales. Patient acceptable symptom state is \<=4. |
Countries
United Kingdom
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 46 years |
| Psoriatic Arthritis Disease Activity Score (PASDAS) | 5.1 Units |
| Region of Enrollment United Kingdom | 300 participants |
| Sex: Female, Male Female | 139 Participants |
| Sex: Female, Male Male | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 300 |
| other Total, other adverse events | 0 / 300 |
| serious Total, serious adverse events | 0 / 300 |
Outcome results
None listed