A Multicentre Observational Psoriatic Arthritis Cohort Study Addressing Real-life Outcomes of a Treat to Target Approach in Routine Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 446
- 试验地点
- 2
- 主要终点
- Psoriatic arthritis disease activity score (PASDAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Standard care cohort
This study is observational. Patients will receive standard treatment as given in usual clinical practice with no intervention as part of the study. As per current clinical practice guidelines and UK reimbursement rules for biologics in PsA, patients will receive a pragmatic treat to target approach using step up standard therapies. Patients will usually receive methotrexate first line, initially 15mg ow increasing to 25mg ow as tolerated. In case of non-response, an additional DMARD will be used (sulfasalazine up to 3g daily or leflunomide 20mg od). If two DMARDs are failed and patients are eligible for biologic therapy under UK National Institute of Health and Clinical Excellence (NICE) guidance, then biologics will be used.
干预措施: Methotrexate (Drug)
结局指标
主要结局
Psoriatic arthritis disease activity score (PASDAS)
时间窗: 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.
Psoriatic Arthritis Disease Activity Score (PASDAS)
时间窗: 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.
次要结局
- Healthcare costs(48 weeks)
- Treatment satisfaction questionnaire for medications (TSQM)(48 weeks)
- Psoriatic Arthritis Impact of Disease (PsAID)(48 weeks)
- Health related quality of life(48 weeks)