STRIDE-PsA: A Study of Treatment Response and Immunogenicity in Sequential Biologic and Targeted Synthetic Disease-Modifying Antirheumatic Drug (b/tsDMARD) Exposure in Psoriatic Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Clinical Disease Activity in Psoriatic Arthritis (cDAPSA)
研究概览
简要总结
The goal of this observational study is to evaluate how well advanced therapies work in adults with psoriatic arthritis (PsA) who are starting a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as part of routine care.
The main questions are:
- Do treatment responses differ according to the number of previous advanced therapies?
- Can anti-drug antibodies (ADAs) or blood drug levels help predict treatment effectiveness?
Researchers will compare participants receiving earlier-line versus later-line advanced therapies to assess differences in treatment response and antibody development.
Participants will allow collection of routine clinical assessment data, complete questionnaires on symptoms and quality of life, and provide blood samples before treatment and at 12 weeks.
详细描述
Study Design and Objectives
STRIDE-PsA is a prospective, multicentre observational cohort study conducted within routine NHS rheumatology care. Approximately ten NHS sites will recruit adults with psoriatic arthritis (PsA) initiating a new biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD). Participants will be followed for 52 weeks with assessments at baseline and weeks 4, 12, 24, and 52. As this is a non-interventional study, treatment decisions and clinical management will remain at the discretion of the treating clinician.
The study aims to evaluate treatment effectiveness across different lines of advanced therapy and to investigate whether anti-drug antibodies (ADAs) or circulating drug levels are associated with clinical response. The underlying hypothesis is that patients may achieve comparable clinical improvement despite multiple prior therapy switches.
Study Procedures and Data Collection
Participants will be followed for 52 weeks with assessments aligned to routine NHS rheumatology care. Data collection will include clinical examinations, patient-reported outcome measures (PROMs), and blood sampling for ADA and drug level analysis.
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
- •Age ≥18 years
- •Clinical diagnosis of PsA meeting CASPAR criteria
- •Starting a new b/tsDMARD, irrespective of line of therapy
排除标准
- •Switching b/tsDMARD therapy for psoriasis or spondyloarthritis alone, without active psoriatic arthritis.
- •Previous treatment with the same b/tsDMARD being started at baseline.
- •Inability or unwillingness to provide informed consent.
研究组 & 干预措施
Fourth/Fifth-line Advanced Therapy
Participants with PsA initiating a fourth or fifth b/tsDMARD as part of routine care after multiple prior advanced therapy switches.
干预措施: Biologic or targeted synthetic DMARD (b/tsDMARD) (Drug)
Sixth-line or Later Advanced Therapy
Participants with PsA initiating a sixth or subsequent b/tsDMARD during routine clinical care.
干预措施: Biologic or targeted synthetic DMARD (b/tsDMARD) (Drug)
Second/Third-line Advanced Therapy
Participants with PsA initiating a second or third b/tsDMARD following prior advanced therapy exposure. All treatments are part of routine clinical care.
干预措施: Biologic or targeted synthetic DMARD (b/tsDMARD) (Drug)
First-line Advanced Therapy
Participants with PsA initiating their first biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as part of routine NHS clinical care. Treatment is prescribed by the treating clinician and not assigned by the study.
干预措施: Biologic or targeted synthetic DMARD (b/tsDMARD) (Drug)
结局指标
主要结局
Clinical Disease Activity in Psoriatic Arthritis (cDAPSA)
时间窗: Weeks 0/12
The cDAPSA is the primary outcome and is a validated composite measure of disease activity in PsA. It is calculated as the sum of the tender joint count (0-68 joints), swollen joint count (0-66 joints), patient global assessment of disease activity (0-10 cm visual analogue scale), and patient assessment of arthritis pain (0-10 cm VAS). Unlike the full DAPSA, cDAPSA does not include C-reactive protein. Scores provide a continuous measure of disease activity, with established thresholds to categorise disease states: remission (≤4), low disease activity (\>4-13), moderate disease activity (\>13-27), and high disease activity (\>27).
次要结局
- Body Surface Area of Psoriasis (BSA)(Week 0/12)
- Minimal Disease Activity (MDA)(Weeks 0/12)
- Psoriatic Arthritis Impact of Disease-9 (PsAID-9)(Weeks 0/4/12/24/52)
- Health Assessment Questionnaire-Disability Index (HAQ-DI)(Weeks 0/4/12/24/52)
- Patients' Global Assessment of Disease Activity (PGADA VAS)(Weeks 0/4/12/24/52)
- Duration of time on b/tsDMARD(Weeks 0/4/12/24/52)
- Patient completed disease flare questionnaire (FLARE)(Weeks 0/4/12/24/52)
- Anti-drug antibody (ADA) and non-trough drug levels(Weeks 0/12)