Sex Matters: Sex- And Gender-based Analysis of the Effectiveness of Advanced Therapies in Psoriatic Arthritis (SAGE-PsA) - an International Multicentre Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 1
- 主要终点
- Achievement of Minimal Disease Activity (MDA) state
研究概览
简要总结
Sex and gender are important factors that influence treatment response in PsA. The goal of this multi-centre observational study is to understand how sex and gender influence response to advanced therapies in psoriatic arthritis (PsA). The investigators hope to discover biological and socio-cultural mechanisms that explain the differences in treatment response between men and women with PsA.
The study investigators plan to recruit patients from approximately 30 sites across the world. Men and women with active PsA will be assessed before and after they start advanced therapies and information will be collected about sex- and gender-related factors through questionnaires and physical examination. Physicians will assess the patient response to treatment. The investigators will compare the response to treatment in men and women and assess what biological and socio-cultural factors contribute to differences in treatment response.
详细描述
Study investigators will perform a prospective, multi-center, international cohort study involving approximately 30 sites that specialize in care of patients with PsA. 540 patients with a rheumatologist-confirmed diagnosis of PsA who are initiating advanced therapy for peripheral musculoskeletal manifestations of PsA will be enrolled. The study will include 2 in-person physician visits. Visit 1 (baseline) will take place prior to drug initiation (up to 3 months prior). Visit 2 (follow-up) will occur 3-6 months following drug initiation. In addition, study sites will be asked to report persistence status on the study drug at 1 year.
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
- •Rheumatologist confirmed diagnosis of PsA according to CASPAR criteria
- •Age ≥18 years
- •Active PsA with any of the following manifestations detected on physical examination: peripheral arthritis, dactylitis, and enthesitis. The patient may have axial involvement in addition to the peripheral manifestations of PsA
- •Plan to start treatment with advanced therapies for peripheral musculoskeletal manifestations of PsA
排除标准
- •Unable to read or write
- •Unable to sign informed consent
- •Cannot return for a follow up visit
- •The drug is given for another indication and not for active PsA (e.g. psoriasis, IBD)
- •Pregnant women
结局指标
主要结局
Achievement of Minimal Disease Activity (MDA) state
时间窗: Within 3-6 months
The proportion of patients who have achieved the MDA state following treatment initiation
Achievement of the American College of Rheumatology (ACR) 20/50/70
时间窗: Within 3-6 months
The proportion of patients who have achieved the ACR 20/50/70 following treatment initiation
次要结局
未报告次要终点
研究者
Lihi Eder
Associate Professor, Department of Medicine
University of Toronto