Investigating Clinical Heterogeneity in Immune Checkpoint Inhibitor-induced Inflammatory Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Disease activity as assessed by the Clinical Disease Activity Index (CDAI)
研究概览
简要总结
Immune checkpoint inhibitors (ICI) can cause immune related adverse events like inflammatory arthritis (ICI-IA). ICI-IA is a new and impactful condition, but there is limited understanding of pathogenesis, natural history, and response to treatments. The study will have two main goals. 1. Evaluate efficacy of steroid sparing immunosuppression and determinants of ICI-IA persistence. 2. Identify biomarkers that predict ICI-IA disease severity and initial treatment-associated response.
These questions will be answered using the RADIOS cohort, a prospective cohort of patients with rheumatic immune related adverse events due to ICI therapy.
详细描述
Immune checkpoint inhibitors (ICI) were first approved in the US in 2011, and ICI-induced inflammatory arthritis (ICI-IA) was first described in the literature in isolated case reports and then in the investigator's case series in 2015-2016. ICI-IA has been recognized as a disease entity for only 10 years, thus there are fundamental features of the disease which are yet to be defined. These include understanding the clinical heterogeneity of ICI-IA, factors influencing treatment selection and response to treatment, and prognostic biomarkers for ICI-IA persistence, all of which will be addressed in the proposed studies. The RADIOS consortium, a multicenter consortium already approved as a research resource at Johns Hopkins, will provide all clinical data for this study. Investigators at outside sites that are part of the RADIOS consortium are collaborating to add their expertise in statistical analysis and to have an adequate number of samples for the biomarker work.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in RADIOS (IRB00263113) with immune checkpoint inhibitor-induced inflammatory arthritis will be included.
排除标准
- •Preexisting systemic autoimmune disease
结局指标
主要结局
Disease activity as assessed by the Clinical Disease Activity Index (CDAI)
时间窗: baseline, at 2-4 month follow up visit, at 3 months and 6 months post ICI cessation
Add four numbers to get a total score from 0 to 76. 1)Tender Joint Count (0-28): How many of 28 specific joints hurt when touched. 2)Swollen Joint Count (0-28): How many of 28 specific joints are swollen. 3)Patient Global Assessment (0-10): How the patient feels their overall health is doing. 4)Provider Global Assessment (0-10): How the doctor feels the patient's disease is doing.
次要结局
未报告次要终点