The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Change in DAS28 score
研究概览
简要总结
SYBRA is an open-label, phase 3, randomized controlled clinical trial that aims to assess the use of synovial biopsies in predicting response to biologic therapy in patients with rheumatoid arthritis that have failed disease-modifying drugs. The project has the potential to help change the current practice by offering the best treatment option. The decision to choose the best treatment for a particular patient is especially important in the context of the growing number of therapies available as a first-line option and the lack of specific biomarkers to predict response to treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject should be capable of consent
- •Age 18 and older
- •Classified as rheumatoid arthritis as per EULAR/ACR criteria 2010
- •Failed one DMARD (Methotrexate, leflunomide, Sulfalsalazine, hydroxychloroquine)
- •Can be on steroid dose <7.5mg
- •Quantiferon negative
- •Hepatitis B, C negative
- •No recent history (<5y) of malignancy
排除标准
- •Overlap syndrome
- •Previously treated with a biological medication
- •Heart failure NYHA III/IV
- •Active tuberculosis
- •Active infections
- •Previous history of DVT, PE, or Stroke
- •Other significant comorbidities that will prevent them from taking any biologic medication as per EULAR guidelines on treating rheumatoid arthritis
- •Pregnancy
研究组 & 干预措施
Group B (JAK inhibitor)
Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the lymphoid- myeloid phenotype will be assigned to receive JAK inhibitor medication at the discretion of the treating physician.
干预措施: JAK inhibitor (Drug)
Group C (Anti-TNF or JAK inhibitor)
Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the pauci-cellular phenotype will be randomized to either anti-TNF or JAK inhibitor medication 1:1.
干预措施: Anti-TNF (Drug)
Group A (Anti-TNF)
Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the diffuse myeloid phenotype will be assigned to receive anti-TNF medication at the discretion of the treating physician.
干预措施: Anti-TNF (Drug)
Group C (Anti-TNF or JAK inhibitor)
Rheumatoid arthritis patients that have failed DMARD therapy will undergo a synovial biopsy under ultrasound guidance and sterile technique. Upon analysis of the sample, patients that are falling into the pauci-cellular phenotype will be randomized to either anti-TNF or JAK inhibitor medication 1:1.
干预措施: JAK inhibitor (Drug)
结局指标
主要结局
Change in DAS28 score
时间窗: Baseline, Visit 3 (12 weeks)
Change in DAS28 score indicating remission compared to baseline in at least 50% of patients, where DS28\<2.6 indicated remission. \* DAS score: disease activity score, where \<2.6 indicates remission, 2.6-3.2 low disease activity. 3.2-5.1 moderate disease activity; \>5.1 high disease activity; higher values suggest worse outcomes.
次要结局
- Change in cellular phenotype(Baseline, Visit 3 (12 weeks))
- Change in power Doppler activity(Baseline, Visit 3 (12 weeks))
- Change in HAQ score(Baseline, Visit 3 (12 weeks))