JPRN-jRCTs031230485招募中2 期
Exploratory research on therapeutic optimization parameters for upadacitinib by single-cell analysis of synovial tissue and peripheral blood from rheumatoid arthritis and psoriatic arthritis patients
Fujio Keishi0 个研究点目标入组 40 人开始时间: 2023年11月30日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1). Patients with RA or PsA (for RA, patients must fulfill the 2010 ACR/EULAR classification criteria, and for PsA, patients must fulfill the CASPAR classification criteria).
- •(2). Patients with disease activity (TJC>=3 and SJC>=3).
- •(3). Patients aged 18 years and above.
- •(4). Patients who have had inadequate efficacy or difficulty continuing with one or more csDMARDs and one or fewer bDMARDs due to insufficient effectiveness or adverse events.
- •(5). Gender: Not restricted.
- •(6). Patients who have received sufficient explanation regarding participation in this study, have understood it adequately, and have provided written consent based on their own free will.
- •(7). Patients who can attend outpatient visits in accordance with the study implementation schedule.
- •(8). Patients for whom residual samples of synovial tissue have been collected and stored for purposes other than this study within the 4 weeks prior to obtaining consent.
排除标准
- •(1). Patients with a history of hypersensitivity to components of upadacitinib (UPA).
- •(2). Patients with active severe infections.
- •(3). Patients with active tuberculosis.
- •(4). Patients with severe liver dysfunction (Child-Pugh Score C).
- •(5). Patients who are carriers or have a history of hepatitis B virus (negative for HBsAg and positive for either HBcAb or HBsAb). However, if HBV DNA is negative, participation is possible with attention to signs and symptoms of hepatitis B virus reactivation while monitoring liver function test values and HBV DNA.
- •(6). Patients who are carriers of hepatitis C virus.
- •(7). Patients with neutrophil count < 1000 / mm3, lymphocyte count < 500 / mm3, or Hb < 8 g/dL.
- •(8). Patients who are pregnant or possibly pregnant.
- •(9). Other individuals deemed inappropriate for participation in this study by the principal investigator or participating physicians.
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