jRCTs011250076招募中不适用
Anifrolumab for Lupus Fatigue: Functional MRI Application in SLE (ALFA-SLE)
未提供0 个研究点目标入组 48 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 18age old over 至 60age old not（—）
- 性别
- All
入选标准
- •Patients who are at least 18 years and less than 60 years of age at the time of consent
- •Patients who have received a comprehensive explanation of their participation in this study and who have given their free and informed consent
- •Patients with < 43 points of fatigue scale (FACIT-F) for SLE within 28 days prior to enrollment (the same day of the week as the enrollment date is acceptable)
- •Patients who underwent fMRI evaluation within 28 days prior to enrollment
- •Patients who fulfilled the American College of Rheumatology classification criteria for SLE (revised in 1997) at the time of diagnosis
- •Patients who are scheduled to receive anifrolumab according to health insurance coverage
排除标准
- •SLE patients with severe organ complications including active (BILAG category A or B) neuro-psychiatric SLE (NPSLE) or lupus nephritis
- •Patients with other collagen diseases such as myositis and fibromyalgia. However, patients with Sjogrens syndrome may be enrolled.
- •Patients currently receiving treatment with anifrolumab or prohibited concomitant drugs and prohibited concomitant therapies. However, patients may be enrolled if the following days have passed since the last administration.
- •Anifrolumab : >= 90 days
- •Other anti-BAFF antibodies, including belimumab : >= 90 days
- •JAK inhibitors (tofacitinib, baricitinib, etc.) : >= 90 days
- •High-dose immunoglobulin therapy (IVIG), plasma exchange : >= 90 days
- •CD20 antibodies, including rituximab : >= 180 days
- •Live vaccines, cyclophosphamide : >= 30 days
- •Pregnant women, lactating women, or women who wish to pregnant during the study period.
- •Persons with strong suspicion of organic brain disease
- •Patients with serious physical diseases (heart, liver, kidney)
- •Patients with severe anemia (Hb < 7.0 g/dL) in the most recent test before enrollment
- •Those for whom MRI imaging is contraindicated or difficult to perform
- •Patients with active hepatitis B or active tuberculosis. However, the activity is determined by the investigator
- •Patients participating in clinical trials or prospective clinical studies
- •Other patients deemed inappropriate as study subjects by the site principal investigator