Therapy of Antibody-mediated Autoimmune Diseases by Bortezomib (TAVAB)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- change in disease specific antibody titers after application of Bortezomib
研究概览
简要总结
The aim of this pilot study is to investigate the application of proteasome inhibitor Bortezomib (Velcade®, approved for therapy of multiple myeloma) in patients with therapy-refractory antibody-mediated autoimmune diseases. The investigators hypothesis is that the proteasome inhibition will lead to reduced antibody titers and improved clinical outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 - 75 years at screening
- •ability to give written consent, informed written consent
- •negative pregnancy test at screening
- •therapy-refractory Myasthenia Gravis (generalized) or Systemic Lupus Erythematosus or Rheumatoid Arthritis
排除标准
- •Belimumab therapy within the last 6 months
- •B-cell-depletion therapy within the last 9 months
- •heart or kidney insufficiency
- •known intolerability to Bortezomib
- •participation in another interventional trial within the last 3 months
- •liver cirrhosis
- •preexistent sensory or motor polyneuropathy ≥ degree 2 (NCI CTC AE criteria), within 14 days before screening
- •hints on clinically apparent herpes zoster reactivation
- •active systemic infection, or viral infection (CMV, EBV) within last 6 month before screening
- •serologically active hepatitis B and /or C, known HIV infection
- •tumor disease currently or within last 5 years
- •clinically relevant liver, kidney or bone marrow function disorder
- •pregnancy or lactation
研究组 & 干预措施
Bortezomib (Velcade)
干预措施: Bortezomib (Drug)
结局指标
主要结局
change in disease specific antibody titers after application of Bortezomib
时间窗: 6 months after end of therapy (6 weeks) compared to baseline (before therapy)
Change in disease specific antibody titers (anti-ACh for myasthenia gravis, anti-dsDNA for systemic lupus erythematosus, anti-ACPA for rheumatoid arthritis) 6 months after end of Bortezomib therapy (duration 6 weeks) compared to baseline (before therapy).
次要结局
- need for hospitalisation(at regular intervals up to 30 weeks)
- Change in quality of life (Qol score)(at regular intervals up to 30 weeks compared to baseline)
- change in dose of immunosuppressive co-medication(at regular intervals up to 30 weeks compared to baseline)
- Change in disease specific antibody titer after Bortezomib application(at regular intervals up to 30 weeks compared to baseline)
- Change in Activities of Daily Living (Adl score)(at regular intervals up to 30 weeks compared to baseline)
- Change in number of antibody producing plasmablasts/cells(at regular intervals up to 30 weeks compared to baseline)
- Change in titers of protective antibodies (e.g. measles)(at regular intervals up to 30 weeks compared to baseline)
- Change in concentration of soluble mediators (e.g. IL-6)(at regular intervals up to 30 weeks compared to baseline)
研究者
Andreas Meisel
Prof. Dr.
Charite University, Berlin, Germany