Effectiveness of Belimumab After Rituximab in Resistant Primary Juvenile Sjogren's Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Respondence rate
研究概览
简要总结
The goal of this clinical trial is to explore the effectiveness of sequential use of rituximab and belimumab in the treatment of resistant primary juvenile Sjogren's syndrome.
Does sequential use of rituximab and belimumab reduce the activity of SS in resistant patients
Researchers will compare the disease activity before and after the treatment of sequential use of rituximab and belimumab to see if the therapy works to treat SS.
Participants will:
Recieve Rituximab each week for 2-4 times until B%<0.5% or B#<20×10^6/L Recieve Belimumab 4 weeks after the last use of Rituximab, and then every 4 weeks until week 28
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 5-18 years old.
- •Meets SS diagnostic AECG criteria or Japan criteria.
- •classification for "resistant patients": Application of two or more immunosuppressants or prednisone +immunosuppressive therapy for more than 3 months. One of the following conditions still exists: a) systemic involvement: polyarthritis, vasculitis, autoimmune cytopenia or involvement of skin, kidney, lung, nerve, and liver. b) constituted B cell activation: elevated IgG, light chain, high β 2MG, C4 decrease, cryoglobulinemia, monoclonal antibody c) sustained increased inflammatory markers, such as ESR
- •Agree to receive the treatment of rituximab combined with belimumab
排除标准
- •Previously treated with rituximab within six months, or previously treated with other biologics, including belimumab or Telitacicept
- •Participate in other clinical trials within 6 months
- •eGFR<30ml/min
- •Active infections, including but not limited to: -- Current or past infection with hepatitis B or C as defined by: Hepatitis B surface antigen positive. Hepatitis B surface antibody positive and hepatitis B core antibody positive. Hepatitis C antibody positive. -- Historically positive HIV test or test positive at screening for HIV. -- Active tuberculosis.
- •Infection history: -- Currently on any suppressive therapy for a chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria) -- Hospitalisation for treatment of infection within 60 days of Day
- •- Use of parenteral (intravenous or intramuscular) antibiotics (anti-bacterials, antivirals, anti-fungals or anti-parasitic agents) within 30 days of Day
- •- Receipt of a live-attenuated vaccine within 3 months of Day
- •- In the investigator's opinion, participants that are at high risk for infection (including but not limited to in dwelling catheter, dysphagia with aspiration, decubitus ulcer, history of prior aspiration pneumonia or recurrent severe urinary tract infection).
- •Primary immunodeficiency
- •History of malignant neoplasm
- •Severe, progressive or uncontrolled renal, hepatic, haematological, gastrointestinal, pulmonary, cardiac or neurological disease or, in the investigator's opinion, any other concomitant medical condition or significant abnormal laboratory value that places the participant at risk by participating in this trial with the exception of diseases or conditions related to active SS
- •Comorbidities not SS related currently requiring systemic corticosteroid therapy.
- •Within 10 days before the first administration of Belimumab, IgG<4g/L or IgA<0.1g/L
- •WBC<1.5 × 109/L within 10 days before the first administration of Belimumab or neutrophils<1 × 109/L
研究组 & 干预措施
sequential use of rituximab and belimumab
干预措施: Rituximab (Drug)
sequential use of rituximab and belimumab
干预措施: Belimumab (Drug)
结局指标
主要结局
Respondence rate
时间窗: Week 28
In the context of the aforementioned criteria, a response is defined as the alteration of more than three of the following five indicators: a) Improvement of physician global assessment score by ≥30% b) Decrease in erythrocyte sedimentation rate (ESR) by ≥30% or normalization c) Improvement of B cell activation markers (IgG, RF) by ≥25% d) Improvement of lacrimal gland function: Improvement of Schirmer test by ≥5mm e) Improvement of salivary gland function: Increase in salivary flow rate by 25% or decrease in ultrasound score by ≥25%.
次要结局
- Score of salivary ultrasounds(week 0 and 28)
- Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 28(week 0 and 28)
- Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 28(week 0 and 28)
- the Sjögren's Tool for Assessing Response (STAR)(week 28)
- salivary flow rate(week 0 and 28)
- Schirmer test(Week 0 and 28)
研究者
Hongmei Song
Professor
Peking Union Medical College Hospital