A Pilot Study of Rituximab for the Anticoagulation Resistant Manifestations of Antiphospholipid Syndrome (RITAPS)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Serious and Non Serious Adverse Events
研究概览
简要总结
RITuximab AntiphosPholipid Syndrome (RITAPS) Study is designed to evaluate whether a medication called rituximab would reduce the signs and symptoms of antiphospholipid antibody (aPL) -related certain clinical problems.
详细描述
Persistently antiphospholipid antibody (aPL)-positive patients, age 18 - 75 years of age, with anticoagulation-resistant manifestations of APS and fulfilling protocol defined study inclusion criteria will receive two doses of Rituximab, and will be followed for 6 and 12 months for clinical and safety outcomes, respectively.
Patients are eligible to take part in this study if their blood test is persistently positive for aPL and they have one or more of the aPL-related clinical problem(s) listed below: low platelet (blood cells involved in the prevention of bleeding) count; anemia (deficiency of red blood cells); heart valve disease; skin ulcers; kidney smal vessel blood clots; and/or memory problems.
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
- •- Positive aPL profile defined as:
- •Positive lupus anticoagulant test as defined by the International Society on Thrombosis and Haemostasis, on two or more occasions, at least 12 weeks apart and/or
- •Positive anticardiolipin antibody (aCL) immunoglobulin G(Ig)G/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart and/or
- •Positive anti-β2-glycoprotein-I (aβ2GPI) IgG/M/A isotype, present in > 40U, on two or more occasions, at least 12 weeks apart
- •Clinical features attributable to aPL that are resistant to warfarin and/or heparin:
- •Persistent thrombocytopenia and/or
- •Persistent autoimmune hemolytic anemia and/or
- •Cardiac valve disease and/or
- •Chronic skin ulcers and/or
- •Renal thrombotic microangiopathy and/or
- •Cognitive dysfunction with/without white matter changes
- •Exclusion Criteria (selected):
- •> 4/11 American College of Rheumatology Classification Criteria for SLE
- •Acute thrombosis
- •History of stroke (only for patients with cognitive dysfunction)
- •Positive Hepatitis B or C serology
- •History of positive HIV
- •Acute or chronic pancreatitis
- •Treatment with any investigational agent within 4 weeks of screening
- •Receipt of a live vaccine within 4 weeks prior to randomization
- •Previous Treatment with Rituximab (MabThera® / Rituxan®)
- •Previous treatment with Natalizumab (Tysabri®)
- •Known active bacterial, viral fungal mycobacterial, or other infection
- •Pregnancy
- •Concomitant malignancies or previous malignancies, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- •History of psychiatric disorder that would interfere with normal participation in this protocol
- •Significant cardiac or pulmonary disease
排除标准
- 未提供
研究组 & 干预措施
Rituximab
All patients will receive 1000 milligrams of rituximab by intravenous infusion on Days 1 and 15.
干预措施: Rituximab (Drug)
结局指标
主要结局
Number of Participants Experiencing Serious and Non Serious Adverse Events
时间窗: 52 weeks + additional 4 months if needed
Serious and non-serious adverse events were evaluated throughout 52 weeks + additional 4 months for the patients with low B cell counts.
次要结局
- The Efficacy of Rituximab(24 weeks)