NCT00555542已完成2 期
B Cell Depletion Therapy in Rheumatoid Arthritis: An Analysis of Peripheral Blood T Cell Subsets
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The proportion of patients who achieved a response according to the ACR 20 response criteria at 24 weeks and 54 weeks after the initial infusion
研究概览
简要总结
To study the effects of T cell in peripheral blood of patients with RA undergoing selective B cell depletion have not been studied. We analyze the B and T cell subsets in patients with active RA treated undergoing this form of treatment with rituximab.
详细描述
- In this open labeled prospective study, we evaluate the therapeutic efficacy and peripheral blood cellular response of rituximab in 10 patients with active RA despite conventional DMARDs therapy.
- Patients are taking stable dose of methotrexate and at least 10mg folic acid per week for at least 4 weeks. Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15. Premedication as standard prescription consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab. Oral prednisolone 60mg is tob e given from day 1-6 after rituximab infusion and 30mg from day 7-13.
- In patients who relapses following the first cycle can be repeated with the second cycle must fulfill the following conditions:
- Patients must have responded clinically to the first infusion with improvement
- Other disease modifying anti-rheumatic drugs (DMARDs) are not appropriate as determined by the investigators, either they have been on them before or are ineffective or due to side effects,
- Patients have a disease activity score DSA>2.6
- At least 24 weeks since the first infusion
- Neutrophil count of >1.5 X 103/mcL
- The second infusion consists of rituximab 1000mg intravenous infusion on day 1 and day 15 as before and the same protocol of followed up every 4 weeks up to 52 weeks from the day of the first infusion.14 Premedication as standard prescription (consists of methylprednisolone 100mg IV, Chlorpheniramine maleate(piriton) 10mg IV and oral paracetamol 500mg to be given 30 minutes before each infusion of rituximab.
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
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21 or above
- •Fulfilled the 1978 American college of Rheumatology(ACR) criteria for RA
- •Seropositive for RF with RF>20 IU/ml
- •Active disease despite treatment with at least 2 stable dose of DMARDs for at least 16 weeks, including MRX>10mg weekly
- •4 or more swollen and/or tender joints
- •Stable dose of prednisolone<=12.5mg/day or NASID for at lease 4 weeks
- •MTX>10mg/wk and folic acid>10 mg/wk for at lease 4 weeks
排除标准
- •Little or no ability for self-care
- •Used a DMARD other than MTX(Leflunomide should be wash-out with cholestyramine 4 weeks prior screening)
- •Received intra-articular,intramuscular, or intravenous corticosteroids in the last 4 weeks
- •Concurrent treatment with any biologics within 8 weeks
- •Infected joint prosthesis during the previous 5 years
- •Autoimmune disease other than RA(except concurrent Sjogren's syndrome), active rheumatoid vasculitis, and history of systemic disease associated with arthritis, chronic fatigue syndrome.
- •Serious infections, such as hepatitis, pneumonia, pyelonephritis in the previous 3 months
- •Any chronic infectious disease such as renal infection, chest infection with bronchiectasis or sinusitis
- •Recurrent bacterial infections with encapsulated organisms, primary or secondary immunodeficiency
- •Active tuberculosis requiring treatment within the previous 3 years
- •Opportunistic infection such as herpes zoster within the previous 2 months
- •Any evidence of active cytomegalovirus;active Pneumocystis Jirovecl;or drug-resistant atypical mycobacterial infection
- •Known hypersensitivity to murine proteins
- •Current signs or symptoms of severe,progressive,or uncontrolled renal,hepatic,haematological,gastrointestinal,endocrine,pulmonary,cardias,neurological,or cerebral disease
- •A history of lymphoproliferative disease including lymphoma or signs suggestive of disease,such as lymphadenopathy of unusual size or location(ie,lymphadenopathy nodes,in the posterior tangle of the neck,infraclavicular epitrochlear,or periaortic areas);splenomegaly
- •Any know malignant disease except basal cell carcinoma currently or in the last 5 years
研究组 & 干预措施
1
Experimental
Rituximab is administrated as 1000mg intravenous infusion on day 1 and day 15.
干预措施: rituximab (Drug)
结局指标
主要结局
The proportion of patients who achieved a response according to the ACR 20 response criteria at 24 weeks and 54 weeks after the initial infusion
时间窗: wk52
次要结局
- The proportion of patients who achieved a response according to ACR50,ACR70, physician's assessment of disease activity,patient's assessment of physical function by means of a health-assessment questionnaire(HAQ),quality of life measure by SF-36(wk52)
研究者
研究点 (1)
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