Low Dose Rituximab as a First Line Biologic Therapy for the Treatment of DMARD Resistant Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- change in 28-joint disease activity index( DAS28)
研究概览
简要总结
In this project the investigators decide to evaluate the efficacy and safety of half dose mabthera (it means 500 mg infusion two weeks apart) in conventional drug resistant cases of rheumatoid arthritis. The investigators choose this drug because the use of anti-TNF drugs limited in the investigators refractory patients as the first line drugs because of its cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1987 ACR criteria for classification of RA
- •Positive for rheumatoid factor(RF)
- •Active RA despite therapy with conventional for at least 3 months as evidenced by DAS 28 > 3/2
- •Patients with active, resistant RA who didn't receive anti TNF agents.
排除标准
- •Patient with hypogammaglobulinemia
- •Patient with congestive heart failure (classIV)
- •Active current bacterial,viral,fungal,myocardial or other infections
- •Chronic hepatitis B or hepatitis C carriers
- •History of severe allergic reaction to human,humanized or murine monoclonal antibodies
- •History of malignancies
- •Pregnant women or lactating mothers 8) Patients with Chronic renal failure and hepatic disease.
研究组 & 干预措施
Rituximab
干预措施: Rituximab (Drug)
Methotrexate
干预措施: Rituximab (Drug)
结局指标
主要结局
change in 28-joint disease activity index( DAS28)
时间窗: Study duration was 6 months and the subjects were assessed for DAS 28 change at baseline, after 2 , 16 and 24 weeks.
disease activity score 28 formula which caculates based the number of tenderness and swelling of 28 joints and also ESR)
Change in European league against rheumatism(EULAR) response criteria
时间窗: Change in EULAR 2,16,24 weeks
次要结局
- Rituximab side effects(0,2,16,24 weeks)
研究者
Kamila Hashemzadeh
assisstant professor
Mashhad University of Medical Sciences