The Efficacy, Safety and Cost-effectiveness of Hydroxychloroquine, Sulfasalazine, Methotrexate Triple Therapy in Preventing Relapse Among Patients With Rheumatoid Arthritis Achieving Clinical Remission or Low Disease Activity
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- the rate of recurrence
研究概览
简要总结
This trial aims to compare the cost effective and effect of preventing recurrence by different treatment of TFP and HCQ combined SSZ for remittent RA.
详细描述
patients were divided into 3groups: Group A:TFP+MTX (week0-week60) Group B:TFP+MTX+HCQ+SSZ(week0-week12) and then MTX+HCQ+SSZ(week13-week60) Group C:TFP+MTX (week0-week12) and then MTX (week13-week60)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill 2010 EULAR/ACR RA dignose criteria
- •Age18-70 years old
- •Have been teated regularly for 3 months
- •Disease duration > 6months
- •DAS28>3.2
排除标准
- •Received surgical operation in 8 weeks
- •Received other biological agent (eg. rituximab, anti-TNF agents, anti-IL6 agents)in 6 months;
- •Injection of steroid in 4 weeks
- •Coexisting with other CTD except for SS
- •With severe and not controled cardiac vescular disease, neurological disease, pulmonary disease (including COPD and ILD), renal disease, liver disease, endocrine disease and Gastric Intestinal Disease
- •With not controled diseases including asthma, IBD and psoriasis needing oral or injection of steroid
- •Active infection with T>38℃. Patients need admitted into hospital or biotics injection in 4 weeks or need oral biotics in 2 weeks
- •Malignant history.
- •Serum creatinine >130 µmol/L
- •AST/ALT higher than 2 times upper level
- •platelet count<100 x 109/L，or white blood count<3 x 109/L
- •Interstitail lung disease: Chest X Ray
- •Hands X Ray ACR radiology staging shows IV stage RA
- •Pregnancy or planing to pregnant in 2 years or suckling period women.
研究组 & 干预措施
A
Maintenance treatment group
干预措施: Entanercept (Drug)
A
Maintenance treatment group
干预措施: MTX (Drug)
B
Combination treatment group
干预措施: Entanercept (Drug)
B
Combination treatment group
干预措施: HCQ (Drug)
B
Combination treatment group
干预措施: MTX (Drug)
C
Single drug group
干预措施: Entanercept (Drug)
C
Single drug group
干预措施: MTX (Drug)
结局指标
主要结局
the rate of recurrence
时间窗: 60 weeks
次要结局
未报告次要终点
研究者
Zhuoli Zhang
Rheumatology and Immunology Department
Peking University First Hospital