Treatment of Early Aggressive Rheumatoid Arthritis (TEAR)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 755
- 试验地点
- 1
- 主要终点
- Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)
研究概览
简要总结
The purpose of this study is to 1)to determine if it is better to treat all early RA patients with methotrexate in combination with hydroxychloroquine plus sulfasalazine or in combination with etanercept or reserve this treatment for patients who do not appropriately respond to methotrexate alone and 2) to determine which combination of methotrexate therapy is better
详细描述
The ultimate goal of RA is to eliminate symptoms, restoring the patient to normal physical, social, emotional, and vocational function, and preserving the structure and integrity of joints. While disease modifying anti-rheumatic drugs (DMARDs) have long been the cornerstone of RA therapy, the limitations of DMARDs have become increasingly apparent and investigators continue to gain insight into the pathogenesis of this disease. Recent evidence suggests that treatment earlier in the disease process with more aggressive approaches results in superior long-term outcomes compared to less intensive treatment regimens. Specifically, there is growing interest in the possibility that early "aggressive" treatment with combinations of DMARDs as initial treatment in efforts to potentially reduce the proportion of patients that advance to severe disability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of RA for less than or equal to 3 years
- •Be 18 years of age or older at the time of diagnosis
排除标准
- •Pregnant or lactating women
- •History of chronic infection, such as hepatitis, pneumonia, or chronic skin infections
- •Active TB or evidence of latent TB
研究组 & 干预措施
2
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
干预措施: sulfasalazine (Drug)
1
methotrexate (MTX) + etanercept
干预措施: methotrexate (Drug)
1
methotrexate (MTX) + etanercept
干预措施: etanercept (Drug)
2
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
干预措施: methotrexate (Drug)
2
methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
干预措施: hydroxychloroquine (Drug)
3
methotrexate (MTX) or MTX + Etanercept
干预措施: methotrexate (Drug)
3
methotrexate (MTX) or MTX + Etanercept
干预措施: etanercept (Drug)
4
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
干预措施: methotrexate (Drug)
4
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
干预措施: sulfasalazine (Drug)
4
methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
干预措施: hydroxychloroquine (Drug)
结局指标
主要结局
Disease Activity Score Erythrocyte Sedimentation Rate(DAS28-ESR)
时间窗: Change of the Mean of DAS28-ESR between weeks 48 - 102.
Outcome measured was the observed-group analysis of the DAS28-ESR between weeks 48 and 102. DAS28 is a calculated scale using a formula that includes the number of tender joints and swollen joints (28 joints maximum). The following is the calculation: DAS28 = 0.56 \* sqrt(tender28) + 0.28 \* sqrt(swollen28) + 0.70 \* ln(ESR) + 0.014 \* GH. The ESR is the rate at which red blood cells sediment in a period of one hour. The total range for the DAS28ESR goes from 0.0 to 9.2; this indicates the current activity of the rheumatoid arthritis of a subject. A DAS28 above 5.1 means high disease activity whereas a DAS28 below 3.2 indicates low disease activity.
次要结局
- Radiographic Disease Progression Between Baseline and Week 102 as Assessed by Van Der Heijde Modified Sharp Scores.(Year 2, Week 102)
