An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World ["HUMAN" Study]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 8
- 主要终点
- Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
研究概览
简要总结
This study will be conducted to observe the disease activity change of Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from baseline to 6 months compared with cDMARDs, as measured by the disease activity score with the erythrocyte sedimentation rate (DAS28-ESR).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with rheumatoid arthritis within 3 years
- •Participants who have no experience with anti-tumor necrosis factor (anti-TNF)
- •Participants who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to informed consent
- •Participants who change the treatment regimen to one of the following according to the opinion of the investigator:
- •One cDMARD plus anti-TNF
- •Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated prior to informed consent
排除标准
- •Participants who may be pregnant or lactating women
- •Participants who have contraindication to anti-TNF
- •Participants who had participated in this study
结局指标
主要结局
Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
时间窗: Baseline; Month 6
DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
次要结局
- Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life(Up to 12 months)
- Change from Baseline in the DAS28-ESR at Month 3(Baseline; Month 3)
- Change from Baseline in the DAS28-ESR at Month 12(Baseline; Month 12)
- Clinical remission rate measured by DAS28-ESR(Up to 12 months)
- Success rates of dose-reduction and discontinuation of steroid(s)(Up to 12 months)