Comparative Effectiveness of Biologic Disease-modifying Antirheumatic Drugs and Small Molecular Inhibitors in Patients With Moderate to Severe RA: Prospective Observational Study
试验速览
- 阶段
- 不适用
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR)
研究概览
简要总结
The objective of a multicenter prospective observational study is to compare effectiveness and safety of biologic disease-modifying antirheumatic drugs and small molecular inhibitors in patients with moderately to severely active rheumatoid arthritis patients who have had an inadequate response or intolerace to methotrexate.
详细描述
This study is a multicenter prospective observational study to show non-inferiority of clinical efficacy for small molecular inhibitors after 48 week of treatment to biologic disease modifying anti-rheumatic drugs (bDMARDs) in patients having moderately to severely active RA and who have been intolerant to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) including methotrexate.
Primary end point is a percentage of participants of achieving low disease activity according to Disease Activity Score in 28 joints-Erythrocyte Sedientation Rate (DAS28-ESR) at weeks 24. A total of 506 RA patients will be included, and allocated in ratio of 1:1 to bDMARD group and small molecule inhibitor group. Group allocation is determined by shared-decision making, so that the number of participants could be re-assessed according to recruitment status of participatns.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are included in this study if they are:
- •19 years or olders
- •Patients who satisfy the 1987 American College of Rheumatology (ACR) or 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria for RA
- •Patients having moderately to severely active RA who are intolerant to csDMARDs including methotrexate and those who have never been exposed to bDMARDs or small molecular inhibitors before
- •Patients who provide written consent to participate in this study
排除标准
- •Patients who are contraindicated to bDMARDs or small molecule inhibitor
- •Patients who have plans for pregnancy or elective surgery
- •Patients who had ever diagnosed with any malignancy or are treated for malginancy
- •Patients who cannot voluntarily provie a written consent to participate in this study
- •Patients who did not provide a written consent to participate in this study
研究组 & 干预措施
RA patients who start bDMARD
The efficacy and safety of targeted therapy will be evaluated in RA patients who are treated with a biologic disease modifying antirheumatic drug (bDMARD) including Adalimuab, Etanercept, Tocilizumab or Abatacept after shared-decision making.
干预措施: Adalimuab, Etanercept, Tocilizumab, or Abatacept (Drug)
RA patients who start small molecule inhibitor
The efficacy and safety of targeted therapy will be evaluated in RA patients who are treated with a small molecular inhibitor including Tofacitinib or Baricitinib after shared-decision making.
干预措施: Tofacitinib or Baricitinib (Drug)
结局指标
主要结局
Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR)
时间窗: At weeks 24
Disease Activity Score 28 joints-Erythrocyte sedimentation (DAS28-ESR) below 3.2 indicates low disease activity of RA.
次要结局
- Changes in Health Assessment Questionnaire (HAQ)(At weeks 12, 24, and 48)
- Changes in EuroQol visual analogue scale (EQ VAS)(At weeks 12, 24, and 48)
- Changes in EuroQol-5 dimension (EQ-5D)(At weeks 12, 24, and 48)
- Percentage of participants achieving low disease activity according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)(At weeks 12 and 48)
- Percentage of participants having radiologic progression in RA (if possible)(At weeks 48)
- Percentage of participants having changes in ultrasonographic findings of RA (if possible)(At weeks 48)
- Percentage of participants achieving remission according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)(At weeks 12, 24, and 48)
- Percentage of participants with European League Against Rheumatism (EULAR) Response according to Disease Activity Score 28 joints-Erythrocyte sedimentation rate (DAS28-ESR)(At weeks 12, 24, and 48)
- Incidence of adverse events (AEs) or serious adverse events (SAEs) of targeted therapy (if possible)(At weeks 48)
- Biomarkers predictive of treatment response of RA (if possible)(At weeks 24)
- Compliance with targeted therapy defined by Patient-reported adherence and Modified Morisky scale (if possible)(At weeks 48)
研究者
Yoon-Kyoung Sung
Principal Investigator
Hanyang University