NCT01918267已完成不适用
U-Act-After: An Observational Study on Long-Term Efficacy of Tight Control RoActemra/Actemra (Tocilizumab) and/or Methotrexate in Patients With Early Rheumatoid Arthritis Who Have Participated in the U-Act-Early Study (ML22497)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 19
- 主要终点
- Change in Disease Activity Score (DAS28)
研究概览
简要总结
This non-interventional, observational, open-label multi-center follow-up study of patients from the U-Act-Early trial (ML22497) will evaluate the long-term efficacy and safety of starting tight control treatment with RoActemra/Actemra (tocilizumab) and/or methotrexate in patients early in the disease followed by treatment according to standard of care in routine clinical practice in a three year follow-up, independently of what treatment the patient will be receiving.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have participated in the U-Act-Early trial (ML22497); these are adult patients (> 20 years of age) with rheumatoid arthritis.
- •Patients must be willing to give written informed consent
排除标准
- •Patients who did not participate in the U-Act-Early trial
- •Patients who are drop-outs in the U-Act-Early trial due to withdrawal of consent, are lost to follow-up or are serious protocol violators
结局指标
主要结局
Change in Disease Activity Score (DAS28)
时间窗: from baseline to Month 36
次要结局
- Change in disability, assessed by the Dutch consensus Health Assessment Questionnaire (HAQ)(from baseline to Month 36)
- Changes in concomitant medication (especially tapering of corticosteroids)(from baseline to Months 36)
- Measure of progressive joint destruction (vdHSS)(from baseline of U-Act-Early to Month 24 of U-Act-After)
- Sustained remission rates/drug-free remission rates(36 months)
- Dose modifications/interruptions of RA treatment(36 months)
- Safety: Incidence of adverse events, adverse events of special interest and serious adverse events(36 months)
研究者
研究点 (19)
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