Special Investigation (Long-term Treatment in Patients With Rheumatoid Arthritis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 552
- 主要终点
- Incidence of Adverse Drug Reactions (ADRs)
研究概览
简要总结
The purpose of this study was to collect data on the incidence of adverse drug reactions, infections and malignant tumors, as well as factors that might affect the safety and effectiveness of Humira® (adalimumab; 40mg/0.8 mL) in Japanese participants who received the drug for the treatment of rheumatoid arthritis.
详细描述
Rheumatoid arthritis is a chronic autoimmune disease which requires long-term treatment. Due to the need of long-term safety data in Japanese participants and to fulfil the conditions of approval of adalimumab by the Japanese regulatory authority, this post-marketing observational study (PMOS) was conducted. The study investigated the long-term safety of adalimumab, particularly associated with the development of infections and malignant tumors. Data was collected once every 6 months up to 3 years.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence of Adverse Drug Reactions (ADRs)
时间窗: From the initiation of adalimumab treatment, every 6 months up to 3 years.
An ADR was any unfavourable or unintended response (adverse event) that could possibly be related to adalimumab treatment. ADRs were assessed and data are presented as percentage of participants.
次要结局
- Percentage of Participants With Disease Activity Score 28 - 4 Erythrocyte Sedimentation Rate (DAS28-4ESR) < 2.6 by Visit(Baseline (Week 0), Week 4, Week 12, Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3)
- Percentage of Participants With Modified Health Assessment Questionnaire (MHAQ) Score ≤ 0.5 by Visit(Baseline (Week 0), Week 24, Year 1, Year 1.5, Year 2, Year 2.5, and Year 3)
- Incidence of Infections and Malignant Tumors(From the initiation of adalimumab treatment, every 6 months up to 3 years.)