Special Investigation in Japanese Rheumatoid Arthritis Patients Who Have no Previous Use of DMARDs and Biological Agents
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study was conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis participants showing rapid progression of structural damage of the joints, who had no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.
详细描述
This was a multicenter, prospective, observational study of adalimumab. Each participant enrolled when initiating adalimumab treatment and was to be followed up for 24 weeks or until discontinuation of the drug.
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 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •High disease activity, with poor prognostic factors (e.g., rheumatoid factor [RF]-positive, anti-cyclic citrullinated peptide [CCP] antibody-positive, or bone erosion)
- •Combination of adalimumab and methotrexate will be started
- •No prior history of treatment with disease-modifying anti-rheumatic drugs
- •No prior history of treatment with biological agents
- •Adalimumab dosed according to the registered product label
- •Signed informed consent
排除标准
- •There were no specific exclusion criteria.
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From baseline through week 26
An adverse event (AE) is defined as any untoward medical occurrence in a patient which does not necessarily have a causal relationship with their treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not the event is considered causally related to the use of the product. Adverse events were collected from the time of informed consent until the completion of the study, up to 26 weeks.
次要结局
- Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 12(at week 12)
- Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 24(at week 24)
- Mean Disease Activity Score 28 (DAS28-4(ESR)) at Baseline(at week 0)
- Mean Disease Activity Score 28 (DAS28-4(ESR)) at Week 4(at week 4)
- Percentage of Participants Achieving DAS28-4(ESR) Remission(From baseline to 24 weeks)
- Mean Clinical Disease Activity Index (CDAI) Score at Baseline(at week 0)
- Mean Clinical Disease Activity Index (CDAI) Score at Week 4(at week 4)
- Mean Clinical Disease Activity Index (CDAI) Score at Week 12(at week 12)
- Mean Clinical Disease Activity Index (CDAI) Score at Week 24(at week 24)
- Percentage of Participants Achieving CDAI Remission(From baseline to 24 weeks)
- Mean Simplified Disease Activity Index (SDAI) Score at Baseline(at week 0)
- Mean Simplified Disease Activity Index (SDAI) Score at Week 4(at week 4)
- Mean Simplified Disease Activity Index (SDAI) Score at Week 12(at week 12)
- Mean Simplified Disease Activity Index (SDAI) Score at Week 24(at week 24)
- Percentage of Participants Achieving SDAI Remission(From baseline to 24 weeks)