Effectiveness and Safety of Adalimumab in Rheumatoid Arthritis Patients in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5,745
- 试验地点
- 370
- 主要终点
- Percentage of Participants in DAS28 Remission
研究概览
简要总结
Observation of safety, tolerability and effectiveness of adalimumab (Humira) therapy in a large patient collective under everyday clinical conditions over a 5-year period.
详细描述
Patients with Rheumatoid Arthritis and started treatment with adalimumab in a normal clinical setting according to the label were documented. The follow-up observation period was for 5 years and focused on safety information and maintenance of efficacy during the normal clinical setting. Follow-up with participants was via regular office visits at intervals as determined by routine clinical practice or as recommended by national guidelines.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe active rheumatoid arthritis in adults with insufficient response to disease-modifying antirheumatic drugs, including methotrexate.
- •Moderate to severe active rheumatoid arthritis in adults who have not been treated with methotrexate before.
- •In case of incompatibility with methotrexate, adalimumab can be used as monotherapy
排除标准
- •Hypersensitivity against the drug or one of the other ingredients; active tuberculosis or other severe infections (e.g. sepsis and opportunistic infections); moderate to severe cardiac insufficiency
结局指标
主要结局
Percentage of Participants in DAS28 Remission
时间窗: Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
Clinical remission is defined as a DAS28 score of \< 2.6. The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity calculated from the 28 tender joint count, 28 swollen joint count, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (measured on a visual analog scale \[VAS\] from 0 to 10 cm). Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
Change From Baseline in Disease Activity Score (DAS) 28
时间窗: Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and general health (measured on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.
次要结局
- C-Reactive Protein (CRP) Levels Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Percentage of Participants With Low, Moderate and High Disease Activity(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Erythrocyte Sedimentation Rate (ESR) Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Swollen Joint Count (SJC) Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Percentage of Participants With a Significant Therapeutic Response(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Participants Assessment of Fatigue Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Percentage of Participants With Impairment in Daily Activities(Baseline and Months 6, 18, 24, and 30)
- Number of Days Missed From Work Due to Rheumatoid Arthritis(Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60)
- Tender Joint Count (TJC) Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Hannover Functional Questionnaire (FFbH) Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Participants Assessment of Pain Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Patients Global Assessment of Disease Activity Over Time(Baseline and Months 3, 6, 12, 18, 24, 30, 36, 48, and 60)
- Percentage of Participants With In-patient Hospitalization(Baseline and Months 6, 12, 18, 24, 30, 36, 48, and 60)