Effectiveness and Safety of Adalimumab in Patients With Rheumatoid Arthritis 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
- 4,208
- 试验地点
- 303
- 主要终点
- Change From Baseline in Disease Activity Score (DAS) 28
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 2 years.
详细描述
Patients with rheumatoid arthritis who started treatment with adalimumab in a normal clinical setting according to the product label were documented. The follow-up observation period was for 2 years and focused on safety information and maintenance of efficacy during a 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, Humira 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
Change From Baseline in Disease Activity Score (DAS) 28
时间窗: Baseline and Months 3, 6, 9, 12, 18, and 24
The Disease Activity Score 28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR), and the patient's assessment of global disease activity (on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28 score. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity. 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.
Percentage of Participants in DAS28 Remission
时间窗: Months 3, 6, 9, 12, 18, and 24
Clinical remission is defined as a disease activity score (DAS) 28 score of \< 2.6. 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 the patient's assessment of global disease activity (assessed on a visual analog scale \[VAS\] from 0 to 10 cm) are included in the DAS28. If the ESR value is missing, the C-reactive protein (CRP) value can be substituted. Scores on the DAS28 range from 0 to 10; higher scores indicate more disease activity.
次要结局
- Patients Global Assessment of Disease Activity Over Time(Baseline and Months 3, 6, 9, 12, 18 and 24)
- Participants Assessment of Fatigue Over Time(Baseline and Month 3, 6, 9, 12, 18, and 24)
- Percentage of Participants With a Significant Therapeutic Response(Baseline and Months 3, 6, 9, 12, 18, and 24)
- Percentage of Participants With Low, Moderate and High Disease Activity(Baseline and Months 3, 6, 9, 12, 18, and 24)
- Erythrocyte Sedimentation Rate (ESR) Over Time(Baseline and Months 3, 6, 9, 12, 18, and 24)
- C-Reactive Protein (CRP) Levels Over Time(Baseline and Months 3, 6, 9, 12, 18, and 24)
- Tender Joint Count (TJC) Over Time(Baseline and Months 3, 6, 9, 12, 18, and 24)
- Swollen Joint Count (SJC) Over Time(Baseline and Months 3, 6, 9, 12, 18, and 24)
- Hannover Functional Questionnaire (FFbH) Over Time(Baseline and Months 3, 6, 9, 12, 18, and 24)
- Participants Assessment of Pain Over Time(Baseline and Months 3, 6, 9, 12, 18, and 24)
- Percentage of Participants With Impairment in Daily Activities(Baseline and Months 3, 6, 9, 18, and 24)
- Number of Days Missed From Work Due to Rheumatoid Arthritis(Baseline and Months 6, 12, 18, and 24)
- Percentage of Participants With In-patient Hospitalization(Month 6, 12, 18, and 24)
- Percentage of Participants on Concomitant Rheumatoid Arthritis and Pain Relief/Anti-inflammatory Medication(Baseline and Months 3, 6, 9, 12, 18, and 24)