Humira® for Subcutaneous Injection Special Investigation ( All-case Survey ) in Patients With Juvenile Idiopathic Arthritis Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 375
- 主要终点
- Change From Baseline in DAS28-4/ESR at Week 12
研究概览
简要总结
This study of Humira will be conducted to clarify the following with regard to the treatment of juvenile idiopathic arthritis affecting multiple joints with this drug:
- Unknown adverse drug reactions (especially important adverse drug reactions)
- Incidence and conditions of occurrence of adverse reactions in the clinical setting
- Factors that may affect the safety and effectiveness of Humira
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
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with Juvenile idiopathic arthritis who are not responding well to conventional therapy and receive Humira will be enrolled in the survey
排除标准
- •Contraindications according to the Package Insert
- •Patients who have serious infections
- •Patients who have tuberculosis
- •Patients with a history of hypersensitivity to any ingredient of Humira
- •Patients who have demyelinating disease or with a history of demyelinating disease
- •Patients who have congestive cardiac failure
结局指标
主要结局
Change From Baseline in DAS28-4/ESR at Week 12
时间窗: Baseline, Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/ESR at Week 4
时间窗: Baseline, Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/ESR at Week 8
时间窗: Baseline, Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/ESR at Week 16
时间窗: Baseline, Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/ESR at Week 24
时间窗: Baseline, Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, ESR, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/CRP at Week 4
时间窗: Baseline, Week 4
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/CRP at Week 8
时间窗: Baseline, Week 8
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/CRP at Week 12
时间窗: Baseline, Week 12
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/CRP at Week 16
时间窗: Baseline, Week 16
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in DAS28-4/CRP at Week 24
时间窗: Baseline, Week 24
The DAS28 is a validated index of arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, CRP, and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a Likert scale from 0 \[low activity\] to 10 \[high activity\]) 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.
Change From Baseline in Serum MMP3 Level at Week 4
时间窗: Baseline, Week 4
Change From Baseline in Serum MMP3 Level at Week 8
时间窗: Baseline, Week 8
Change From Baseline in Serum MMP3 Level at Week 12
时间窗: Baseline, Week 12
Change From Baseline in Serum MMP3 Level at Week 16
时间窗: Baseline, Week 16
Change From Baseline in Serum MMP3 Level at Week 24
时间窗: Baseline, Week 24
Change From Baseline in Physician Global Assessment (VAS) at Week 4
时间窗: Baseline, Week 4
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 8
时间窗: Baseline, Week 8
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 12
时间窗: Baseline, Week 12
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 16
时间窗: Baseline, Week 16
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Physician Global Assessment (VAS) at Week 24
时间窗: Baseline, Week 24
A VAS was used for the Physician Global Assessment of disease activity (current status). The left end of the VAS scale (0 mm) signifies the absence of symptoms and the right end (100 mm) signifies maximum disease activity. A negative change from baseline indicates improvement.
Change From Baseline in Anti-Cyclic Citrullinated Peptide Antibodies at Week 24
时间窗: Baseline, Week 24
Change From Baseline in Height at Week 4
时间窗: Baseline, Week 4
Change From Baseline in Height at Week 8
时间窗: Baseline, Week 8
Change From Baseline in Height at Week 12
时间窗: Baseline, Week 12
Change From Baseline in Height at Week 16
时间窗: Baseline, Week 16
Change From Baseline in Height at Week 24
时间窗: Baseline, Week 24
Change From Baseline in Weight at Week 4
时间窗: Baseline, Week 4
Change From Baseline in Weight at Week 8
时间窗: Baseline, Week 8
Change From Baseline in Weight at Week 12
时间窗: Baseline, Week 12
Change From Baseline in Weight at Week 16
时间窗: Baseline, Week 16
Change From Baseline in Weight at Week 24
时间窗: Baseline, Week 24
次要结局
未报告次要终点