XELJANZ (REGISTERED) TABLETS 5MG SPECIAL INVESTIGATION (ALL-CASES SURVEILLANCE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 9,968
- 主要终点
- Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ
研究概览
简要总结
The objective of this Surveillance is to verify the following subject matters concerning Tofacitinib (Xeljanz) under general practice.
- Occurrence of adverse reactions, factors that may potentially affect safety and efficacy 2） Long-term safety (particularly, malignant tumors and serious infections) and efficacy
Occurrences of malignant tumors and serious infections will be compared with a control group.
详细描述
All the patients whom an investigator prescribes the Xeljanz or Standard of Care for rheumatoid arthritis should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.
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
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients receiving Tofacitinib (Xeljanz)
排除标准
- •Not Applicable
研究组 & 干预措施
Tofacitinib (Xeljanz)
Tablets 5 mg BID
干预措施: Tofacitinib (Xeljanz) (Drug)
Standard of Care
Standard of Care for Rheumatoid Arthritis
干预措施: Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-related Adverse Events or Serious Treatment-related Adverse Events in Participants Who Received XELJANZ
时间窗: 36 months
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to XELJANZ in a participant who received XELJANZ. A serious adverse event/adverse drug reaction (SADR) was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to XELJANZ was assessed by the physician.
Change in Disease Activity Based on Simplified Disease Activity Index (SDAI)
时间窗: Baseline, 1, 6, 12, 24, 36 months
The SDAI is the numerical sum of five outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, patient global assessment (PtGA) and physician global assessment (PGA) assessed on 0-10 cm VAS, and C-reactive protein (CRP) (mg/dL). SDAI is defined as follows: ≤3.3, disease remission; \>3.3 to ≤11, low disease activity, \>11 to ≤26, moderate disease activity; and \>26, high disease activity. SDAI was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.
Change in Disease Activity Score Based on 28-joints Count (DAS28)
时间窗: Baseline, 1, 6, 12, 24, 36 months
DAS28 is the numerical sum of 4 outcome parameters: tender joint count (TJC) and swollen joint count (SJC) based on a 28-joint assessment, PtGA assessed on 0-10 cm VAS, and the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]). DAS28 is defined as follows: \<2.6, disease remission; ≥2.6 to \<3.2, low disease activity, ≥3.2 to ≤5.1, moderate disease activity; and \>5.1, high disease activity. DAS28 was assessed at each evaluation time point and mean change from the start of XELJANZ was calculated with the 95% CI.
次要结局
- Occurrence of Serious Infection Events(12 months)
- Occurrence of Malignancy(36 months)
- Occurrence of Death(36 months)