An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Number of Participants With Central Nervous System (CNS) Infection
研究概览
简要总结
This is an observational study designed to collect follow-up clinical date on subjects who were treated with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or did not elect to enroll in long-term extension studies.
详细描述
Subjects are identified based on whether they received tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or who did not elect to enroll in long-term extension studies. Subjects are pre-identified
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects have discontinued tofacitinib prior to the planned treatment duration in 2 completed Phase 2 studies; or have not enrolled in long-term extension studies.
排除标准
- •No other subjects are eligible for this study
研究组 & 干预措施
Subjects from Study A3921030
干预措施: Tofacitinib (Drug)
Subjects from Study A3921009
干预措施: Tofacitinib (Drug)
结局指标
主要结局
Number of Participants With Central Nervous System (CNS) Infection
时间窗: Baseline through Month 12
Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.
Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)
时间窗: Baseline through Month 12
All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
Number of Participants Who Died
时间窗: Baseline through Month 12
Number of Participants With Graft Failure
时间窗: Baseline through Month 12
Graft failure which occurred within 12 months after the last dose of tofacitinib was reported. Graft failure was defined as graft nephrectomy, re-transplantation, or return to dialysis for greater than or equal to (\>=) 6 consecutive weeks.
次要结局
未报告次要终点