An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies
Overview
- Phase
- N/A
- Intervention
- Tofacitinib
- Conditions
- Kidney Transplantation
- Sponsor
- Pfizer
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- Number of Participants With Central Nervous System (CNS) Infection
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •No other subjects are eligible for this study
Arms & Interventions
Subjects from Study A3921009
Intervention: Tofacitinib
Subjects from Study A3921030
Intervention: Tofacitinib
Outcomes
Primary Outcomes
Number of Participants With Central Nervous System (CNS) Infection
Time Frame: 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)
Time Frame: Baseline through Month 12
All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
Number of Participants Who Died
Time Frame: Baseline through Month 12
Number of Participants With Graft Failure
Time Frame: 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.