Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Tofacitinib

• Registration Number: NCT01375127
• Lead Sponsor: Pfizer

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

Study Timeline

• Study First Submitted: 2011-06-13
• Study First Submitted QC: 2011-06-16
• Study First Posted: 2011-06-17
• Study Start: 2011-08
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-05-17
• Results First Submitted QC: 2013-05-17
• Results First Posted: 2013-08-14
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-25
• Last Update Posted: 2013-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects from Study A3921009	Tofacitinib	-
Subjects from Study A3921030	Tofacitinib	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Central Nervous System (CNS) Infection	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)	Baseline through Month 12	All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
Number of Participants Who Died	Baseline through Month 12
Number of Participants With Graft Failure	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇪🇸 Barcelona, Spain