Trial Outcomes & Findings for Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients (NCT NCT01375127)

Results Overview

All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.

Recruitment status

COMPLETED

Target enrollment

83 participants

Primary outcome timeframe

Baseline through Month 12

Results posted on

2013-10-29

Participant Flow

Participants who discontinued tofacitinib prior to the end of the planned treatment duration, or did not enroll in long-term extension studies after completing tofacitinib treatment in Phase 2a study A3921009 (NCT00106639) and Phase 2b study A3921030 (NCT00483756) were enrolled in this study.

Participant milestones

Participant milestones
Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921009) Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 30 mg (Study A3921009) Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
Overall Study STARTED	1	1	40	33	5	3
Overall Study COMPLETED	1	1	40	33	5	3
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n=40 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n=33 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921009) n=5 Participants Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 30 mg (Study A3921009) n=3 Participants Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Total n=83 Participants Total of all reporting groups
Age Continuous	67.0 years n=5 Participants	26.0 years n=7 Participants	46.8 years STANDARD_DEVIATION 13.2 • n=5 Participants	45.3 years STANDARD_DEVIATION 13.1 • n=4 Participants	46.8 years STANDARD_DEVIATION 8.5 • n=21 Participants	36.7 years STANDARD_DEVIATION 3.1 • n=8 Participants	45.8 years STANDARD_DEVIATION 13.0 • n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	7 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=8 Participants	17 Participants n=8 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	33 Participants n=5 Participants	27 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	66 Participants n=8 Participants

PRIMARY outcome

Timeframe: Baseline through Month 12

Population: Safety analysis included all eligible participants who had provided an informed consent for this study.

All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n=40 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n=33 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921009) n=5 Participants Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 30 mg (Study A3921009) n=3 Participants Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline through Month 12

Population: Safety analysis included all eligible participants who had provided an informed consent for this study.

Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n=40 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n=33 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921009) n=5 Participants Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 30 mg (Study A3921009) n=3 Participants Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
Number of Participants With Central Nervous System (CNS) Infection	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline through Month 12

Population: Safety analysis included all eligible participants who had provided an informed consent for this study.

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.

Outcome measures

Outcome measures
Measure	Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).	Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) n=1 Participants Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 6) n=40 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921030, Month 1 to 3) n=33 Participants Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 15 mg (Study A3921009) n=5 Participants Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).	Tofacitinib 30 mg (Study A3921009) n=3 Participants Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
Number of Participants With Graft Failure	0 participants	0 participants	2 participants	3 participants	0 participants	0 participants

PRIMARY outcome

Timeframe: Baseline through Month 12

Population: Safety analysis included all eligible participants who had provided an informed consent for this study.