Kidney Transplantation
Conditions
Keywords
Observational, clinical follow-up data
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
Interventions
DRUGTofacitinib
Subjects who previously took 15 mg BID or 30 mg BID
Sponsors
Pfizer
Study design
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| Number of Participants Who Died | Baseline through Month 12 | — |
Countries
Australia, Belgium, Brazil, Canada, Czechia, France, Germany, Italy, Netherlands, Norway, Spain, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 1 |
| 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). | 1 |
| 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). | 40 |
| 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). | 33 |
| 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). | 5 |
| 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). | 3 |
| Total | 83 |
Baseline characteristics
| Characteristic | Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) | Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) | Tofacitinib 15 mg (Study A3921030, Month 1 to 6) | Tofacitinib 15 mg (Study A3921030, Month 1 to 3) | Tofacitinib 15 mg (Study A3921009) | Tofacitinib 30 mg (Study A3921009) | Total |
|---|---|---|---|---|---|---|---|
| Age Continuous | 67.0 years | 26.0 years | 46.8 years STANDARD_DEVIATION 13.2 | 45.3 years STANDARD_DEVIATION 13.1 | 46.8 years STANDARD_DEVIATION 8.5 | 36.7 years STANDARD_DEVIATION 3.1 | 45.8 years STANDARD_DEVIATION 13 |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 7 Participants | 6 Participants | 4 Participants | 0 Participants | 17 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 33 Participants | 27 Participants | 1 Participants | 3 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 | 0 / 40 | 0 / 33 | 0 / 5 | 0 / 3 |
Outcome results
Primary
Number of Participants Who Died
Time frame: Baseline through Month 12
Population: Safety analysis included all eligible participants who had provided an informed consent for this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) | Number of Participants Who Died | 0 participants |
| Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) | Number of Participants Who Died | 0 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 6) | Number of Participants Who Died | 0 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 3) | Number of Participants Who Died | 0 participants |
| Tofacitinib 15 mg (Study A3921009) | Number of Participants Who Died | 0 participants |
| Tofacitinib 30 mg (Study A3921009) | Number of Participants Who Died | 0 participants |
Primary
Number of Participants With Central Nervous System (CNS) Infection
Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.
Time frame: Baseline through Month 12
Population: Safety analysis included all eligible participants who had provided an informed consent for this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) | Number of Participants With Central Nervous System (CNS) Infection | 0 participants |
| Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) | Number of Participants With Central Nervous System (CNS) Infection | 0 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 6) | Number of Participants With Central Nervous System (CNS) Infection | 0 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 3) | Number of Participants With Central Nervous System (CNS) Infection | 0 participants |
| Tofacitinib 15 mg (Study A3921009) | Number of Participants With Central Nervous System (CNS) Infection | 0 participants |
| Tofacitinib 30 mg (Study A3921009) | Number of Participants With Central Nervous System (CNS) Infection | 0 participants |
Primary
Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)
All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
Time frame: Baseline through Month 12
Population: Safety analysis included all eligible participants who had provided an informed consent for this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) | Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | 0 participants |
| Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) | Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | 0 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 6) | Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | 0 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 3) | Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | 0 participants |
| Tofacitinib 15 mg (Study A3921009) | Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | 0 participants |
| Tofacitinib 30 mg (Study A3921009) | Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | 0 participants |
Primary
Number of Participants With Graft Failure
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.
Time frame: Baseline through Month 12
Population: Safety analysis included all eligible participants who had provided an informed consent for this study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tofacitinib 10 mg (Pre-amendment 1, Study A3921030) | Number of Participants With Graft Failure | 0 participants |
| Tofacitinib 15 mg (Pre-amendment 1, Study A3921030) | Number of Participants With Graft Failure | 0 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 6) | Number of Participants With Graft Failure | 2 participants |
| Tofacitinib 15 mg (Study A3921030, Month 1 to 3) | Number of Participants With Graft Failure | 3 participants |
| Tofacitinib 15 mg (Study A3921009) | Number of Participants With Graft Failure | 0 participants |
| Tofacitinib 30 mg (Study A3921009) | Number of Participants With Graft Failure | 0 participants |