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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects from Study A3921009 |
| ||
| Subjects from Study A3921030 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tofacitinib | Drug | Subjects who previously took 15 mg BID or 30 mg BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) | All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported. | Baseline through Month 12 |
| 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. | Baseline through Month 12 |
| 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. | Baseline through Month 12 |
| Number of Participants Who Died | Baseline through Month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who received treatment with tofacitinib in 2 completed Phase 2 studies who either discontinued treatment prematurely or who did not elect to enroll in long-term extension studies.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Los Angeles | California | 90024 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Tofacitinib |
| Drug |
Subjects who previously took 15 mg BID for 3 months then 10 mg BID, or 15 mg BID for 6 months then 10 mg BID |
|
| Los Angeles |
| California |
| 90095 |
| United States |
| Pfizer Investigational Site | Palo Alto | California | 94304 | United States |
| Pfizer Investigational Site | San Francisco | California | 94115 | United States |
| Pfizer Investigational Site | San Francisco | California | 94143 | United States |
| Pfizer Investigational Site | Stanford | California | 94305 | United States |
| Pfizer Investigational Site | Aurora | Colorado | 80045 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33606 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60611 | United States |
| Pfizer Investigational Site | Chicago | Illinois | 60637 | United States |
| Pfizer Investigational Site | Boston | Massachusetts | 02215 | United States |
| Pfizer Investigational Site | Springfiled | Massachusetts | 01107 | United States |
| Pfizer Investigational Site | Ann Arbor | Michigan | 48109 | United States |
| Pfizer Investigational Site | Detroit | Michigan | 48202 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63110 | United States |
| Pfizer Investigational Site | Livingston | New Jersey | 07039 | United States |
| Pfizer Investigational Site | New York | New York | 10029 | United States |
| Pfizer Investigational Site | Valhalla | New York | 10595 | United States |
| Pfizer Investigational Site | Chapel Hill | North Carolina | 27599-7211 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75204 | United States |
| Pfizer Investigational Site | Dallas | Texas | 75246 | United States |
| Pfizer Investigational Site | Fort Worth | Texas | 76104 | United States |
| Pfizer Investigational Site | Richmond | Virginia | 23298 | United States |
| Pfizer Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| Pfizer Investigational Site | Westmead | New South Wales | 2145 | Australia |
| Pfizer Investigational Site | Adelaide | South Australia | 5000 | Australia |
| Pfizer Investigational Site | Clayton | Victoria | 3168 | Australia |
| Pfizer Investigational Site | Parkville | Victoria | 3050 | Australia |
| Pfizer Investigational Site | Anderlecht | 1070 | Belgium |
| Pfizer Investigational Site | Porto Alegre | Rio Grande do Sul | 90020-090 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | 04038-002 | Brazil |
| Pfizer Investigational Site | Edmonton | Alberta | T6G 2B7 | Canada |
| Pfizer Investigational Site | Praha 4 - Krc | 14021 | Czechia |
| Pfizer Investigational Site | Nantes | 44093 | France |
| Pfizer Investigational Site | Paris | 75743 | France |
| Pfizer Investigational Site | Toulouse | 31059 | France |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Hamburg | 20246 | Germany |
| Pfizer Investigational Site | Roma | 00168 | Italy |
| Pfizer Investigational Site | Rotterdam | 3015 GD | Netherlands |
| Pfizer Investigational Site | Oslo | 0027 | Norway |
| Pfizer Investigational Site | Barcelona | Barcelona | 08036 | Spain |
| Pfizer Investigational Site | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| FG004 | 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). |
| FG005 | 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). |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 | 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). |
| BG002 | 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). |
| BG003 | 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). |
| BG004 | 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). |
| BG005 | 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). |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety analysis included all eligible participants who had provided an informed consent for this study. | Posted | Number | participants | Baseline through Month 12 |
|
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| |||||||||||||||||||||||||||||||||||||||||
| 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. | Safety analysis included all eligible participants who had provided an informed consent for this study. | Posted | Number | participants | Baseline through Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| 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. | Safety analysis included all eligible participants who had provided an informed consent for this study. | Posted | Number | participants | Baseline through Month 12 |
| |||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Who Died | Safety analysis included all eligible participants who had provided an informed consent for this study. | Posted | Number | participants | Baseline through Month 12 |
|
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Data collection was limited to clinical outcome of PTLD, CNS infection, graft failure, or death. Clinical outcomes were to be reported as serious adverse event (SAE) if they met pre-defined SAE criteria and had causal relationship to tofacitinib. Non-SAEs were not planned to be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). | 0 | 1 | 0 | 0 | ||
| EG001 | 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). | 0 | 1 | 0 | 0 | ||
| EG002 | 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). | 0 | 40 | 0 | 0 | ||
| EG003 | 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). | 0 | 33 | 0 | 0 | ||
| EG004 | 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). | 0 | 5 | 0 | 0 | ||
| EG005 | 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). | 0 | 3 | 0 | 0 |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| C479163 | tofacitinib |
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| Male |
|
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
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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). |
| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
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| OG003 | 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). |
| OG004 | 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). |
| OG005 | 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). |
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