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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01375127
Registration number
NCT01375127
Ethics application status
Date submitted
13/06/2011
Date registered
17/06/2011
Date last updated
29/10/2013
Titles & IDs
Public title
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
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Scientific title
An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies
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Secondary ID [1]
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A3921053
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation
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Condition category
Condition code
Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Tofacitinib
Subjects from Study A3921009 -
Subjects from Study A3921030 -
Treatment: Drugs: Tofacitinib
Subjects who previously took 15 mg BID or 30 mg BID
Treatment: Drugs: Tofacitinib
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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)
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Assessment method [1]
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All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
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Timepoint [1]
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Baseline through Month 12
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Primary outcome [2]
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Number of Participants With Central Nervous System (CNS) Infection
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Assessment method [2]
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Participants with CNS infection involving the brain or spinal cord, within 12 months after the last dose of tofacitinib were reported.
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Timepoint [2]
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Baseline through Month 12
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Primary outcome [3]
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Number of Participants With Graft Failure
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline through Month 12
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Primary outcome [4]
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Number of Participants Who Died
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Assessment method [4]
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Timepoint [4]
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Baseline through Month 12
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- No other subjects are eligible for this study
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
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Accrual to date
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Final
83
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Pfizer Investigational Site - Camperdown
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Recruitment hospital [2]
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Pfizer Investigational Site - Westmead
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Recruitment hospital [3]
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Pfizer Investigational Site - Adelaide
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Recruitment hospital [4]
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Pfizer Investigational Site - Clayton
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Recruitment hospital [5]
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Pfizer Investigational Site - Parkville
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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5000 - Adelaide
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Recruitment postcode(s) [4]
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3168 - Clayton
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment outside Australia
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United States of America
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California
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Colorado
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Florida
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Illinois
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Anderlecht
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Praha 4 - Krc
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Nantes Cedex 1
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Paris Cedex 15
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France
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Toulouse Cedex 9
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Germany
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Berlin
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Germany
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Rotterdam
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Oslo
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Barcelona
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01375127
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01375127
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