Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
NCT01375127
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- 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.
- No other subjects are eligible for this study
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Descriptive Information | ||||
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Brief Title | Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients | |||
Official 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 | |||
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 Type | Observational | |||
Study Design | Time Perspective: Retrospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | 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. | |||
Condition | Kidney Transplantation | |||
Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 83 | |||
Original Estimated Enrollment | 110 | |||
Actual Study Completion Date | July 2012 | |||
Actual Primary Completion Date | July 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Australia, Belgium, Brazil, Canada, Czech Republic, France, Germany, Italy, Netherlands, Norway, Spain, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01375127 | |||
Other Study ID Numbers | A3921053 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | September 2013 |