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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01375127
First received: June 13, 2011
Last updated: September 25, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Kidney Transplantation
Drug: Tofacitinib

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: Yes ]
    All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.

  • Number of Participants With Central Nervous System (CNS) Infection [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline through Month 12 ] [ Designated as safety issue: Yes ]

Enrollment: 83
Study Start Date: August 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects from Study A3921009 Drug: Tofacitinib
Subjects who previously took 15 mg BID or 30 mg BID
Subjects from Study A3921030 Drug: 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

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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01375127

  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01375127     History of Changes
Other Study ID Numbers: A3921053
Study First Received: June 13, 2011
Results First Received: May 17, 2013
Last Updated: September 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Observational
clinical follow-up data

Additional relevant MeSH terms:
Tofacitinib
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on October 21, 2014