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
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

ClinicalTrials.gov processed this record on April 15, 2014