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

An Observational Study To Collect Follow-up Clinical Data From Kidney Transplant Recipients Who Received Tofacitinib (CP-690,550) In Completed Phase 2 Studies

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.

Study Overview

• Status: Completed
• Conditions: Kidney Transplantation
• Intervention / Treatment: Drug: Tofacitinib; Drug: Tofacitinib

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
• Enrollment (Actual): 83

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Pfizer Investigational Site
    • Westmead, New South Wales, Australia, 2145
      • Pfizer Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Pfizer Investigational Site
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Pfizer Investigational Site
    • Parkville, Victoria, Australia, 3050
      • Pfizer Investigational Site
• Belgium
  • Anderlecht, Belgium, 1070
    • Pfizer Investigational Site
• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90020-090
      • Pfizer Investigational Site
  • SP
    • Sao Paulo, SP, Brazil, 04038-002
      • Pfizer Investigational Site
• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2B7
      • Pfizer Investigational Site
• Czech Republic
  • Praha 4 - Krc, Czech Republic, 14021
    • Pfizer Investigational Site
• France
  • Nantes Cedex 1, France, 44093
    • Pfizer Investigational Site
  • Paris Cedex 15, France, 75743
    • Pfizer Investigational Site
  • Toulouse Cedex 9, France, 31059
    • Pfizer Investigational Site
• Germany
  • Berlin, Germany, 10117
    • Pfizer Investigational Site
  • Hamburg, Germany, 20246
    • Pfizer Investigational Site
• Italy
  • Roma, Italy, 00168
    • Pfizer Investigational Site
• Netherlands
  • Rotterdam, Netherlands, 3015 GD
    • Pfizer Investigational Site
• Norway
  • Oslo, Norway, 0027
    • Pfizer Investigational Site
• Spain
  • Barcelona, Spain, 08036
    • Pfizer Investigational Site
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Pfizer Investigational Site
• United States
  • California
    • Los Angeles, California, United States, 90095
      • Pfizer Investigational Site
    • Los Angeles, California, United States, 90024
      • Pfizer Investigational Site
    • Palo Alto, California, United States, 94304
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94115
      • Pfizer Investigational Site
    • San Francisco, California, United States, 94143
      • Pfizer Investigational Site
    • Stanford, California, United States, 94305
      • Pfizer Investigational Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Pfizer Investigational Site
  • Florida
    • Tampa, Florida, United States, 33606
      • Pfizer Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60637
      • Pfizer Investigational Site
    • Chicago, Illinois, United States, 60611
      • Pfizer Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Pfizer Investigational Site
    • Springfiled, Massachusetts, United States, 01107
      • Pfizer Investigational Site
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Pfizer Investigational Site
    • Detroit, Michigan, United States, 48202
      • Pfizer Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63110
      • Pfizer Investigational Site
  • New Jersey
    • Livingston, New Jersey, United States, 07039
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10029
      • Pfizer Investigational Site
    • Valhalla, New York, United States, 10595
      • Pfizer Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599-7211
      • Pfizer Investigational Site
  • Texas
    • Dallas, Texas, United States, 75204
      • Pfizer Investigational Site
    • Dallas, Texas, United States, 75246
      • Pfizer Investigational Site
    • Fort Worth, Texas, United States, 76104
      • Pfizer Investigational Site
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Subjects from Study A3921009	Drug: Tofacitinib; Subjects who previously took 15 mg BID or 30 mg BID; 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
Subjects from Study A3921030	Drug: Tofacitinib; Subjects who previously took 15 mg BID or 30 mg BID; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: June 13, 2011
• First Submitted That Met QC Criteria: June 16, 2011
• First Posted (Estimate): June 17, 2011

Study Record Updates

• Last Update Posted (Estimate): October 29, 2013
• Last Update Submitted That Met QC Criteria: September 25, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Observational; clinical follow-up data
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: A3921053