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

September 25, 2013 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD)
Time Frame: Baseline through Month 12
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
Time Frame: Baseline through Month 12
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
Time Frame: Baseline through Month 12
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
Time Frame: Baseline through Month 12
Baseline through Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 13, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 29, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • A3921053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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