Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01375127
Recruitment Status : Completed
First Posted : June 17, 2011
Results First Posted : August 14, 2013
Last Update Posted : October 29, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Kidney Transplantation 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

Layout table for study information
Study Type : Observational
Actual Enrollment : 83 participants
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
Study Start Date : August 2011
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Number of Participants Who Died [ Time Frame: Baseline through Month 12 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375127


Locations
Layout table for location information
United States, California
Pfizer Investigational Site
Los Angeles, California, United States, 90024
Pfizer Investigational Site
Los Angeles, California, United States, 90095
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
United States, Colorado
Pfizer Investigational Site
Aurora, Colorado, United States, 80045
United States, Florida
Pfizer Investigational Site
Tampa, Florida, United States, 33606
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
Pfizer Investigational Site
Chicago, Illinois, United States, 60637
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02215
Pfizer Investigational Site
Springfiled, Massachusetts, United States, 01107
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site
Detroit, Michigan, United States, 48202
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
United States, New Jersey
Pfizer Investigational Site
Livingston, New Jersey, United States, 07039
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
Valhalla, New York, United States, 10595
United States, North Carolina
Pfizer Investigational Site
Chapel Hill, North Carolina, United States, 27599-7211
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75204
Pfizer Investigational Site
Dallas, Texas, United States, 75246
Pfizer Investigational Site
Fort Worth, Texas, United States, 76104
United States, Virginia
Pfizer Investigational Site
Richmond, Virginia, United States, 23298
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Pfizer Investigational Site
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Pfizer Investigational Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Pfizer Investigational Site
Clayton, Victoria, Australia, 3168
Pfizer Investigational Site
Parkville, Victoria, Australia, 3050
Belgium
Pfizer Investigational Site
Anderlecht, Belgium, 1070
Brazil
Pfizer Investigational Site
Porto Alegre, RS, Brazil, 90020-090
Pfizer Investigational Site
Sao Paulo, SP, Brazil, 04038-002
Canada, Alberta
Pfizer Investigational Site
Edmonton, Alberta, Canada, T6G 2B7
Czech Republic
Pfizer Investigational Site
Praha 4 - Krc, Czech Republic, 14021
France
Pfizer Investigational Site
Nantes Cedex 1, France, 44093
Pfizer Investigational Site
Paris Cedex 15, France, 75743
Pfizer Investigational Site
Toulouse Cedex 9, France, 31059
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Hamburg, Germany, 20246
Italy
Pfizer Investigational Site
Roma, Italy, 00168
Netherlands
Pfizer Investigational Site
Rotterdam, Netherlands, 3015 GD
Norway
Pfizer Investigational Site
Oslo, Norway, 0027
Spain
Pfizer Investigational Site
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Pfizer Investigational Site
Barcelona, Spain, 08036
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01375127    
Other Study ID Numbers: A3921053
First Posted: June 17, 2011    Key Record Dates
Results First Posted: August 14, 2013
Last Update Posted: October 29, 2013
Last Verified: September 2013
Keywords provided by Pfizer:
Observational
clinical follow-up data
Additional relevant MeSH terms:
Layout table for MeSH terms
Tofacitinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action