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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01375127
Other study ID # A3921053
Secondary ID
Status Completed
Phase N/A
First received June 13, 2011
Last updated September 25, 2013
Start date August 2011
Est. completion date July 2012

Study information

Verified date September 2013
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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 Design

Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Drug:
Tofacitinib
Subjects who previously took 15 mg BID or 30 mg BID
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

Locations

Country Name City State
Australia Pfizer Investigational Site Adelaide South Australia
Australia Pfizer Investigational Site Camperdown New South Wales
Australia Pfizer Investigational Site Clayton Victoria
Australia Pfizer Investigational Site Parkville Victoria
Australia Pfizer Investigational Site Westmead New South Wales
Belgium Pfizer Investigational Site Anderlecht
Brazil Pfizer Investigational Site Porto Alegre RS
Brazil Pfizer Investigational Site Sao Paulo SP
Canada Pfizer Investigational Site Edmonton Alberta
Czech Republic Pfizer Investigational Site Praha 4 - Krc
France Pfizer Investigational Site Nantes Cedex 1
France Pfizer Investigational Site Paris Cedex 15
France Pfizer Investigational Site Toulouse Cedex 9
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Hamburg
Italy Pfizer Investigational Site Roma
Netherlands Pfizer Investigational Site Rotterdam
Norway Pfizer Investigational Site Oslo
Spain Pfizer Investigational Site Barcelona
Spain Pfizer Investigational Site L'Hospitalet de Llobregat Barcelona
United States Pfizer Investigational Site Ann Arbor Michigan
United States Pfizer Investigational Site Aurora Colorado
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Chapel Hill North Carolina
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Dallas Texas
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Livingston New Jersey
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site Los Angeles California
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Palo Alto California
United States Pfizer Investigational Site Richmond Virginia
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site San Francisco California
United States Pfizer Investigational Site Springfiled Massachusetts
United States Pfizer Investigational Site St. Louis Missouri
United States Pfizer Investigational Site Stanford California
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Valhalla New York

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Canada,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Norway,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary 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 Yes
Primary 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 Yes
Primary Number of Participants Who Died Baseline through Month 12 Yes
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