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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01375127




Registration number
NCT01375127
Ethics application status
Date submitted
13/06/2011
Date registered
17/06/2011
Date last updated
29/10/2013

Titles & IDs
Public title
Collection of Follow-up Data From CP-690,550-treated Kidney Transplant Recipients
Scientific 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
Secondary ID [1] 0 0
A3921053
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Kidney Transplantation 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Tofacitinib
Treatment: Drugs - Tofacitinib

Subjects from Study A3921009 -

Subjects from Study A3921030 -


Treatment: Drugs: Tofacitinib
Subjects who previously took 15 mg BID or 30 mg BID

Treatment: Drugs: 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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Outcome of Post Transplant Lymphoproliferative Disease (PTLD) - All lymphoproliferative disorders diagnosed locally as PTLD based on histopathology were reported.
Timepoint [1] 0 0
Baseline through Month 12
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline through Month 12
Primary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline through Month 12
Primary outcome [4] 0 0
Number of Participants Who Died
Timepoint [4] 0 0
Baseline through Month 12

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- No other subjects are eligible for this study

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Westmead
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Adelaide
Recruitment hospital [4] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [5] 0 0
Pfizer Investigational Site - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Massachusetts
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Missouri
Country [8] 0 0
United States of America
State/province [8] 0 0
New Jersey
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
Country [13] 0 0
Belgium
State/province [13] 0 0
Anderlecht
Country [14] 0 0
Brazil
State/province [14] 0 0
RS
Country [15] 0 0
Brazil
State/province [15] 0 0
SP
Country [16] 0 0
Canada
State/province [16] 0 0
Alberta
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Praha 4 - Krc
Country [18] 0 0
France
State/province [18] 0 0
Nantes Cedex 1
Country [19] 0 0
France
State/province [19] 0 0
Paris Cedex 15
Country [20] 0 0
France
State/province [20] 0 0
Toulouse Cedex 9
Country [21] 0 0
Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Hamburg
Country [23] 0 0
Italy
State/province [23] 0 0
Roma
Country [24] 0 0
Netherlands
State/province [24] 0 0
Rotterdam
Country [25] 0 0
Norway
State/province [25] 0 0
Oslo
Country [26] 0 0
Spain
State/province [26] 0 0
Barcelona

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01375127
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications