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

NCT ID: NCT01375127

Last Updated: 2013-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

83 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-08-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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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

Conditions

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Kidney Transplantation

Keywords

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Observational clinical follow-up data

Study Design

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Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects from Study A3921009

Tofacitinib

Intervention Type DRUG

Subjects who previously took 15 mg BID or 30 mg BID

Subjects from Study A3921030

Tofacitinib

Intervention Type DRUG

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

Interventions

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Tofacitinib

Subjects who previously took 15 mg BID or 30 mg BID

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

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Pfizer Investigational Site

Palo Alto, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Stanford, California, United States

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Aurora, Colorado, United States

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Tampa, Florida, United States

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Pfizer Investigational Site

Chicago, Illinois, United States

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Chicago, Illinois, United States

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Boston, Massachusetts, United States

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Springfiled, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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St Louis, Missouri, United States

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Livingston, New Jersey, United States

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New York, New York, United States

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Valhalla, New York, United States

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Chapel Hill, North Carolina, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Richmond, Virginia, United States

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Camperdown, New South Wales, Australia

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Westmead, New South Wales, Australia

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Adelaide, South Australia, Australia

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Clayton, Victoria, Australia

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Parkville, Victoria, Australia

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Anderlecht, , Belgium

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Porto Alegre, Rio Grande do Sul, Brazil

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São Paulo, São Paulo, Brazil

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Edmonton, Alberta, Canada

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Pfizer Investigational Site

Praha 4 - Krc, , Czechia

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Nantes, , France

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Paris, , France

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Toulouse, , France

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Berlin, , Germany

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Hamburg, , Germany

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Roma, , Italy

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Rotterdam, , Netherlands

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Oslo, , Norway

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Pfizer Investigational Site

Barcelona, Barcelona, Spain

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Pfizer Investigational Site

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Countries

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United States Australia Belgium Brazil Canada Czechia France Germany Italy Netherlands Norway Spain

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3921053&StudyName=Collection%20of%20follow-up%20data%20from%20CP-690%2C550-treated%20kidney%20transplant%20recipients

To obtain contact information for a study center near you, click here.

Other Identifiers

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A3921053

Identifier Type: -

Identifier Source: org_study_id