Open-Label Extension Study Of Tofacitinib In Psoriatic Arthritis



Status:Active, not recruiting
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:2/7/2019
Start Date:February 17, 2014
End Date:July 11, 2019

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A LONG-TERM, OPEN-LABEL EXTENSION STUDY OF TOFACITINIB (CP-690,550) FOR THE TREATMENT OF PSORIATIC ARTHRITIS

This is a Phase 3, long-term open-label extension study to evaluate the safety, tolerability
and efficacy of tofacitinib in subjects with active PsA who have previously participated in
randomized studies of tofacitinib for this indication.

This study will include a sub-study to evaluate the efficacy, safety and tolerability of
tofacitinib 5 mg BID administered as monotherapy after methotrexate withdrawal compared to
tofacitinib 5 mg BID continued in combination with methotrexate. The sub-study will be
available to subjects who have completed at least 24 months of participation in the
open-label extension study and meet eligibility criteria for the sub-study.


Inclusion Criteria:

- Previous participation in qualifying PsA study involving tofacitinib

Exclusion Criteria:

- Time from End of Study visit of qualifying study is >3 months.

- Pregnant female, breastfeeding female or female of childbearing potential unwilling or
unable to use highly effective birth control for duration of study and one ovulatory
cycle thereafter.

Sub-study Inclusion Criteria:

- Subjects who have completed at least 24 months of treatment with tofacitinib in the
extension study

- Subjects on a stable oral dose of methotrexate (maximum dose 20 mg per week)

Sub-study Exclusion Criteria:

-Subjects who are receiving methotrexate by a route other than oral
We found this trial at
42
sites
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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Lebanon, NH
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Boston, MA
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Bethlehem, Pennsylvania 18015
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Birmingham, Alabama 35205
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Boise, ID
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4641 Main Street
Bridgeport, Connecticut 06606
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Camperdown, New South Wales 2050
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Cincinnati, OH
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Cleveland, OH
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Corpus Christi, Texas 78404
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Cypress, Texas 77429
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Duncansville, Pennsylvania 16635
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Eagan, Minnesota 55121
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Fullerton, CA
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Glendale, AZ
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Hagerstown, Maryland 21740
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Jackson, Tennessee 38305
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Jackson, Tennessee 38305
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Lexington, Kentucky 40504
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Lincoln, Nebraska 68512
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Middleburg Heights, Ohio 44130
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Ormond Beach, Florida 32174
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Palm Desert, California 92260
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32615 US Highway 19 North
Palm Harbour, Florida 34684
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Saint Louis, Missouri 63117
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Salt Lake City, Utah 84132
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Salt Lake City, Utah 84112
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San Diego, California 92108
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Seattle, Washington 98104
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Stanford, California 94305
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Summerville, SC
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Worcester, Massachusetts 01610
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Zephyrhills, Florida 33542
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