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:3/24/2019
Start Date:February 17, 2014
End Date:July 11, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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
Rheumatology Associates of Central Florida
Orlando, Florida 32806
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Orlando, FL
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Brigham and Women's Hosp
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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East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania 18015
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Bethlehem, PA
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Rheumatology Associates, PC
Birmingham, Alabama 35205
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Birmingham, AL
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St. Luke's Intermountain Research Center
Boise, Idaho 83702
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Boise, ID
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St. Luke's Clinic - Rheumatology
Boise, Idaho 83702
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Boise, ID
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New England Research Associates, LLC
4641 Main Street
Bridgeport, Connecticut 06606
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Bridgeport, CT
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Royal Prince Alfred Hospital
Camperdown, New South Wales 2050
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Camperdown,
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Cincinnati Rheumatic Disease Study Group
Cincinnati, Ohio 45219
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Cincinnati, OH
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University Hospitals of Cleveland Medical Center
Cleveland, Ohio 44012
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Cleveland, OH
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University Hospitals Cleveland Medical Center IP ONLY
Cleveland, Ohio 44106
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Cleveland, OH
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Adriana Pop-Moody MD - Clinic PA
Corpus Christi, Texas 78404
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Corpus Christi, TX
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Pioneer Research Solutions
Cypress, Texas 77429
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Cypress, TX
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Altoona Center for Clinical Research
Duncansville, Pennsylvania 16635
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Duncansville, PA
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St. Paul Rheumatology, PA
Eagan, Minnesota 55121
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Eagan, MN
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St. Jude Hospital Yorba Linda DBA St. Joseph Heritage Healthcare
Fullerton, California 92835
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Fullerton, CA
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Arizona Arthritis & Rheumatology Associates, PC
Glendale, Arizona 85304
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Glendale, AZ
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Klein & Associates MD, PA.
Hagerstown, Maryland 21740
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Hagerstown, MD
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Rheumatology Associates Of North Alabama, P.C.
Huntsville, Alabama 35801
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Huntsville, AL
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The Arthritis Clinic
Jackson, Tennessee 38305
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Jackson, TN
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West Tennessee Research Institute
Jackson, Tennessee 38305
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Jackson, TN
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Dartmouth Hitchcock Medical Center
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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Bluegrass Community Research, Inc
Lexington, Kentucky 40504
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Lexington, KY
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Physician Research Collaboration
Lincoln, Nebraska 68512
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Lincoln, NE
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Paramount Medical Research & Consulting, Llc
Middleburg Heights, Ohio 44130
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Middleburg Heights, OH
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Millennium Research
Ormond Beach, Florida 32174
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Ormond Beach, FL
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Desert Medical Advances
Palm Desert, California 92260
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Palm Desert, CA
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Arthritis Center, Inc.
32615 US Highway 19 North
Palm Harbour, Florida 34684
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Palm Harbour, FL
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Integral Rheumatology & Immunology Specialists (IRIS)
Plantation, Florida 33324
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Plantation, FL
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Integral Rheumatology & Immunology Specialists
Plantation, Florida 33324
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Plantation, FL
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Clayton Medical Research
Saint Louis, Missouri 63117
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Saint Louis, MO
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University of Utah Hospital and Clinics
Salt Lake City, Utah 84132
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Salt Lake City, UT
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Investigational Drug Services
Salt Lake City, Utah 84112
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Salt Lake City, UT
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San Diego Arthritis Medical Clinic
San Diego, California 92108
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San Diego, CA
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Seattle Rheumatology Associates
Seattle, Washington 98104
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Seattle, WA
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Swedish Medical Center
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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Seattle, WA
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Stanford Hospital and Clinics
Stanford, California 94305
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Stanford, CA
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Articularis Healtchare Group, Inc. d/b/a Low Country Rheumatology
Summerville, South Carolina 29486
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Summerville, SC
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Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology
Summerville, South Carolina 29486
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Summerville, SC
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The Center for Rheumatology and Bone Research
Wheaton, Maryland 20902
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Wheaton, MD
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Clinical Pharmacology Study Group
Worcester, Massachusetts 01610
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Worcester, MA
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Florida Medical Clinic
Zephyrhills, Florida 33542
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Zephyrhills, FL
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