A Study Comparing Upadacitinib (ABT-494) to Placebo in Participants With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug



Status:Recruiting
Conditions:Arthritis, Psoriasis, Rheumatology
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:April 17, 2017
End Date:April 28, 2022
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

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A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)

This is a Phase 3 multicenter study that includes two periods. Period 1 is designed to
compare the safety, tolerability, and efficacy of ABT-494 Dose A once daily (QD) and Dose B
QD versus placebo in participants with moderately to severely active Psoriatic Arthritis
(PsA) who have an inadequate response to Biological Disease Modifying Anti-Rheumatic Drug
(bDMARDs). Period 2 evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and
Dose B QD in subjects with PsA who have completed Period 1.


Inclusion Criteria:

- Clinical diagnosis of PsA with symptom onset at least 6 months prior to the Screening
Visit and fulfillment of the Classification Criteria for PsA (CASPAR) criteria

- Participant has active disease at Baseline defined as >= 3 tender joints (based on 68
joint counts) and >= 3 swollen joints (based on 66 joint counts) at Screening and
Baseline Visits

- Diagnosis of active plaque psoriasis or documented history of plaque psoriasis

- Participant has had an inadequate response (lack of efficacy after a minimum 12 week
duration of therapy) or intolerance to treatment with at least 1 bDMARD.

Exclusion Criteria:

- Prior exposure to any Janus Kinase (JAK) inhibitor (including but not limited to
ruxolitinib, tofacitinib, baricitinib, and filgotinib)

- Current treatment with > 2 non-biologic DMARDs or use of DMARDs other than
Methotrexate (MTX), Sulfasalazine (SSZ), Leflunomide (LEF), apremilast,
Hydroxychloroquine (HCQ), bucillamine or iguratimod or use of MTX in combination with
LEF at Baseline.

- History of fibromyalgia, any arthritis with onset prior to age 17 years, or current
diagnosis of inflammatory joint disease other than PsA (including, but not limited to
rheumatoid arthritis, gout, overlap connective tissue diseases, scleroderma,
polymyositis, dermatomyositis, systemic lupus erythematosus). Prior history of
reactive arthritis or axial spondyloarthritis including ankylosing spondylitis and
non-radiographic axial spondyloarthritis is permitted if documentation of change in
diagnosis to PsA or additional diagnosis of PsA is made. Prior history of fibromyalgia
is permitted if documentation of change in diagnosis to PsA or documentation that the
diagnosis of fibromyalgia was made incorrectly.
We found this trial at
73
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6001 Airport Boulevard
Mobile, Alabama 36608
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Arlington, Virginia 22205
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4534 West Gate Boulevard
Austin, Texas 78745
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Aventura, Florida 33180
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8641 Wilshire Boulevard
Beverly Hills, California 90211
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10370 Park Road
Charlotte, North Carolina 28210
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Chicago, Illinois 60640
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Clearwater, Florida 33765
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College Station, Texas 77845
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Corpus Christi, Texas 78404
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Covina, California 91722
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Dallas, TX
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1 Elizabeth Place
Dayton, Ohio 45417
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1900 Mason Avenue
Daytona Beach, Florida 32117
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2712 North Decatur Road
Decatur, Georgia 30033
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200 Spruce Street
Denver, Colorado 80230
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Duncansville, Pennsylvania 16635
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300 South Pierce Street
El Cajon, California 92020
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71 Thomas Johnson Drive
Frederick, Maryland 21702
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Fullerton, California 92835
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1850 West Arlington Boulevard
Greenville, North Carolina 27834
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Hemet, CA
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2060 Space Park Drive
Houston, Texas 77034
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Huntington Beach, California 92648
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4707 Papermill Drive Northwest
Knoxville, Tennessee 37909
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8860 Center Drive
La Mesa, California 91942
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Las Cruces, New Mexico 88011
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607 South John Redditt Drive
Lufkin, Texas 75904
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Marietta, Georgia 30060
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Memphis, Tennessee 38119
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1600 Republic Parkway
Mesquite, Texas 75150
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Miami Lakes, Florida 33016
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400 East Burdick Expressway
Minot, North Dakota 58701
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3402 Magnolia Cove
Monroe, Louisiana 71203
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5604 Gulf Drive
New Port Richey, Florida 34652
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1211 North Shartel Avenue
Oklahoma City, Oklahoma 73103
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10170 Nicholas Street
Omaha, Nebraska 68114
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Ormond Beach, Florida 32174
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32615 US Highway 19 North
Palm Harbor, Florida 34684
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Pittsburgh, Pennsylvania 15260
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Potsdam, New York 13676
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Raleigh, North Carolina 27617
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Saint Petersburg, Florida 33705
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Sarasota, Florida 34239
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Seattle, Washington 98104
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4350 South National Avenue
Springfield, Missouri 65810
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Stanford, California 94305
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4612 North Habana Avenue
Tampa, Florida 33614
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13406 Medical Complex Drive
Tomball, Texas 77375
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Toms River, New Jersey 08755
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565 Lakeview Parkway
Vernon Hills, Illinois 60061
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Whittier, California 90602
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1907 Tradd Court
Wilmington, North Carolina 28401
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Worcester, Massachusetts 01610
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Zephyrhills, Florida 33542
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