A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Participants With Psoriatic Arthritis Who Have an Inadequate Response to at Least One Non-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:4/4/2019
Start Date:April 27, 2017
End Date:August 24, 2022
Contact:ABBVIE CALL CENTER
Email:abbvieclinicaltrials@abbvie.com
Phone:847.283.8955

Use our guide to learn which trials are right for you!

A Phase 3, Randomized, Double-Blind, Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Active Psoriatic Arthritis Who Have a History of Inadequate Response to at Least One Non-Biologic Disease Modifying Anti-Rheumatic Drug (DMARD) - SELECT - PsA 1

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 and versus adalimumab every other week (eow) in participants with
moderately to severely active Psoriatic Arthritis (PsA) and have an inadequate response to
non-biologic DMARDs (DMARD-IR). Period 1 is also designed to compare the efficacy of ABT-494
Dose A QD and Dose B QD versus placebo for the prevention of structural progression. Period 2
evaluates the safety, tolerability and efficacy of ABT-494 Dose A QD and Dose B QD in
participants 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.

- Presence of either at Screening:

1. >= 1 erosion on x-ray as determined by central imaging review or;

2. hs-CRP > laboratory defined upper limit of normal (ULN).

- 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) to previous or current treatment with at least 1 non-biologic
DMARD at maximally tolerated dose (MTX, SSZ, LEF, apremilast, bucillamin, cyclosporine
or iguratimod), or participant has an intolerance to or contraindication for DMARDs as
defined by the investigator.

- Participant who is on current treatment with concomitant non-biologic DMARDs at study
entry must be on <= 2 non-biologic DMARDs (except the combination of MTX and
leflunomide). The following non-biologic DMARDs are allowed: MTX, sulfasalazine,
leflunomide, apremilast, HCQ , bucillamine or iguratimod, and have been ongoing for >=
12 weeks and at stable dose for >= 4 weeks prior to the Baseline Visit. No other
DMARDs are permitted during the study.

i. Participants who need to discontinue DMARDs prior to the Baseline Visit to comply
with this inclusion criterion must follow the procedure specified below or at least
five times the mean terminal elimination half-life of a drug:

1. >= 8 weeks for LEF if no elimination procedure was followed, or adhere to an
elimination procedure (i.e., 11 days with cholestyramine, or 30 days washout with
activated charcoal or as per local label);

2. >= 4 weeks for all others.

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, sulfasalazine, leflunomide, apremilast, hydroxychloroquine, bucillamine,
or iguratimod; or use of methotrexate in combination with leflunomide.

- 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
nonradiographic 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
118
sites
4202 East Fowler Avenue
Tampa, Florida 33612
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Arlington, Virginia 22205
?
mi
from
Arlington, VA
Click here to add this to my saved trials
Baltimore, Maryland 21224
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Baytown, TX
Click here to add this to my saved trials
?
mi
from
Beaumont, TX
Click here to add this to my saved trials
Boston, Massachusetts 02111
?
mi
from
Boston, MA
Click here to add this to my saved trials
Boston, Massachusetts 02114
?
mi
from
Boston, MA
Click here to add this to my saved trials
350 Park Street
Bowling Green, Kentucky 42101
?
mi
from
Bowling Green, KY
Click here to add this to my saved trials
?
mi
from
Buenos Aires,
Click here to add this to my saved trials
1918 Randolph Road
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
10370 Park Road
Charlotte, North Carolina 28210
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Chesapeake, Virginia 23320
?
mi
from
Chesapeake, VA
Click here to add this to my saved trials
Chicago, Illinois 60640
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Clearwater, Florida 33765
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
2500 Metrohealth Drive
Cleveland, Ohio 44109
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
College Station, Texas 77845
?
mi
from
College Station, TX
Click here to add this to my saved trials
Colleyville, Texas 76034
?
mi
from
Colleyville, TX
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Corpus Christi, Texas 78404
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
Covina, California 91722
?
mi
from
Covina, CA
Click here to add this to my saved trials
Cumberland, Maryland 21502
?
mi
from
Cumberland, MD
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
1 Elizabeth Place
Dayton, Ohio 45417
?
mi
from
Dayton, OH
Click here to add this to my saved trials
1900 Mason Avenue
Daytona Beach, Florida 32117
?
mi
from
Daytona Beach, FL
Click here to add this to my saved trials
609 North Charles Richard Beall Boulevard
DeBary, Florida 32713
?
mi
from
DeBary, FL
Click here to add this to my saved trials
200 Spruce Street
Denver, Colorado 80230
?
mi
from
Denver, CO
Click here to add this to my saved trials
915 East 1st Street
Duluth, Minnesota 55805
?
mi
from
Duluth, MN
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
Durham, North Carolina 27704
?
mi
from
Durham, NC
Click here to add this to my saved trials
Fort Collins, Colorado 80528
?
mi
from
Fort Collins, CO
Click here to add this to my saved trials
Franklin, Wisconsin 53132
?
mi
from
Franklin, WI
Click here to add this to my saved trials
Freehold, New Jersey 07728
?
mi
from
Freehold, NJ
Click here to add this to my saved trials
2720 North Harbor Boulevard
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Grand Blanc, Michigan 48439
?
mi
from
Grand Blanc, MI
Click here to add this to my saved trials
1850 West Arlington Boulevard
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
?
mi
from
Hemet, CA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
11307 Farm to Market 1960 Road West
Houston, Texas 77065
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntington Beach, California 92648
?
mi
from
Huntington Beach, CA
Click here to add this to my saved trials
Huntsville, Alabama 35801
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
?
mi
from
Idaho Falls, ID
Click here to add this to my saved trials
Jackson, Tennessee 38305
?
mi
from
Jackson, TN
Click here to add this to my saved trials
?
mi
from
Kalispell, MT
Click here to add this to my saved trials
4707 Papermill Drive Northwest
Knoxville, Tennessee 37909
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
8860 Center Drive
La Mesa, California 91942
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
?
mi
from
La Mesa, CA
Click here to add this to my saved trials
La Palma, California 90623
?
mi
from
La Palma, CA
Click here to add this to my saved trials
Lake Success, New York 11554
?
mi
from
Lake Success, NY
Click here to add this to my saved trials
?
mi
from
Lakewood, CO
Click here to add this to my saved trials
4202 Collins Road
Lansing, Michigan 48910
?
mi
from
Lansing, MI
Click here to add this to my saved trials
4333 West Saint Joseph Highway
Lansing, Michigan 48917
?
mi
from
Lansing, MI
Click here to add this to my saved trials
Las Cruces, New Mexico 88011
?
mi
from
Las Cruces, NM
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
1003 Olde Waterford Way
Leland, North Carolina 28451
?
mi
from
Leland, NC
Click here to add this to my saved trials
10001 Baptist Health Drive
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Lubbock, TX
Click here to add this to my saved trials
607 South John Redditt Drive
Lufkin, Texas 75904
?
mi
from
Lufkin, TX
Click here to add this to my saved trials
Mansfield, Massachusetts 02048
?
mi
from
Mansfield, MA
Click here to add this to my saved trials
Mather, California 95655
?
mi
from
Mather, CA
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Meridian, ID
Click here to add this to my saved trials
1600 Republic Parkway
Mesquite, Texas 75150
?
mi
from
Mesquite, TX
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Lakes, Florida 33016
?
mi
from
Miami Lakes, FL
Click here to add this to my saved trials
400 East Burdick Expressway
Minot, North Dakota 58701
?
mi
from
Minot, ND
Click here to add this to my saved trials
?
mi
from
Naples, FL
Click here to add this to my saved trials
New Orleans, Louisiana 70121
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10016
?
mi
from
New York, NY
Click here to add this to my saved trials
1211 North Shartel Avenue
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
10170 Nicholas Street
Omaha, Nebraska 68114
?
mi
from
Omaha, NE
Click here to add this to my saved trials
Ormond Beach, Florida 32174
?
mi
from
Ormond Beach, FL
Click here to add this to my saved trials
225 Medical Center Drive
Paducah, Kentucky 42003
?
mi
from
Paducah, KY
Click here to add this to my saved trials
32615 US Highway 19 North
Palm Harbor, Florida 34684
?
mi
from
Palm Harbor, FL
Click here to add this to my saved trials
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
?
mi
from
Peoria, AZ
Click here to add this to my saved trials
26963 Eckel Road
Perrysburg, Ohio 43551
?
mi
from
Perrysburg, OH
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Plano, TX
Click here to add this to my saved trials
Potsdam, New York 13676
?
mi
from
Potsdam, NY
Click here to add this to my saved trials
Raleigh, North Carolina 27617
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
5875 East Riverside Boulevard
Rockford, Illinois 61114
?
mi
from
Rockford, IL
Click here to add this to my saved trials
29200 Harper Avenue
Saint Clair Shores, Michigan 48081
?
mi
from
Saint Clair Shores, MI
Click here to add this to my saved trials
6400 Clayton Road
Saint Louis, Missouri 63117
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33705
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Leandro, California 94578
?
mi
from
San Leandro, CA
Click here to add this to my saved trials
?
mi
from
San Marcos, TX
Click here to add this to my saved trials
404 Brunn School Road
Santa Fe, New Mexico 87505
?
mi
from
Santa Fe, NM
Click here to add this to my saved trials
Seattle, Washington 98104
?
mi
from
Seattle, WA
Click here to add this to my saved trials
?
mi
from
Skokie, IL
Click here to add this to my saved trials
South Charleston, West Virginia 25309
?
mi
from
South Charleston, WV
Click here to add this to my saved trials
105 West 8th Avenue
Spokane, Washington 99204
?
mi
from
Spokane, WA
Click here to add this to my saved trials
4350 South National Avenue
Springfield, Missouri 65807
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Stamford, Connecticut 06905
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Summerville, SC
Click here to add this to my saved trials