A Study Comparing ABT-494 to Placebo and to Adalimumab in Subjects With Rheumatoid Arthritis Who Are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:December 1, 2015
End Date:May 20, 2022

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A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

This is a phase 3, randomized, double-blind study comparing ABT-494 to Placebo and to
Adalimumab in subjects with moderately to severely active rheumatoid arthritis who are on a
stable background of Methotrexate (MTX) and who have an inadequate response to MTX.


Inclusion Criteria:

- Adult male or female, at least 18 years old.

- Diagnosis of RA for greater than or equal to 3 months.

- Subjects must have been on oral or parenteral methotrexate (MTX) therapy greater than
or equal to 3 months and on a stable prescription of greater than or equal to 15 to 25
mg/week (or greater than or equal to 10 mg/week in subjects intolerant of MTX at doses
greater than or equal to 12.5 mg/week) for greater than or equal to 4 weeks prior to
the first dose of study drug. In addition all subjects should take a dietary
supplement of folic acid or folinic acid throughout the study participation.

- Meets the following minimum disease activity criteria: greater than or equal to 6
swollen joints (based on 66 joint counts) and greater than or equal to 6 tender joints
(based on 68 joint counts) at Screening and Baseline Visits.

- At least one of the following at Screening: greater than or equal to 3 bone erosions
on x-ray OR greater than or equal to 1 bone erosion and a positive rheumatoid factor
OR greater than or equal to 1 bone erosion and a positive anti-cyclic citrullinated
peptide autoantibodies.

- Subjects with prior exposure to only one Biological disease-modifying anti-rheumatic
drugs (bDMARD) (except ADA) may be enrolled (up to 20% of total study population) if
they have documented evidence of intolerance to the bDMARD or limited exposure (less
than 3 months), but required washout periods need to be satisfied.

- Except for MTX, subject must have discontinued all conventional synthetic
disease-modifying anti-rheumatic drugs (csDMARDs).

Exclusion Criteria:

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

- Subjects who have been exposed to adalimumab or who are considered inadequate
responders to bDMARD therapy as determined by the Investigator.

- History of inflammatory joint disease other than RA. History of secondary Sjogren's
Syndrome is permitted.
We found this trial at
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711 Encino Place Northeast
Albuquerque, New Mexico 87102
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Arlington, Virginia 22205
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6835 Austin Center Boulevard
Austin, Texas 78731
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Aventura, Florida 33180
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8641 Wilshire Boulevard
Beverly Hills, California 90211
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2017 Canyon Road
Birmingham, Alabama 35216
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Boynton Beach, Florida 33472
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Capital Federal, Buenos Aires
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Charlotte, North Carolina 28204
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10370 Park Road
Charlotte, North Carolina 28210
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Chesapeake, Virginia 23320
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Chicago, Illinois 60640
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Clearwater, Florida 33765
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Colorado Springs, Colorado 80920
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1711 Saint Julian Place
Columbia, South Carolina 29204
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1900 Mason Avenue
Daytona Beach, Florida 32117
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915 East 1st Street
Duluth, Minnesota 55805
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Duncansville, Pennsylvania 16635
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Durham, North Carolina 27704
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5501 South McColl Road
Edinburg, Texas 78539
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El Paso, Texas 79935
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Encino, California 91436
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215 South Hickory Street
Escondido, California 92025
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Fort Collins, Colorado 80528
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Franklin, Wisconsin 53132
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71 Thomas Johnson Drive
Frederick, Maryland 21702
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Gainesville, Georgia 30501
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7021 Augusta Road
Greenville, South Carolina 29601
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2060 Space Park Drive
Houston, Texas 77004
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2060 Space Park Drive
Houston, Texas 77034
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11307 Farm to Market 1960 Road West
Houston, Texas 77065
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10700 Stancliff Road
Houston, Texas 77099
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2301 South Clear Creek Road
Killeen, Texas 76549
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Kingsport, Tennessee 37660
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4707 Papermill Drive Northwest
Knoxville, Tennessee 37909
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La Jolla, California 92037
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8860 Center Drive
La Mesa, California 91942
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4202 Collins Road
Lansing, Michigan 48910
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Las Cruces, New Mexico 88011
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Lawrenceville, Georgia 30045
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1003 Olde Waterford Way
Leland, North Carolina 28451
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Los Alamitos, California 90720
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Los Angeles, California 11373
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607 South John Redditt Drive
Lufkin, Texas 75904
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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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Missouri City, Texas 77459
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1020 Medical Park Avenue
New Bern, North Carolina 28562
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10040 Regency Circle
Omaha, Nebraska 68114
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Orlando, Florida 32806
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72855 Fred Waring Drive
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32615 US Highway 19 North
Palm Harbor, Florida 34684
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32615 US Highway 19 North
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Raleigh, North Carolina 27617
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151 North Sunrise Avenue
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29200 Harper Avenue
Saint Clair Shores, Michigan 48081
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Saint Petersburg, Florida 33705
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303 East Quincy Street
San Antonio, Texas 78215
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105 West 8th Avenue
Spokane, Washington 99204
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3922 Woodley Road
Toledo, Ohio 43608
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13406 Medical Complex Drive
Tomball, Texas 77375
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