A Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Rheumatoid Arthritis on a Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response to csDMARDs Alone



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 99
Updated:3/8/2019
Start Date:December 17, 2015
End Date:October 1, 2021

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A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo in Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are on a Stable Dose of Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) and Have an Inadequate Response to csDMARDs

This is a multi center, randomized, double-blind, placebo-controlled phase 3 study in
subjects with moderately to severely active rheumatoid arthritis on a stable dose of csDMARDs
who have had an inadequate response to csDMARDs.


Inclusion Criteria:

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

- Diagnosis of Rheumatoid Arthritis (RA) for greater than or equal to 3 months.

- Subjects have been receiving conventional synthetic DMARD (csDMARD) therapy for
greater than or equal to 3 months and on a stable dose for greater than or equal to 4
weeks prior to the first dose of study drug. The following csDMARDs are allowed:
Methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide.

- 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.

- Subjects with prior exposure to at most one biologic DMARD (bDMARD) may be enrolled
(up to 20% of study population) if they have documented evidence of intolerance to
bDMARDs or limited exposure (less than 3 months) and have satisfied required washout
periods.

Exclusion Criteria:

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

- History of inflammatory joint disease other than RA. History of secondary Sjogren's
Syndrome is permitted.

- Subjects who are considered inadequate responders to bDMARD therapy as determined by
the Investigator.
We found this trial at
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Austin, Texas 78739
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Clearwater, Florida 33765
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College Station, Texas 77845
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Covina, California 91722
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200 Spruce Street
Denver, Colorado 80230
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Duncansville, Pennsylvania 16635
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Encino, California 91436
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Franklin, Wisconsin 53132
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Indianapolis, Indiana 46202
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2301 South Clear Creek Road
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La Jolla, California 92037
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4202 Collins Road
Lansing, Michigan 48910
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Lansing, Michigan 48910
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470 Cooper Drive
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Los Angeles, California 90045
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200 Copeland Drive
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5604 Gulf Drive
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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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225 Medical Center Drive
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32615 US Highway 19 North
Palm Harbor, Florida 34684
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51 Sewall Street
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5875 East Riverside Boulevard
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Salisbury, North Carolina 28144
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Springfield, Illinois 62703
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565 Lakeview Parkway
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Waco, Texas 76710
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1907 Tradd Court
Wilmington, North Carolina 28401
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