A Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) Monotherapy in Subjects With Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 99
Updated:3/8/2019
Start Date:March 2, 2016
End Date:February 27, 2022

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A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Monotherapy to Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response to MTX

This is a randomized, double-blind study comparing Upadacitinib (ABT-494) monotherapy to
Methotrexate (MTX) monotherapy in subjects with moderately to severely active rheumatoid
arthritis who have had an inadequate response to methotrexate treatment.


Inclusion Criteria:

- Diagnosis of RA for >= 3 months.

- Subjects must have been on oral or parenteral MTX therapy >= 3 months and on a stable
dose for >= 4 weeks prior to first dose of study drug.

- Must have discontinued all conventional synthetic disease-modifying anti-rheumatic
drugs (csDMARDs) (other than MTX) >= 4 weeks prior to first dose of study drug.

- Meets the following minimum disease activity criteria: >= 6 swollen joints (based on
66 joint counts) and >= 6 tender joints (based on 68 joint counts) at Screening and
Baseline Visits.

Exclusion Criteria:

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

- Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs).

- Current diagnosis of inflammatory joint disease other than RA. Current diagnosis of
secondary Sjogren's Syndrome is permitted.
We found this trial at
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Jonesboro, Arkansas 72401
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711 Encino Place Northeast
Albuquerque, New Mexico 87102
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4534 West Gate Boulevard
Austin, Texas 78745
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Carrollton, Texas 75007
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Chesapeake, Virginia 23320
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Chicago, Illinois 60640
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College Station, Texas 77845
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Colorado Springs, Colorado 80920
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Corpus Christi, Texas 78404
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1 Elizabeth Place
Dayton, Ohio 45417
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2712 North Decatur Road
Decatur, Georgia 30033
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Fort Lauderdale, Florida 33309
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Franklin, Wisconsin 53132
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Franklin, WI
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Gilbert, AZ
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7021 Augusta Road
Greenville, South Carolina 29601
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Hemet, CA
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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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10700 Stancliff Road
Houston, Texas 77099
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Huntsville, Alabama 35801
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Las Cruces, New Mexico 88011
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Lebanon, New Hampshire 03756
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607 South John Redditt Drive
Lufkin, Texas 75904
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200 Copeland Drive
Mansfield, Massachusetts 02048
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1600 Republic Parkway
Mesquite, Texas 75150
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Miami Springs, Florida 33166
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6001 Airport Boulevard
Mobile, Alabama 36608
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3402 Magnolia Cove
Monroe, Louisiana 71203
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Nashville, TN
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1020 Medical Park Avenue
New Bern, North Carolina 28562
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New Orleans, Louisiana 70121
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1211 North Shartel Avenue
Oklahoma City, Oklahoma 73103
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10040 Regency Circle
Omaha, Nebraska 68114
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4520 East Indian School Road
Phoenix, Arizona 85018
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Pinellas Park, Florida 33781
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303 East Quincy Street
San Antonio, Texas 78215
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Sarasota, Florida 34239
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Shreveport, Louisiana 71101
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4202 East Fowler Avenue
Tampa, Florida 33612
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4612 North Habana Avenue
Tampa, Florida 33614
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The Woodlands, Texas 77382
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13406 Medical Complex Drive
Tomball, Texas 77375
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611 Highway 6
Waco, Texas 76710
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Wichita, KS
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