A Phase 3 Study to Compare Upadacitinib to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease- Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs ( SELECT-CHOICE )



Status:Active, not recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:May 9, 2017
End Date:June 7, 2022

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A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib (ABT-494) to Abatacept in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs) on Stable Conventional Synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARDs)

The comparison of safety and efficacy of upadacitinib versus abatacept in participants with
rheumatoid arthritis on a stable background conventional synthetic Disease Modifying
Anti-Rheumatic Drug (csDMARD) who have an inadequate response or intolerance to biologic
DMARDs.


Inclusion Criteria:

- Diagnosis of rheumatoid arthritis (RA) for >= 3 months.

- Participants have been treated for >= 3 months with >= 1 bDMARD therapy, but continue
to exhibit active RA or had to discontinue due to intolerability or toxicity,
irrespective of treatment duration and have never received abatacept prior to the
first dose of study drug.

- Participants have been receiving csDMARD therapy >= 3 months and on a stable dose for
>= 4 weeks prior to the first dose of study drug. The following csDMARDs are allowed:
methotrexate (MTX), sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A
combination of up to two background csDMARDs is allowed except the combination of MTX
and leflunomide.

- Meets the following criteria: >= 6 swollen joints (based on 66 joint counts) and >= 6
tender joints (based on 68 joint counts) at Screening and Baseline Visits and hsCRP >=
3 mg/L at Screening .

Exclusion Criteria:

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

- Prior exposure to abatacept

- History of any arthritis with onset prior to age 17 years or current diagnosis of
inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's
Syndrome is permitted

- Laboratory values meeting the following criteria within the Screening period prior to
the first dose of study drug: serum aspartate transaminase > 2 × upper limit of normal
(ULN); serum alanine transaminase > 2 × ULN; estimated glomerular filtration rate by
simplified 4-variable Modification of Diet in Renal Disease formula < 40 milli liter
(mL)/minute/1.73 meter (m)^2; total white blood cell count < 2,500/micro liter (μL);
absolute neutrophil count < 1,500/μL; platelet count < 100,000/μL; absolute lymphocyte
count < 800/μL; and hemoglobin < 10 g/ deciliter (dL).
We found this trial at
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New Orleans, Louisiana 70121
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Bethlehem, Pennsylvania 18015
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Capital Federal, Buenos Aires
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Champaign, Illinois 61820
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Clearwater, Florida 33765
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Corpus Christi, Texas 78404
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Decatur, GA
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200 Spruce Street
Denver, Colorado 80230
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Duncansville, Pennsylvania 16635
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Fort Collins, Colorado 80528
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Fullerton, California 92835
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Grand Rapids, Michigan 49546
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1850 West Arlington Boulevard
Greenville, North Carolina 27834
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Hot Springs, Arkansas 71913
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Jackson, Tennessee 38305
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8860 Center Drive
La Mesa, California 91942
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Lake Success, New York 11554
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Lakewood, Colorado 80228
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4202 Collins Road
Lansing, Michigan 48910
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Las Cruces, New Mexico 88011
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470 Cooper Drive
Lexington, Kentucky 40504
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607 South John Redditt Drive
Lufkin, Texas 75904
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Meridian, ID
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New York, New York 10016
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225 Medical Center Drive
Paducah, Kentucky 42003
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Pittsburgh, Pennsylvania 15260
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Portland, OR
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410 Mocksville Avenue
Salisbury, North Carolina 28144
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Salt Lake City, Utah 84124
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4350 South National Avenue
Springfield, Missouri 65807
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Summit, New Jersey 07901
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Tamarac, FL
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13406 Medical Complex Drive
Tomball, Texas 77375
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Toms River, New Jersey 08755
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Toms River, New Jersey 08755
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Tucson, Arizona 85704
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411 Commercial Court
Venice, Florida 34292
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Wheaton, MD
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1907 Tradd Court
Wilmington, North Carolina 28401
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Winston-Salem, North Carolina 27157
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