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

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

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
45
sites
Champaign, Illinois 61820
?
mi
from
Champaign, IL
Click here to add this to my saved trials
?
mi
from
Albany, NY
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Capital Federal, Buenos Aires
?
mi
from
Capital Federal,
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
Corpus Christi, Texas 78404
?
mi
from
Corpus Christi, TX
Click here to add this to my saved trials
?
mi
from
Decatur, GA
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
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
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
Fullerton, California 92835
?
mi
from
Fullerton, CA
Click here to add this to my saved trials
Grand Rapids, Michigan 49546
?
mi
from
Grand Rapids, 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
Hot Springs, Arkansas 71913
?
mi
from
Hot Springs, AR
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
8860 Center Drive
La Mesa, California 91942
?
mi
from
La Mesa, 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
Lakewood, Colorado 80228
?
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
Las Cruces, New Mexico 88011
?
mi
from
Las Cruces, NM
Click here to add this to my saved trials
470 Cooper Drive
Lexington, Kentucky 40504
?
mi
from
Lexington, KY
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
?
mi
from
Meridian, ID
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
?
mi
from
Ocoee, 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
?
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
Pittsburgh, Pennsylvania 15260
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
410 Mocksville Avenue
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
Salt Lake City, Utah 84124
?
mi
from
Salt Lake City, UT
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
Summit, New Jersey 07901
?
mi
from
Summit, NJ
Click here to add this to my saved trials
?
mi
from
Sun City, AZ
Click here to add this to my saved trials
?
mi
from
Tamarac, FL
Click here to add this to my saved trials
13406 Medical Complex Drive
Tomball, Texas 77375
?
mi
from
Tomball, TX
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
Tucson, Arizona 85704
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
411 Commercial Court
Venice, Florida 34292
?
mi
from
Venice, FL
Click here to add this to my saved trials
?
mi
from
Wheaton, MD
Click here to add this to my saved trials
1907 Tradd Court
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials