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)

A Phase 3, Randomized, Active-Controlled, Double Blind Study Comparing Upadacitinib 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)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000933-37-HU

Enrollment

550

Registered

2016-10-12

Start date

2016-11-24

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Rheumatoid Arthritis (RA) MedDRA version: 23.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Interventions

Product Name: Upadacitinib Product Code: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: Upadacitinib CAS Number: 1310726-60-3 Other descriptive name: ABT-494 Concentration unit: mg milligram

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult male or female, at least 18 years old. 2. Diagnosis of RA for = 3 months. 3. Subjects 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. 4. Subjects 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: MTX, sulfasalazine, hydroxychloroquine, chloroquine, and leflunomide. A combination of up to two background csDMARDs is allowed except the combination of MTX and leflunomide. 5. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 413 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 137

Exclusion criteria

Exclusion criteria: 1. Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). 2. Prior exposure to abatacept 3. History of inflammatory joint disease other than RA. Current diagnosis of secondary Sjogren's Syndrome is permitted.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-intolerant subjects with moderately to severely active RA. 2. To evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in subjects with RA.;Secondary Objective: 1. Change from baseline in DAS28 (CRP) at Week 12 (superiority); 2. Proportion of subjects achieving Clinical Remission (CR) at Week 12 (superiority) ;Primary end point(s): Change from baseline in DAS28 (CRP) (non-inferiority).;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Main Objective: 1. To compare the safety and efficacy of upadacitinib 15 mg once daily (QD) versus abatacept intravenous (IV) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in bDMARD-inadequate response (bDMARD-IR) or bDMARD-intolerant subjects with moderately to severely active RA. 2. To evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD in subjects with RA.;Secondary Objective: 1. Change from baseline in DAS28 (CRP) at Week 12 (superiority); 2. Proportion of subjects achieving Clinical Remission (CR) at Week 12 (superiority) ;Primary end point(s): Change from baseline in DAS28 (CRP) (non-inferiority).;Timepoint(s) of evaluation of this end point: Week 12

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline in DAS28 (CRP) (superiority); 2. Proportion of subjects achieving Clinical Remission (CR) (superiority) ;Timepoint(s) of evaluation of this end point: Week 12	—

Countries

Argentina, Australia, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Czechia, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Korea, Democratic People's Republic of, Latvia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Turkey, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

global-clinical-trials@abbvie.com441628561090

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026