A Study Comparing 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 (SELECT-NEXT)

A Phase 3, Randomized, Double-Blind Study Comparing 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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003332-13-SK

Enrollment

600

Registered

2015-11-04

Start date

2016-01-12

Completion date

Unknown

Last updated

2022-04-25

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: ABT-494 Pharmaceutical Form: Tablet INN or Proposed INN: ABT-494 CAS Number: 1310726-60-3 Current Sponsor code: ABT-494 Concentration unit: mg milligram(s) Concentration type: equal Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult male or female, at least 18 years old. • Diagnosis of RA for = 3 months. • 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. • Meets the 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. • Subjects with prior exposure to at most one bDMARD may be enrolled (up to 20% of study population). Specifically, prior to enrollment: a. Subjects with limited exposure to bDMARD (=65 years) yes F.1.3.1 Number of subjects for this age range 150

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: • To compare the efficacy of ABT-494 versus placebo for the treatment of signs and symptoms of subjects with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response to csDMARDs. • To compare the safety and tolerability of ABT-494 versus placebo in subjects with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs. • To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of subjects achieving ACR20 response / the proportion of subjects achieving LDA at Week 12.;Timepoint(s) of evaluation of this end point: week 12	—

Measure

Time frame

Main Objective: • To compare the efficacy of ABT-494 versus placebo for the treatment of signs and symptoms of subjects with moderately to severely active rheumatoid arthritis (RA) who are on a stable dose of conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and have an inadequate response to csDMARDs. • To compare the safety and tolerability of ABT-494 versus placebo in subjects with moderately to severely active RA who are on a stable dose of csDMARDs and have an inadequate response to csDMARDs. • To evaluate the long-term safety, tolerability, and efficacy of ABT-494 in subjects with RA. ;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of subjects achieving ACR20 response / the proportion of subjects achieving LDA at Week 12.;Timepoint(s) of evaluation of this end point: week 12

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Secondary

Measure	Time frame
Secondary end point(s): 1. Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) 2. Change from baseline in HAQ-DI 3. ACR 20 response rate 4. Change from baseline in SF-36 PCS 5. Proportion of subjects achieving Clinical remission (CR) based on DAS28 (CRP) 6. Proportion of subjects achieving LDA based on CDAI = 10; 7. Change from baseline in morning stiffness 8. Change from baseline in FACIT-F;Timepoint(s) of evaluation of this end point: Week 12	—

Measure

Time frame

Secondary end point(s): 1. Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) 2. Change from baseline in HAQ-DI 3. ACR 20 response rate 4. Change from baseline in SF-36 PCS 5. Proportion of subjects achieving Clinical remission (CR) based on DAS28 (CRP) 6. Proportion of subjects achieving LDA based on CDAI = 10; 7. Change from baseline in morning stiffness 8. Change from baseline in FACIT-F;Timepoint(s) of evaluation of this end point: Week 12

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Countries

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, Egypt, European Union, Finland, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

eu-clinical-trials@abbvie.com+441628561090

Outcome results

None listed

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