A Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Rheumatoid Arthritis who are on a Stable Dose of Methotrexate and Who Have an Inadequate Response to Methotrexate (SELECT-COMPARE)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo and to Adalimumab in Subjects with Moderately to Severely Active Rheumatoid Arthritis Who are on a Stable Background of Methotrexate (MTX) and Who Have an Inadequate Response to MTX (MTX-IR)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003333-95-BG

Enrollment

1500

Registered

2016-03-25

Start date

2016-07-13

Completion date

Unknown

Last updated

2025-02-17

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 Current Sponsor code: ABT-494 Concentration unit: mg milligram(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Adult male or female, at least 18 years old. • Diagnosis of RA for = 3 months. • Subjects must have been on oral or parenteral MTX therapy = 3 months prior to the first dose of study drug. • Subjects meeting both: = 6 swollen joints and = 6 tender joints at screening and baseline, and hsCRP = 5 mg/L at screening • At least one of the following at Screening: = 3 bone erosions on x-ray OR = 1 bone erosion and a positive rheumatoid factor OR = 1 bone erosion and a positive anti-cyclic citrullinated peptide autoantibodies. • Subjects with prior exposure to at most one bDMARD (except ADA) may be enrolled (up to 20% of total study population) • Except for MTX, subject must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). 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 1125 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 375

Exclusion criteria

Exclusion criteria: • Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). • Subjects who are considered inadequate responders to bDMARD therapy • History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

Design outcomes

Primary

Measure	Time frame
Main Objective: Period 1 • To compare the efficacy of upadacitinib QD versus placebo, and versus adalimumab (ADA) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in subjects with moderately to severely active RA who are on a on a stable background of methotrexate (MTX) and who have an inadequate response to MTX (MTX-IR). • To compare the efficacy of upadacitinib QD versus placebo for the prevention of structural progression in RA subjects with moderately to severely active RA who are on a on a stable background of MTX and who have an inadequate response to MTX (MTX-IR). • To compare the safety and tolerability of upadacitinib QD versus placebo, and versus ADA in subjects with moderately to severely active RA subjects who are on a stable background of MTX and who have an inadequate response to MTX (MTX-IR). Period 2 • To evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of subjects achieving ACR20 response at Week 12 / the proportion of subjects achieving clinical remission (CR) based on DAS28 (CRP) at Week 12 ;Timepoint(s) of evaluation of this end point: week 12	—

Measure

Time frame

Main Objective: Period 1 • To compare the efficacy of upadacitinib QD versus placebo, and versus adalimumab (ADA) for the treatment of signs and symptoms of rheumatoid arthritis (RA) in subjects with moderately to severely active RA who are on a on a stable background of methotrexate (MTX) and who have an inadequate response to MTX (MTX-IR). • To compare the efficacy of upadacitinib QD versus placebo for the prevention of structural progression in RA subjects with moderately to severely active RA who are on a on a stable background of MTX and who have an inadequate response to MTX (MTX-IR). • To compare the safety and tolerability of upadacitinib QD versus placebo, and versus ADA in subjects with moderately to severely active RA subjects who are on a stable background of MTX and who have an inadequate response to MTX (MTX-IR). Period 2 • To evaluate the long-term safety, tolerability, and efficacy of upadacitinib in subjects with RA who have completed Period 1.;Secondary Objective: Not applicable;Primary end point(s): The primary endpoint is the proportion of subjects achieving ACR20 response at Week 12 / the proportion of subjects achieving clinical remission (CR) based on DAS28 (CRP) 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): Ranked: 1. Change from baseline in modified Total Sharp Score (mTSS) at Week 26 2. Proportion of subjects achieving LDA based on Disease Activity Score (DAS)28 [CRP] = 3.2 at Week 12 3. Change from baseline in DAS28 (CRP) at Week 12 4. Change from baseline in Health Assessment Questionnaire (HAQ-DI) at Week 12 5. ACR20 response at Week 12 6. Proportion of subjects achieving LDA based on DAS28 (CRP) = 3.2 at Week 12 (noninferiority of upadacitinib vs. ADA) 7. Change from baseline in Short Form 36 (SF-36) PCS at Week 12 8. Proportion of subjects achieving LDA based on Clinical Disease Activity Index (CDAI) at Week 12 9. Change from baseline in morning stiffness at Week 12 10. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12 11. Proportion of subjects with no radiographic progression at Week 26 Other: 1. ACR50 response at Week 12 2. ACR70 response at Week 12;Timepoint(s) of evaluation of this end point: Week 12 and Week 26	—

Measure

Time frame

Secondary end point(s): Ranked: 1. Change from baseline in modified Total Sharp Score (mTSS) at Week 26 2. Proportion of subjects achieving LDA based on Disease Activity Score (DAS)28 [CRP] = 3.2 at Week 12 3. Change from baseline in DAS28 (CRP) at Week 12 4. Change from baseline in Health Assessment Questionnaire (HAQ-DI) at Week 12 5. ACR20 response at Week 12 6. Proportion of subjects achieving LDA based on DAS28 (CRP) = 3.2 at Week 12 (noninferiority of upadacitinib vs. ADA) 7. Change from baseline in Short Form 36 (SF-36) PCS at Week 12 8. Proportion of subjects achieving LDA based on Clinical Disease Activity Index (CDAI) at Week 12 9. Change from baseline in morning stiffness at Week 12 10. Change from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 12 11. Proportion of subjects with no radiographic progression at Week 26 Other: 1. ACR50 response at Week 12 2. ACR70 response at Week 12;Timepoint(s) of evaluation of this end point: Week 12 and Week 26

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Countries

Argentina, Australia, Austria, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Croatia, Czech Republic, Denmark, European Union, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russian Federation, Serbia, Slovakia, South Africa, Spain, 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