A Study to Compare Upadacitinib (ABT-494) Monotherapy to Methotrexate Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who have not Previously taken Methotrexate (SELECT-EARLY)

A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) Once Daily Monotherapy to Methotrexate (MTX) Monotherapy in MTX-Naïve Subjects with Moderately to Severely Active Rheumatoid Arthritis

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003334-27-SK

Enrollment

975

Registered

2015-11-04

Start date

2015-12-11

Completion date

Unknown

Last updated

2020-07-27

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: 21.0 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 = 6 weeks. • Naïve to MTX or, if already on MTX, have received no more than 3 weekly MTX doses with requirement to complete a 4-week MTX washout before the first dose of study drug. • Subjects with prior exposure to conventional synthetic disease modifying anti-rheumatic drugs (csDMARDs) other than MTX may be enrolled if completed the washout period. • Subject meets the following 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. • = 1 bone erosion on x-ray (by local reading) OR in the absence of a documented bone erosion, both positive rheumatoid factor and positive anti-cyclic citrullinated peptide autoantibodies are required 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 731 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 244

Exclusion criteria

Exclusion criteria: • Intolerant to MTX. • Prior exposure to any JAK inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). • Prior exposure to any bDMARD(s). • 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: • To compare the safety and efficacy of Upadacitinib monotherapy versus methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis (RA) in MTX-naïve subjects with moderately to severely active RA. • To compare the efficacy of Upadacitinib monotherapy versus MTX monotherapy for prevention of structural progression in MTX-naive subjects with moderately to severely active RA. • To evaluate the long-term safety, tolerability, and efficacy of Upadacitinib in subjects with RA.;Secondary Objective: Not applicable;Primary end point(s): ACR50 response / the proportion of subjects achieving Clinical Remission (CR) at Week 24.;Timepoint(s) of evaluation of this end point: week 24	—

Measure

Time frame

Main Objective: • To compare the safety and efficacy of Upadacitinib monotherapy versus methotrexate (MTX) monotherapy for the treatment of signs and symptoms of rheumatoid arthritis (RA) in MTX-naïve subjects with moderately to severely active RA. • To compare the efficacy of Upadacitinib monotherapy versus MTX monotherapy for prevention of structural progression in MTX-naive subjects with moderately to severely active RA. • To evaluate the long-term safety, tolerability, and efficacy of Upadacitinib in subjects with RA.;Secondary Objective: Not applicable;Primary end point(s): ACR50 response / the proportion of subjects achieving Clinical Remission (CR) at Week 24.;Timepoint(s) of evaluation of this end point: week 24

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Secondary

Measure	Time frame
Secondary end point(s): • Change from baseline in DAS28 (CRP) • Change from baseline in HAQ-DI • ACR20 response rate • ACR50 response rate • Change from baseline in modified Total Sharp Score (mTSS) • ACR70 response rate • Proportion of subjects achieving LDA based on DAS28 (CRP) = 3.2 • Change from baseline in SF-36 PCS • Proportion of subjects with no radiographic progression (defined as change from baseline in mTSS = 0) at Weeks 24 and 48.;Timepoint(s) of evaluation of this end point: Week 24	—

Measure

Time frame

Secondary end point(s): • Change from baseline in DAS28 (CRP) • Change from baseline in HAQ-DI • ACR20 response rate • ACR50 response rate • Change from baseline in modified Total Sharp Score (mTSS) • ACR70 response rate • Proportion of subjects achieving LDA based on DAS28 (CRP) = 3.2 • Change from baseline in SF-36 PCS • Proportion of subjects with no radiographic progression (defined as change from baseline in mTSS = 0) at Weeks 24 and 48.;Timepoint(s) of evaluation of this end point: Week 24

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Countries

Argentina, Australia, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Egypt, European Union, Finland, Greece, Hong Kong, Hungary, Ireland, Israel, Japan, Kazakhstan, Korea, Republic of, Latvia, Lithuania, Malaysia, Mexico, New Zealand, Poland, Portugal, Puerto Rico, Russian Federation, Serbia, Slovakia, Slovenia, 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