A Study Comparing ABT-494 Monotherapy to Methotrexate (MTX) Monotherapy in Subjects with Rheumatoid Arthritis (RA) Who Have an Inadequate Response to MTX (SELECT-MONOTHERAPY)

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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003376-75-ES

Enrollment

600

Registered

2016-01-19

Start date

2016-06-23

Completion date

Unknown

Last updated

2016-07-04

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: 19.0 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 must have been on oral or parenteral MTX therapy ? 3 months and on a stable dose for ? 4 weeks prior to Screening. ? Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) (other than MTX) ? 4 weeks prior to first dose of study drug. ? Meets the following 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. 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 465 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 135

Exclusion criteria

Exclusion criteria: ? Prior exposure to any Janus kinase (JAK) inhibitor (including but not limited to tofacitinib, baricitinib, and filgotinib). ? Prior exposure to any biological disease-modifying anti-rheumatic drugs (bDMARDs). ? History of inflammatory joint disease other than RA. History of secondary Sjogren's Syndrome is permitted.

Design outcomes

Primary

Measure	Time frame
Main Objective: ? To compare the safety and efficacy (signs and symptoms) of ABT-494 monotherapy versus MTX in MTX-inadequate response (MTX-IR) subjects with moderately to severely active rheumatoid arthritis (RA). ? 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 two primary endpoints are the proportion of subjects achieving ACR20 and low disease activity (LDA) at Week 14.;Timepoint(s) of evaluation of this end point: Week 14	—

Measure

Time frame

Main Objective: ? To compare the safety and efficacy (signs and symptoms) of ABT-494 monotherapy versus MTX in MTX-inadequate response (MTX-IR) subjects with moderately to severely active rheumatoid arthritis (RA). ? 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 two primary endpoints are the proportion of subjects achieving ACR20 and low disease activity (LDA) at Week 14.;Timepoint(s) of evaluation of this end point: Week 14

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Secondary

Measure	Time frame
Secondary end point(s): ? Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) ? Change from baseline in HAQ-DI (Health Assessment Questionnaire - Disability Index) ? ACR50 response ? ACR70 response ? Change from Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) ? Proportion of subjects achieving CR based on DAS28 (CRP) ? Change from baseline in morning stiffness (severity);Timepoint(s) of evaluation of this end point: Week 14	—

Measure

Time frame

Secondary end point(s): ? Change from baseline in Disease Activity Score (DAS) 28 (C-reactive protein [CRP]) ? Change from baseline in HAQ-DI (Health Assessment Questionnaire - Disability Index) ? ACR50 response ? ACR70 response ? Change from Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) ? Proportion of subjects achieving CR based on DAS28 (CRP) ? Change from baseline in morning stiffness (severity);Timepoint(s) of evaluation of this end point: Week 14

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Countries

Argentina, Australia, Austria, Chile, Colombia, European Union, Israel, Japan, Mexico, New Zealand, Puerto Rico, Russian Federation, Serbia, Spain, Turkey, Ukraine, United States

Contacts

Public ContactEU Clinical Trials Helpdesk

AbbVie Ltd

abbvie_reec@abbvie.com+34901 20 01 03

Outcome results

None listed

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