Last updated on January 2018

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


Brief description of study

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

Detailed Study Description

Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease of unknown etiology. The hallmark feature of RA is an inflammatory process manifested by persistent symmetric polyarthritis of synovial joints which can ultimately lead to bone erosions, deformity, and disability. Evidence suggests that inhibition of Janus kinase (JAK)-mediated pathways is a promising approach for the treatment of patients with rheumatoid arthritis. ABT-494 is a novel selective JAK1 inhibitor being developed for the treatment of adult patients with moderately to severely active RA. This is a Phase 3 multicenter study that includes two periods. In Period 1 this study will compare the safety and efficacy (signs and symptoms) of ABT-494 30 mg once daily (QD) alone and 15 mg QD alone versus continuing methotrexate (MTX) alone in MTX-inadequate response (MTX-IR) subjects with moderately to severely active rheumatoid arthritis (RA). Period 2 is a blinded long-term extension period to evaluate the long-term safety, tolerability, and efficacy of ABT-494 30 mg QD and 15 mg QD in subjects with RA who have completed Period 1.

Clinical Study Identifier: TX144026

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Gail Lewis

University of South Florida-Morsani College of Medicine
Tampa, FL USA
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