Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

To Learn more

CW ID: 216049
Date Last Changed: June 14, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Abbvie
Facility Type
N/A

Eligibility

Inclusion Criteria:
  • Diagnosis of RA for ≥ 3 months who also fulfill either the 1987-revised ACR classification criteria or the 2010 ACR/ EULAR classification criteria for RA.
  • Subjects must have been on oral or parenteral MTX therapy ≥ 3 months and on a stable dose (15 to 25 mg/week; or ≥ 10 mg/week in subjects who are intolerant of MTX at doses ≥ 15 mg/week after complete titration) for ≥ 4 weeks prior to Screening.
  • Must have discontinued all conventional synthetic disease-modifying anti-rheumatic drugs(csDMARDs) (other than MTX; see Inclusion Criterion 2) ≥ 4 weeks prior to first dose of study
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 drug.

Contact

Gail Lewis
University of South Florida - Morsani Center for Advanced Healthcare
13330 USF Laurel Drive
Tampa, FL 33612
Phone: 813-974-9509

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