A Study Investigating the Efficacy and Safety of ABT-494 Given With Methotrexate in Subjects With Rheumatoid Arthritis Who Failed Anti-Tumor Necrosis Factor (TNF) Biologic Therapy

This is a multi center, randomized, double-blind, placebo-controlled phase 2 study in subjects with moderately to severely active rheumatoid arthritis on background methotrexate who have failed anti-Tumor Necrosis Factor (TNF) biologic therapy.

April 18, 2014
Rheumatology - Rheumatoid Arthritis
Philip J. Mease, MD

Inclusion Criteria:

  • Diagnosed with RA based on either the 1987-revised American College of Rheumatology (ACR) classification criteria or the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria for ≥ 3 months.
  • Subjects must have been receiving oral or parenteral MTX therapy ≥ 3 months and on a stable prescription of 7.5 to 25 mg/week for at least 4 weeks prior to initiating the study drug. Subjects should also be on a stable dose of folic acid (or equivalent) for at least 4 weeks prior to initiating the study drug. Subjects should continue with their stable doses of MTX and folic acid throughout the study
  • Subjects have been treated with 1 or 2 anti-TNF biologics for ≥ 3 months but continue to exhibit active RA, or had to discontinue due to intolerability or toxicity. In addition, subjects may have received up to 1 non-anti-TNF biologic (e.g., abatacept, rituximab, anakinra, or tocilizumab) prior to Screening.
  • Have active RA as defined by the following minimum disease activity criteria:

>= 6 swollen joints (based on 66 joint counts) at Screening and Baseline, >= 6 tender joints (based on 68 joint counts) at Screening and Baseline, hs-CRP > Upper Limit of Normal (ULN) OR positive for both rheumatoid factor and anti-CCP antibody.

Exclusion Criteria:

  • Prior exposure to Janus Activated Kinase (JAK) inhibitor (e.g. tofacitinib, baricitinib)
  • Pregnant or breastfeeding female
  • Ongoing or active infection.
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