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



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - 100
Updated:7/2/2016
Start Date:October 2013
End Date:July 2015

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A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Safety and Efficacy of ABT-494 Given With Methotrexate (MTX) in Subjects With Moderately to Severely Active Rheumatoid Arthritis (RA) Who Have Had an Inadequate Response or Intolerance to Anti-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.


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 more anti-TNF biologics (no maximum cap) for ≥ 3
months but continue to exhibit active RA, or had to discontinue due to intolerability
or toxicity. In addition, subjects with prior exposure to non-anti-TNF biologic(s)
(no maximum cap) (e.g., abatacept, rituximab, anakinra, or tocilizumab) are allowed.

- 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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