- Must be 18 years of age or older.
- Have a score of 6 or greater on the 2010 American College of Rheumatology/European League
Against Rheumatism Classification Criteria for Rheumatoid Arthritis at and/or prior to
Screening Visit.
- Have ≥4 tender/painful joints on motion and ≥4 swollen joints (28 joint counts) at
both Screening Visit and Baseline Visit (Visit 1).
- Have moderate to severe disease activity as defined by CDAI>10 and DAS28-4(ESR) ≥3.2
at Baseline Visit.
- Have taken an oral MTX treatment regimen (15-25mg/week) continuously for at least 4
months prior to the screening visit and takes weekly dose of oral MTX
with supplemental folic acid or folinic acid prior to first dose.
- Screen negative for active tuberculosis or inadequately treated
tuberculosis infection (active or latent).
- Pregnant female subjects; breastfeeding female subjects; male subjects with partners
currently pregnant; male subjects able to father children and female subjects of
childbearing potential who are unwilling or unable to use 2 highly effective methods
of contraception as outlined in this protocol for the duration of the study and for
at least 3 months after the last dose of investigational product.
- Subjects with infection or infection history.
- Subjects with history of, or current evidence for, severe gastrointestinal narrowing (pathologic or iatrogenic); and subjects with history of documented diverticulitis.
- Subjects with a history of insufficient response to 2 or more biologics, regardless of the
class.