Methotrexate Withdrawal Study of Tofacitinib Modified Release Formulation in Subjects With Rheumatoid Arthritis

Key Inclusion Criteria

- 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 has taken a stable weekly dose of oral MTX
with supplemental folic acid or folinic acid for at least 4 weeks prior to the
baseline visit (conversion from parenteral MTX to oral MTX will require stabilization
of the treatment regimen for at least 1 month).

- Subjects must screen negative for active tuberculosis or inadequately treated
tuberculosis infection (active or latent).

Key Exclusion Criteria

- 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 any current malignancy or
a history of malignancy (except adequately treated or excised non-metastatic basal
cell or squamous cell cancer of the skin or cervical carcinoma in situ); 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 biologics, regardless of the
class.