Key Exclusion Criteria:

Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 10 weeks after the last dose of investigational product
b) Women who are pregnant or breastfeeding, or plan to become pregnant, or to start breastfeeding during the duration of the study
c) Women with a positive pregnancy test on enrollment or prior to
investigational product administration.
2) Medical History and Concurrent Diseases
a) Subjects who are scheduled for or anticipate joint replacement surgery.
b) Subjects who have a recent history of clinically significant drug or alcohol abuse
c) Concomitant illness that in the opinion of the Investigator, is likely to require systemic glucocorticosteroid therapy during the study (e.g.; moderate to severe asthma)
d) Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, pulmonary, cardiac, neurological, ophthalmologic or cerebral disease. Concomitant medical conditions that in the opinion of the Investigator might place the subject at unacceptable risk for participation in this study
e) Subjects who are unwilling or unable to have screening performed based on current local or country guidelines/standards to evaluate the presence of cancer (e.g. breast, cervical, colon, prostate, hepatocellular, gastric).
f) Subjects with a history or current evidence of malignancies; specifically, subjects with:
? a history of cancer within the last five years (other than non-melanoma skin cell cancers cured by local resection), or
? evidence of current malignancy or signs of possible malignancy
detected by screening procedures for which the workup to exclude
malignancy has not been completed or malignancy cannot be
excluded.
? Female subjects who have had a manual examination or breast cancer
imaging (mammogram, ultrasound, other method) screening study that
is suspicious for malignancy, and in whom the possibility of
malignancy cannot be reasonably excluded following additional
clinical, laboratory, or other diagnostic evaluations
? NOTE: The following subjects may be enrolled; those with:
− Non-melanoma skin cell cancers, present at or before screening,
which have been entirely removed prior to enrollment, or
− Carcinoma in situ, present at or before screening, that will have
been treated with definitive surgical intervention prior to
enrollment.
− No evidence of malignancy upon completion of evaluation
prompted by suspicious screening procedure.
g) Subjects at risk for tuberculosis (TB). Specifically, subjects with:
? Current clinical, radiographic or laboratory evidence of active or latent TB
? A history of active TB within the last 3 years even if it was treated.
? A history of active TB greater than 3 years ago if there is no
documentation that the prior anti-TB treatment was appropriate in
duration and type.
h) Subjects with any serious bacterial infection within the last 3 months, not treated and resolved with antibiotics, or any chronic bacterial infection (such as, but not limited to, chronic pyelonephritis, osteomyelitis and bronchiectasis)
i) Subjects with evidence (as assessed by the Investigator) of active or latent bacterial or viral infections at the time of potential enrollment, including subjects with evidence of Human Immunodeficiency Virus (HIV).
j) Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months prior to signing informed consent
k) Subject who have received any live vaccines within 3 months of the
anticipated first dose of study medication or who will have need of a live vaccine at any time, during and for 3 months after the duration of the study
3) Physical and Laboratory Test Findings
a) Subjects with Hepatitis B surface antigen.
b) Subjects with Hepatitis C antibody-positive subjects who are also RIBApositive or PCR positive.
c) Subjects with any of the following laboratory values:
i. Hgb < 8.5 g/dL.
ii. WBC < 3,000/mm3 (3 x 109/L)
iii. Platelets < 100,000/mm3 (100 x 109/L).
iv. Serum creatinine > 2 times upper limit of normal.
v. Serum ALT or AST > 2 times upper limit of normal.
vi. Any other laboratory test results that, in the opinion of the investigator,might place the subject at unacceptable risk for participation in this study.