A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP5094 Following Multiple Intravenous Doses in Subjects With Rheumatoid Arthritis on Methotrexate

Exclusion Criteria

• •Subject has an ongoing clinically significant systemic disease such as uncompensated heart failure, uncontrolled diabetes mellitus, severe hepatic failure, severe pulmonary disease or inflammatory bowel disease.
• •Subject has a history of any malignancy in the past 5 years, except for adequately-treated, nonmelanoma skin cancer and adequately-treated in-situ cervical cancer.
• •Subject has a history of severe allergic or anaphylactic reactions to drugs.
• •Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 6 months prior to screening (Note: 1 unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
• •Subject has an ongoing infection or has had an infection requiring intravenous antibiotics within 1 month prior to day 1.
• •Subject has a known history of a positive test for human immunodeficiency virus (HIV) antibody.
• •Subject has a past history of serious opportunistic infection.
• •Subject has a positive QuantiFERON-TB Gold test within 90 days of, or at screening, and has not completed an adequate course of antimicrobial therapy per Centers for Disease Control or local guidelines.
• •Subject's laboratory test results at screening or prior to study drug dosing on day 1:
• •* Outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests, and/or
• •* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) are \> 2 times the upper limit of normal.
• •Subject received any live or live-attenuated vaccine within 30 days prior to day 1.
• •Subject received any of the following:
• •* Oral or injectable gold, azathioprine, penicillamine, cyclosporine, tacrolimus or tofacitinib (Xeljanz®) within 30 days prior to day 1.
• •* Anakinra (Kineret®), etanercept (Enbrel®), adalimumab (Humira®), tocilizumab (Actemra®), infliximab (Remicade®), or golimumab (Simponi®) within 60 days prior to day 1.
• •* Leflunomide (Arava®) within 60 days prior to day 1, unless the subject has undergone cholestyramine washout at least 30 days prior to day 1.
• •* Certolizumab (Cimzia®) and abatacept (Orencia®) within 90 days prior to day 1.
• •* Rituximab (Rituxan®) or any other antiCD20 antibody, and cyclophosphamide within 180 days prior to day 1.
• •* Treatment with any other conventional disease modifying antirheumatic drugs (DMARDs), or treatment with any other biologics not previously noted within 28 days or 5 half-lives, whichever is longer, prior to day 1.
• •Subject has participated in a previous clinical study with treatment with ASP5094 or has participated in another dose cohort of the current trial.
• •Subject has previously received an experimental agent within 28 days or 5 half-lives, whichever is longer, prior to day 1.
• •Subject has had any significant blood loss, donated 1 unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to day 1.
• •Subject had surgery or has a planned elective surgery (including oral surgery) within 1 month prior to screening and 3 months after last study drug administration.
• •Subject has a wound that is currently healing.
• •Subject has any other condition, which in the opinion of the investigator, precludes the subject's participation in the trial.
• •Subject is an employee of the Astellas group or vendors involved in the study.