Usability of an AI for M923 in Subjects With Moderate to Severe RA

Exclusion Criteria

• •1. Prior use of systemic tumor necrosis factor (TNF) inhibitor therapy.
• •2. Prior use of rituximab
• •3. Prior use of abatacept, tocilizumab and tofacitinib within 4 weeks prior to Screening
• •4. Current use of a conventional disease modifying anti-rheumatic drugs (DMARD) other than the following: methotrexate orally (≤25 mg/day), hydroxychloroquine (≤400 mg/day) or sulfasalazine (≤3 g/day)) at a stable dose for at least 4 weeks prior to Screening. If discontinued, methotrexate, hydroxychloroquine, and sulfasalazine must have been discontinued at least 4 weeks prior to Baseline. No other conventional DMARDs are permitted and no combination therapy is permitted.
• •5. Prior use of cytotoxic or alkylating agents or immunosuppressants must have been discontinued for at least 90 days prior to Baseline
• •6. Current use of oral corticosteroids at a dose \>10 mg/day prednisone or equivalent or change of dose within 2 weeks prior to Screening
• •7. Current use of more than 1 nonsteroidal anti-inflammatory drug.
• •8. Prior use of injectable corticosteroids (intramuscular \[IM\], intra-articular \[IA\], or intravenous \[IV\]) within 6 weeks prior to Baseline
• •9. Prior or current use of other self-injected drugs, eg, insulin
• •10. All other prior non-RA concomitant treatments must be on a stable dose for at least 4 weeks before Baseline
• •11. Meets Class IV Steinbrocker criteria for disability/activities of daily living
• •12. Laboratory abnormalities at Screening deemed clinically significant by the Investigator and/or Sponsor.
• •13. Presence of fibromyalgia, another autoimmune rheumatologic illness or inflammatory arthritis, eg, systemic lupus erythematosus, gout. The presence of secondary Sjogren's syndrome is permitted.
• •14. Joint surgery within the last 8 weeks prior to Screening
• •15. Severe, progressive, or uncontrolled renal, hepatic, metabolic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac or neurologic disease, including pleural effusions or ascites, which in the opinion of the Investigator would preclude the participant from adhering to or completing the study or where participation in the study exposes the participant to unfavorable benefit/risk
• •16. History or presence of signs and/or symptoms or a diagnosis of a demyelinating disorder
• •17. History or presence of Class III or IV New York Heart Association congestive heart failure
• •18. History or presence of symptoms suggestive of lymphoproliferative disorders, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma
• •19. Existing malignancy or history of any malignancy except adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ, with no more than 3 lifetime basal cell or squamous cell carcinomas
• •20. Chronic infections, recurrent infections (3 or more of the same infection requiring anti-infective treatment in any rolling 12-month period); any recent infection (ie, in the last 30 days) requiring hospitalization or any infection requiring parenteral anti-infective therapy within 30 days or oral infective therapies within 14 days of Baseline; herpes zoster within 6 months of Baseline or more than 2 lifetime episodes of herpes zoster; or history of systemic fungal infection or opportunistic infection (eg, coccidioidomycosis, histoplasmosis, toxoplasmosis)
• •21. History or presence of human immunodeficiency virus (HIV), Hepatitis B or C virus
• •22. History of active tuberculosis (TB) or untreated or inadequately treated latent TB.
• •23. Participant has been exposed to an investigational product (IP) within 30 days (or 5 half-lives) prior to enrollment, whichever is longer, or is scheduled to participate in another clinical study involving an IP or investigational device during the course of this study
• •24. Participant is a family member or employee of the Investigator or Baxalta or its partners