Rheumatoid Arthritis Memory B Cells and Abatacept

Inclusion Criteria

• Signed Written Informed Consent
• Subject is willing to participate in the study and has signed the informed consent.
• Target Population
• Men or women (not nursing or pregnant) over 18 years old who have active Rheumatoid Arthritis, defined as symptoms of Rheumatoid Arthritis prior to screening and have satisfied the American College of Rheumatology/ European League Against Rheumatism 2010 criteria for the classification of Rheumatoid Arthritis prior to signing t the informed consent.
• Subjects must have a Disease Activity Score 28-joint count C reactive protein (CRP) or Clinical Disease Activity Index (CDAI) assessment at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal joints) at screening and at Day 1. Patients must have at least moderate disease activity {CDAI>16); Disease Activity Score and C-reactive protein test (DAS28CRP (>4.0 )].
• Subjects must be naive to biologic Disease-modifying antirheumatic drugs (DMARDs)
• Subjects must be naive to targeted synthetic DMARDs such as tofacitinib, baricitinib, and investigational therapies for RA.
• Subjects receiving oral corticosteroids must be on a stable dose and at the equivalent of 10 mg prednisone daily for at least 4 weeks. Subjects may not receive an intravenous (IV), intramuscular (IM) or intra-arterial (IA) administration of a corticosteroid within 4 weeks prior to screening visit or initiation of therapy
• Patients with prior (including discontinued) therapy with Methotrexate and/or Hydroxychloroquine are permitted as long as they meet other inclusionary criteria.
• Subjects must have a DAS28CRP and Clinical Disease Activity Index (CDAI) at screening and have at least 3 tender and at least 3 swollen joints (excluding distal interphalangeal joints) at screening and at Day 1.
• Age and Reproductive Status
• Men and women, age's 18 years (or age of majority)
• Women of childbearing potential (WOCBP) must have a negative serum or urine
• pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within
• 24 hours prior to the start of study drug.
• Women must not be breastfeeding and must agree not to breastfeed during the study and for 100 days thereafter
• WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 5 half-lives of study drug (70 days) plus 30 days (duration of ovulatory cycle) for a total of 100 days post-treatment completion.
• Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug, plus 5 half- lives of the study drug (70 days) plus 90 days (duration of sperm turnover) for a total of 160 days post-treatment completion.
• Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However they must still undergo pregnancy testing as described in this section. Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
• Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of
• Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics.
• Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy. 3. Subjects with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.). 4. Subjects with any history of infection of a joint prosthesis or artificial joint.
• Subjects who have a history of systemic fungal infections (such as histoplasmosis, blastomycosis, or coccidiomycosis).