Lead Sponsor

Lexicon Pharmaceuticals

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

•Males and females aged 18-75 years old
•Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria
•Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level \> upper limit of normal
•Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks prior to Day 1
•Ability to provide written informed consent

•RA diagnosis prior to 16 years of age (Juvenile RA)
•Lack of response to \>3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to \>1 biologic DMARD
•Use of DMARDs other than MTX within 12 weeks prior to Day 1
•Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1
•Blood donation or receipt of live vaccine within 4 weeks prior to Day 1
•Major surgical procedure within 8 weeks prior to Day 1
•Any systemic inflammatory condition, recurrent infection, or current infection other than onychomycosis
•History of cancer within 5 years prior to Day 1
•Presence of hepatic or biliary disease
•History of tuberculosis
•History of human immunodeficiency virus (HIV)

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