Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis

Inclusion criteria

• Male or female; age 18 to 75 years
• Active RA for at least 6 months
• Active disease defined by having equal to or greater than 6 swollen joints and 6 tender joints, based on a 28 joint count
• On stable doses and regimen of allowed RA medications
• Currently receiving at least 10 mg of methotrexate a week. Patients unable to tolerate doses greater than 10 mg may also be eligible for enrollment.

Exclusion criteria

• Diagnosis of Felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic disease
• Any surgical procedure within 30 days of Screening or likely to need joint or tendon surgery or other surgical procedure during the study
• Intra-articular or intra-muscular corticosteroids within 60 days prior to dosing
• Previous treatment with any biologic response modifying agent for RA within 90 days or 5 half-lives, whichever is greater, prior to screening
• Previous treatment with rituximab at any time
• Use of corticosteroid therapy equivalent to an average daily dose of >10 mg of prednisone
• Any Screening laboratory values that are out of allowed reference ranges
• Inability to comply with protocol or study procedures
• Any other significant illness or condition that may adversely affect the subjects participation in the study