Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients

A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)

Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients

A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (anti-IL-6)

Inclusion Criteria:

• Active Rheumatoid Arthritis (RA) for 6 months or more.
• Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
• Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
• Males, unless surgically sterile, must use 2 effective methods of birth control from Day 1 through follow-up.

Exclusion Criteria:

• History or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
• History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
• Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
• Current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
• Intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.