Arthritis Clinical Trials

This multi-center, randomized, double-blind, placebo-controlled, multiple dose, parallel, multiple dose level design study will enroll approximately 40 subjects with lupus arthritis, divided into two cohorts. Cohort 1 will consist of twenty subjects (n=20) randomized (1:1) to receive AMG 557 (210 mg dose) or matching placebo. Cohort 2, will consist of twenty subjects (n=20) randomized (1:1) to receive AMG 557 (210 mg or 140 mg dose) or matching placebo. The proportion of subjects assigned to 210 mg or 140 mg in Cohort 2 will be determined by an unblinded interim analysis by an independent team will be conducted following after all subjects in Cohort 1 have been enrolled. Based on this unblinded interim analysis, the number of subjects to be allocated to 210 mg and/or 140 mg for Cohort 2 may be adjusted maintaining total number of subjects enrolled in the study at 40 according to the pre-specified decision criteria. Enrollment of Cohort 1 (210 mg or placebo) will be completed before enrollment of Cohort 2 (210 mg or 140 mg or placebo) is initiated. An additional 12 subjects (in an allocation ratio of 1 AMG 557: 1 placebo) may be enrolled into the study based on emerging PK and PD data, but will not exceed 210 mg.