Study Complete
Sponsor ID
20101103
Safety Study of AMG 557 in Subjects With Lupus Arthritis
Study Details
This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.
Protocol Summary
Primary Outcome Measures
Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557.
Timeframe: 330 days, including a 21-day screening period
Lupus Arthritis Response Rate
Timeframe: Day 169
Secondary Outcome Measures
Proportion of subjects achieving a) one letter improvement; and b) ‘C’ or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group.
Timeframe: Day 169
Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.
Timeframe: Day 169
Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline.
Timeframe: Days 85-169
Proportion of subjects achieving reduction in and maintenance of prednisone (or its
Timeframe: Days 85-169
Physician Global Assessment of Disease Activity (PGADA).
Timeframe: 330 days, including a 21-day screening period
Subject Global Assessment of Disease Activity (SGADA).
Timeframe: 330 days, including a 21-day screening period
Serum PK profile of AMG 557 after multiple dose administrations.
Timeframe: 330 days, including a 21-day screening period
Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects
Timeframe: Day 29
Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.
Timeframe: Day 85 to Day 169
Locations
Location
Research Site
Danbury, CT, United States, 06810
Status
Completed
Location
Research Site
Manhasset, NY, United States, 11030
Status
Completed
Location
Research Site
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Status
Completed
Location
Research Site
Kuching, Sarawak, Malaysia, 93586
Status
Completed
Location
Research Site
San Leandro, CA, United States, 94578
Status
Completed
Location
Research Site
Odense, Denmark, 5000
Status
Completed
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