Study Complete
Sponsor ID
20150196
Multiple Ascending Doses of Rozibafusp Alfa (AMG 570) in Adults With Rheumatoid Arthritis
Study Details
A study to evaluate safety and tolerability and characterize the pharmacokinetic (PK) profile of rozibafusp alfa following multiple dose administration in adults with rheumatoid arthritis (RA).
Protocol Summary
Primary Outcome Measures
Number of participants with treatment-emergent adverse events
Timeframe: 34 weeks
Number of participants with clinically significant changes in physical examinations
Timeframe: 34 weeks
Number of participants with clinically significant changes in vital signs
Timeframe: 34 weeks
Number of participants with clinically significant changes in laboratory safety tests
Timeframe: 34 weeks
Number of participants with clinically significant changes in electrocardiograms (ECGs)
Timeframe: 34 weeks
Secondary Outcome Measures
Serum PK parameter of maximum-observed concentration (Cmax)
Timeframe: 34 weeks
Serum PK parameter of time at Cmax [tmax]
Timeframe: 34 weeks
Serum PK parameter of area under the curve (AUC)
Timeframe: 34 weeks
Locations
Location
Altoona Center for Clinical Research
Duncansville, PA, United States, 16635
Status
Completed
Location
Pinnacle Research Group LLC
Anniston, AL, United States, 36207
Status
Completed
Location
Metroplex Clinical Research Center
Dallas, TX, United States, 75231
Status
Completed
Location
Charite Research Organisation GmbH
Berlin, Germany, 10117
Status
Completed