Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
Study Details
This trial is designed to determine what effects the human body has on the investigational medicine, ABP 798, and what effects the body has on the investigational medicine after you have been given it, and if this is comparable to what is seen for the licensed medicine, rituximab, in patients with moderate or severe RA.
This study will also assess if the investigational medicine is safe and effective in treating moderate or severe RA compared to the licensed medicine.
Protocol Summary
Area under the serum concentration-time curve (AUCinf)
Timeframe: Day 15
Maximum serum concentration (Cmax)
Timeframe: Day 15
ACR [American College of Rheumatology] improvement in core set measurements
Timeframe: Week 24
Disease Activity Score 28-CRP
Timeframe: Week 24
Subject incidence of adverse events and serious adverse events
Timeframe: Weeks 24 and 48
Incidence of anti-drug antibodies
Timeframe: Weeks 24 and 48
Pharmacodynamics (PD) endpoints will include the percent of subjects with complete depletion in CD19+ cell count
Timeframe: Days 1 to 3
AUC from time 0 on day 1 prior to the first infusion of the first dose to day 14 (AUC 0-14 day)
Timeframe: Day 1 to day 14
AUC from time 0 on day 1 prior to the first infusion of the first dose to week 12 (AUC 0-12 wk)
Timeframe: Day 1 to Week 12
Cmax
Timeframe: Day 1
Clinical significant changes in laboratory values
Timeframe: Weeks 24 and 48
Clinical significant changes in vital signs
Timeframe: Weeks 24 and 48
to demonstrate PK similarity between rituximab (US) and rituximab (EU) as
Timeframe: Day 15