Efficacy, Pharmacokinetics, and Safety of BI 695500 in Patients With Rheumatoid Arthritis
Status:
Terminated
Trial end date:
2016-10-12
Target enrollment:
Participant gender:
Summary
The primary objectives of this trial are (1) To show PK (Pharmacokinetic) similarity of BI
695500 to rituximab. (2)To establish statistical equivalence of efficacy of BI 695500 and
rituximab, in patients with moderately to severely active RA (Rheumatoid Arthritis), based on
the change in Disease Activity Score 28 (DAS28) score measured at 24 weeks compared to
Baseline and the American College of Rheumatology 20% (ACR20) response rate at Week 24.