Arthritis, Rheumatoid Clinical Trial
Official title:
Efficacy, Safety and Immunogenicity of BI 695501 Versus Adalimumab in Patients With Active Rheumatoid Arthritis: a Randomized, Double-blind,Parallel Arm, Multiple Dose, Active Comparator Trial
Primary Objective:
The primary objective of this trial is to establish an equivalence in efficacy between BI
695501 and US-licensed Humira® in patients with active Rheumatoid arthritis based on a
statistical comparison of the proportion of patients meeting American College of Rheumatology
20% (ACR20) response rate at Week 12 and ACR20 response rate at Week 24 between BI 695501 and
US-licensed Humira®.
Secondary Objectives:
The secondary objectives of this trial are to compare the efficacy, safety and immunogenicity
of BI 695501 and US-licensed Humira® in patients with active RA including those undergoing
the transition from US-licensed Humira® to BI 695501 after 24 weeks.
n/a
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