Conditions: Arthritis, Rheumatoid
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 645
Healthy volunteers: no

Brief summary:
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.

Detailed description:

Arms:
arm 1: one injection every 2 weeks for 48 weeks (25 injections in total) arm 2: one injection every 2 weeks for 48 weeks (25 injections in total)

Interventions: intervention 1: BI 695501 intervention 2: US-licensed Humira®
Intervention descriptions: intervention 1: BI 695501, every two weeks for 48 weeks (25 injections in total) intervention 2: one injection every 2 weeks for 48 weeks (25 injections in total)

Protocol document: