At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating BI 695501 and US-licensed Humira® for Arthritis, Rheumatoid. Completed, enrolled 645 participants across 138 sites in 15 countries.
Detailed 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.
Study Details
Timeline
Interventions
BI 695501, every two weeks for 48 weeks (25 injections in total)
one injection every 2 weeks for 48 weeks (25 injections in total)