NCT02137226

BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 645 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Rheumatoid

Interventions

Type	Name	Description
DRUG	BI 695501	BI 695501, every two weeks for 48 weeks (25 injections in total)
DRUG	US-licensed Humira®	one injection every 2 weeks for 48 weeks (25 injections in total)

Timeline

• Start date: 2015-01-26
• Primary completion: 2016-03-03
• Completion: 2016-10-18
• First posted: 2014-05-13
• Last updated: 2018-01-19
• Results posted: 2017-12-08

Locations

138 sites across 15 countries: United States, Bulgaria, Chile, Estonia, Germany, Hungary, Malaysia, New Zealand, Poland, Russia, Serbia, South Korea, Spain, Thailand, Ukraine