Clinical Trials

Date: 2016-10-26

Type of information: Results

phase: 3

Announcement: results

Company: Boehringer Ingelheim (Germany)

Product: BI 695501 (biosimilar version of Humira® (adalimumab))

Action mechanism: biosimilar/monoclonal antibody/TNF alpha inhibitor

Disease: rheumatoid arthritis

Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases

Country: Bulgaria, Chile, Estonia, Germany, Hungary, Republic of Korea, Malaysia, New Zealand, Poland, Russian Federation, Serbia, Spain, Thailand, Ukraine, Argentina, Colombia, Mexico, Philippines, South Africa, USA

Trial details: The primary objective of this trial is to establish an equivalence in efficacy between BI 695501 and US-licensed Humira® in patients with active rheumtoid 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-lisensed Humira® in patients with active rheumtoid arthritis including those undergoing the transition from US-licensed Humira® to BI 695501 after 24 weeks. (NCT02137226)

Latest news:

• • On October 26, 2016, Boehringer Ingelheim announced top-line results from the pivotal Phase III clinical study of BI 695501, a biosimilar candidate to U.S.-licensed Humira® and EU approved Humira® (adalimumab). BI 695501 met the clinical study primary efficacy endpoint to establish equivalence with Humira® in patients with active rheumatoid arthritis (RA). The secondary endpoints for efficacy, safety and immunogenicity of BI 695501 vs. Humira®, were also met. The study was a randomized, double-blind, parallel arm, multiple dose, active comparator studyi in 645 patients diagnosed with moderate to severe active rheumatoid arthritis who were treated with methotrexate. Each participant was randomized to receive either BI 695501 or Humira® every two weeks for 48 weeks. The primary objective of this clinical study was to establish statistical equivalence in efficacy between BI 695501 and Humira® in patients with active RA as measured by the proportion of patients meeting ACR20 (American College of Rheumatology 20) criteria at Week 12 and at Week 24 compared to baseline. The secondary objectives of this clinical study were to compare other efficacy parameters (DAS28)iii, safety and immunogenicity of BI 695501 and Humira®. Results from this clinical study will be published and presented at future medical congresses.

Is general: Yes