A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis
Phase of Trial: Phase III
Latest Information Update: 13 Jun 2018
At a glance
- Drugs Adalimumab (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Sponsors Samsung Bioepis
- 13 Jun 2018 Pooled analysis data from three phase 3 studies (NCT01895309,NCT01936181 and NCT02167139) presented in a Samsung Bioepis media release.
- 13 Jun 2018 According to a Samsung Bioepis media release, pooled analysis data from three phase 3 studies (NCT01895309,NCT01936181 and NCT02167139) will be presented at the Annual European Congress of Rheumatology (EULAR 2018).
- 13 Feb 2018 Results (n=542) assessing efficacy and comparable safety results of SB5 and reference adalimumab (ADA) in patients with moderate to severe rheumatoid arthritis, were published in the Arthritis and Rheumatology.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History