Trial Profile
A Randomised, Double-Blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 24 Dec 2021
Price :
$35
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At a glance
- Drugs Etanercept (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Sponsors Samsung Bioepis
- 08 Oct 2021 Results of meta-analysis of 3 randomized controlled trials (NCT01270997; NCT01895309 & NCT02357069) assessing efficacy and safety of etanercept biosimilars vs. etanercept originators in patients with active rheumatoid arthritis despite treatment with methotrexate, published in the International Journal of Clinical Pharmacology and Therapeutics.
- 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).