A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Trial Profile

A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade in Subjects with Moderate to Severe Rheumatoid Arthritis despite Methotrexate Therapy

Completed
Phase of Trial: Phase III

Latest Information Update: 08 Nov 2017

At a glance

  • Drugs Infliximab (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Sponsors Samsung Bioepis
  • Most Recent Events

    • 08 Nov 2017 Results assessing disease activity at weeks 14, 30 and 54 presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 01 Nov 2017 Results assessing PK profiles of SB2 in healthy subjects and patients with rheumatoid arthritis using patient data from NCT01936181 and NCT01922336 trials presented at the 25th United European Gastroenterology Week
    • 17 Oct 2017 Results of transition period (n=396) published in the Annals of the Rheumatic Diseases
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