A Study to Compare Efficacy and Safety of CT-P47 and RoActemra in Patients With Rheumatoid Arthritis

Launched by CELLTRION · Aug 3, 2022

Keywords

ClinConnect Summary

CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that is being developed as a similar biological medicinal product to RoActemra/Actemra. The purpose of this study is to demonstrate similar efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is male or female aged 18 to 75 years old, both inclusive.
• • 2. Patient has had a diagnosis of RA according to the 2010 ACR/EULAR classification criteria for at least 24 weeks prior to the first administration of the study drug.
• Exclusion Criteria:
• • 1. Patient who has previously received investigational or licensed product; targeted synthetic DMARD(s) (e.g., tofacitinib, baricitinib) for the treatment of RA and/or an interleukin-6 (IL-6) inhibitor for any purposes.
• • 2. Patient who has previously received more than 1 biologic agents approved for the treatment of RA.
• • 3. Patient who has allergies to any of the excipients of study drug or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.