NCT05489224

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

A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of Two Intravenous Infusion Formulations of Tocilizumab (CT-P47 and RoActemra) When Co-administered With Methotrexate in Patients With Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 471 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 study to compare efficacy and safety of CT-P47 and RoActemra in patients with moderate to severe active rheumatoid arthritis.

Detailed description

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	CT-P47	CT-P47, 8 mg/kg (not exceeding 800 mg/dose) by intravenous (IV) infusion every 4 weeks (Q4W)
BIOLOGICAL	EU-approved RoActemra	EU-approved RoActemra, 8 mg/kg (not exceeding 800 mg/dose) by IV infusion Q4W

Timeline

• Start date: 2022-09-14
• Primary completion: 2023-06-29
• Completion: 2023-11-23
• First posted: 2022-08-05
• Last updated: 2024-10-08
• Results posted: 2024-10-08

Locations

1 site across 1 country: Poland

Regulatory

• FDA-regulated drug study