NCT05725434

A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Active Rheumatoid Arthritis

A Single-arm, Open-label, Multiple-dose, Phase 3 Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P47 in Patients With Moderate to Severe Active Rheumatoid Arthritis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 3 study to evaluate the usability of the CT-P47 auto-injector 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 evaluate the usability of the CT-P47 auto-injector in patients with moderate to severe rheumatoid arthritis when co-administered with methotrexate.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	CT-P47 AI (tocilizumab)	CT-P47 (162 mg/0.9 mL) by subcutaneous (SC) injection via autoinjector (AI) at Week 0 and Week 2
BIOLOGICAL	CT-P47 PFS (tocilizumab)	CT-P47 (162 mg/0.9 mL) by SC injection via pre-filled syringe from Week 4 every other week or weekly (based on the clinical response by investigator's discretion) up to Week 10

Timeline

• Start date: 2023-02-06
• Primary completion: 2023-04-01
• Completion: 2023-07-31
• First posted: 2023-02-13
• Last updated: 2023-02-16