NCT05866614

A Study to Evaluate the Safety of Remsima® SC in the Treatment of RA, AS, PsA and Ps

An Observational, Prospective Cohort Study to Evaluate Safety of Remsima® Subcutaneous in Patients With Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 881 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an observational, prospective cohort study to evaluate the safety of Remsima® SC in the treatment of RA, AS, PsA and Ps.

Detailed description

CT-P13(Remsima®) is an IgG1 chimeric human-murine mAb biosimilar to Remicade® (infliximab, Janssen Biologics B.V.) developed by CELLTRION, Inc.The purpose of this study is to assess the safety of Remsima® Subcutaneous (SC) in Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA) and Psoriasis (Ps) patients by evaluation of adverse events of special interest (AESI)

Conditions

• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Psoriasis

Interventions

Type	Name	Description
DRUG	Remsima IV	Patient will be treated with Remsima IV as per the SmPC or
DRUG	Remsima SC	Patient will be treated with Remsima SC as per the SmPC

Timeline

• Start date: 2023-01-13
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2023-05-19
• Last updated: 2026-03-31

Locations

1 site across 1 country: France

Regulatory

• FDA-regulated drug study