NCT04115423

A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

A Retrospective Cohort Study to Examine the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab Compared With Tumor Necrosis Factor Inhibitors Using the National Health Insurance Database

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 9,508 (actual)
• Sponsor: Sungkyunkwan University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether the risk of serious infections in rheumatoid arthritis patients with tocilizumab is higher than in those with tumor necrosis factor inhibitors using the nationwide real-world data.

Detailed description

This observational, retrospective cohort study using the Korean National Health Insurance (NHI) data will evaluate whether the risk of serious infections (SIs) in rheumatoid arthritis patients treated with tocilizumab is higher than in those with tumor necrosis factor inhibitors. We will compare incidence rates between two groups and estimate relative risks of SIs in tocilizumab users using the time-dependent Cox proportional hazard regression. Various covariates potentially related to RA severity and occurrence of infection will be assessed and used for adjustment.

Conditions

• Infection
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	A humanized monoclonal antibody against the interleukin-6 receptor, which is mainly for the treatment of rheumatoid arthritis.
DRUG	Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)	Tumor Necrosis Factor inhibitors (TNFi) are a group of medicines that suppresses the physiologic response to TNF, a protein involved in early inflammatory events. We will include etanercept, infliximab, adalimumab, and golimumab as TNFis since these drugs are commercialized in Korea.

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-10-01
• Completion: 2021-10-01
• First posted: 2019-10-04
• Last updated: 2020-09-10

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study