A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 4540
Summary
- Conditions
- Infection
- Rheumatoid Arthritis
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Retrospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 inc...
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.
Tracking Information
- NCT #
- NCT04115423
- Collaborators
- Ministry of Food and Drug Safety, Korea
- Investigators
- Principal Investigator: Ju-Young Shin, Ph.D Sungkyunkwan University
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