Clinical trial NCT04115423: A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infection
Rheumatoid Arthritis
Keywords: Tocilizumab
Serious Infection
Rheumatoid Arthritis
Tumor necrosis factor inhibitors
Lead sponsor: Sungkyunkwan University
Sponsor class: OTHER
Collaborators: name: Ministry of Food and Drug Safety, Korea
First posted: 2019-10-04
Enrollment: 9508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had a diagnosis of rheumatoid arthritis (ICD-10 codes: M05-06) and received tocilizumab or TNFi (etanercept, infliximab, adalimumab, and golimumab) at least once between 2013 and 2018.

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Individuals who had a diagnosis of rheumatoid arthritis (ICD-10 codes: M05-06) between 2013 and 2018

Exclusion Criteria:

* Individuals less than 18 years of age
* Having no records of prescription of tocilizumab or TNFi at least once between 2013 and 2018

Primary outcomes:
measure: Hazard ratio for serious infections
timeFrame: January 2013 to December 2018
Secondary outcomes:
measure: Hazard ratio for six subdivided groups of serious infections by organ class
timeFrame: January 2013 to December 2018
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Sungkyunkwan University
state: Gyeonggi-do
Study officials:
affiliation: Sungkyunkwan University
name: Ju-Young Shin, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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