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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT04115423
Date of registration: 02/10/2019
Prospective Registration: Yes
Primary sponsor: Sungkyunkwan University
Public title: A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
Scientific 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
Date of first enrolment: April 1, 2020
Target sample size: 9508
Recruitment status: Active, not recruiting
Study type:  Observational
Study design:   
Countries of recruitment
Korea, Republic of
Name:     Ju-Young Shin, Ph.D
Affiliation:  Sungkyunkwan University
Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: Tocilizumab
Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)
Primary Outcome(s)
Hazard ratio for serious infections [Time Frame: January 2013 to December 2018]
Secondary Outcome(s)
Hazard ratio for six subdivided groups of serious infections by organ class [Time Frame: January 2013 to December 2018]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ministry of Food and Drug Safety, Korea
Ethics review
Results available:
Date Posted:
Date Completed:
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