Status:
UNKNOWN
A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
Lead Sponsor:
Sungkyunkwan University
Collaborating Sponsors:
Ministry of Food and Drug Safety, Korea
Conditions:
Infection
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
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 th...
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...
Eligibility Criteria
Inclusion
- Individuals who had a diagnosis of rheumatoid arthritis (ICD-10 codes: M05-06) between 2013 and 2018
Exclusion
- Individuals less than 18 years of age
- Having no records of prescription of tocilizumab or TNFi at least once between 2013 and 2018
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
9508 Patients enrolled
Trial Details
Trial ID
NCT04115423
Start Date
April 1 2020
End Date
October 1 2021
Last Update
September 10 2020
Active Locations (1)
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1
Sungkyunkwan University
Suwon, Gyeonggi-do, South Korea, 16419