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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT04115423 |
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Date of registration:
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02/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
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Scientific title:
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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 |
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Date of first enrolment:
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April 1, 2020 |
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Target sample size:
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9508 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04115423 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Ju-Young Shin, Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sungkyunkwan University |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Infection
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Rheumatoid Arthritis
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Intervention(s)
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Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)
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Drug: Tocilizumab
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Primary Outcome(s)
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Hazard ratio for serious infections
[Time Frame: January 2013 to December 2018]
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Secondary Outcome(s)
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Hazard ratio for six subdivided groups of serious infections by organ class
[Time Frame: January 2013 to December 2018]
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Secondary ID(s)
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SKKU-2019-TCZ
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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