A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab
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|ClinicalTrials.gov Identifier: NCT04115423|
Recruitment Status : Active, not recruiting
First Posted : October 4, 2019
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment|
|Infection Rheumatoid Arthritis||Drug: Tocilizumab Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)|
|Study Type :||Observational|
|Actual Enrollment :||9508 participants|
|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|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||October 1, 2021|
Patients over 18 years of age with a diagnosis of RA (ICD-10 codes: M05-06) and receiving tocilizumab at least once from January 2013 to December 2018. Tocilizumab initiators are required to have no record of tocilizumab within 1 year prior to the first prescription of tocilizumab.
A humanized monoclonal antibody against the interleukin-6 receptor, which is mainly for the treatment of rheumatoid arthritis.
Other Name: ACTEMRA
Tumor necrosis factor inhibitors (TNFi) users
Patients over 18 years of age with a diagnosis of RA (ICD-10 codes: M05-06) and receiving TNFi at least once from January 2013 to December 2018. TNFi users will be patients who had no record of tocilizumab and given specific TNFi during 1 year before the first prescription of TNFi.
Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)
Tumor Necrosis Factor inhibitors (TNFi) are a group of medicines that suppresses the physiologic response to TNF, a protein involved in early inflammatory events. We will include etanercept, infliximab, adalimumab, and golimumab as TNFis since these drugs are commercialized in Korea.
Other Name: ENBREL, REMICADE, HUIMIRA, and SIMPONI
- Hazard ratio for serious infections [ Time Frame: January 2013 to December 2018 ]The ratio of the hazard rates of the serious infections in tocilizumab initiators vs. TNFi users
- Hazard ratio for six subdivided groups of serious infections by organ class [ Time Frame: January 2013 to December 2018 ]The ratio of the hazard rates of six subdivided organ-specific serious infections (respiratory tract, gastrointestinal tract, urological and gynecological infections, skin and subcutaneous tissue, sepsis, and others) in tocilizumab initiators vs. TNFi users
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115423
|Korea, Republic of|
|Suwon, Gyeonggi-do, Korea, Republic of, 16419|
|Principal Investigator:||Ju-Young Shin, Ph.D||Sungkyunkwan University|