A Retrospective Cohort Study on the Risk of Serious Infections in Rheumatoid Arthritis Patients Receiving Tocilizumab

Sponsor
Sungkyunkwan University
Study ID
NCT04115423
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab — DRUG
    A humanized monoclonal antibody against the interleukin-6 receptor, which is mainly for the treatment of rheumatoid arthritis.
  • Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab) — DRUG
    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.

Study Details

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.

Key Dates

Start date
Apr 1, 2020
Status verified
Sep 2020
Primary completion
Oct 1, 2021
Completion
Oct 1, 2021

Study Design

Enrollment
9,508 participants (actual)

Arms

  • Arm: Tocilizumab initiators
    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.
  • Arm: 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.

Primary Outcome Measure

Hazard ratio for serious infections [ Time Frame: January 2013 to December 2018 ]

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