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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
Sponsor:
Collaborator:
Ministry of Food and Drug Safety, Korea
Information provided by (Responsible Party):
Ju-Young Shin, Sungkyunkwan University

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 the nationwide real-world data.

Condition or disease Intervention/treatment
Infection Rheumatoid Arthritis Drug: Tocilizumab Drug: Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)

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 with tocilizumab is higher than in those with tumor necrosis factor inhibitors. We will compare incidence rates between two groups and estimate relative risks of SIs in tocilizumab users using the time-dependent Cox proportional hazard regression. Various covariates potentially related to RA severity and occurrence of infection will be assessed and used for adjustment.

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Study Type : Observational
Actual Enrollment : 9508 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Drug: 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who had a diagnosis of rheumatoid arthritis (ICD-10 codes: M05-06) and received tocilizumab or TNFi (etanercept, infliximab, adalimumab, and golimumab) at least once between 2013 and 2018.
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

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Sungkyunkwan University
Suwon, Gyeonggi-do, Korea, Republic of, 16419
Sponsors and Collaborators
Sungkyunkwan University
Ministry of Food and Drug Safety, Korea
Investigators
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Principal Investigator: Ju-Young Shin, Ph.D Sungkyunkwan University
Publications:

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Responsible Party: Ju-Young Shin, Assistant Professor, Sungkyunkwan University
ClinicalTrials.gov Identifier: NCT04115423    
Other Study ID Numbers: SKKU-2019-TCZ
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ju-Young Shin, Sungkyunkwan University:
Tocilizumab
Serious Infection
Rheumatoid Arthritis
Tumor necrosis factor inhibitors
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Etanercept
Infliximab
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Dermatologic Agents