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

NCT04115423 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 9508

Last updated 2020-09-10

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Tocilizumab

A humanized monoclonal antibody against the interleukin-6 receptor, which is mainly for the treatment of rheumatoid arthritis.

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.

Sponsors & Collaborators

  • Ministry of Food and Drug Safety, Korea

    collaborator OTHER_GOV

  • Sungkyunkwan University

    lead OTHER

Principal Investigators

  • Ju-Young Shin, Ph.D · Sungkyunkwan University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2021-10-01
Completion
2021-10-01
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04115423 on ClinicalTrials.gov