The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis

  • STATUS
    Recruiting
  • participants needed
    2500
  • sponsor
    Peking Union Medical College Hospital
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Updated on 16 February 2024
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arthritis
tocilizumab
actemra

Summary

The aim of this study is to investigate the safety and effectiveness of tocilizumab (Actemra) using Chinese Rheumatology Information Platform (CRIP) on Chinese Rheumatology Data Centre (CRDC, http://www.crdc.org.cn/) in Chinese RA patients.

Description

Tocilizumab (Actemra) is a humanized monoclonal antibody targeting the human IL-6 receptor, which inhibits the binding of this cytokine to its receptor. It is the first monoclonal antibody developed for RA treatment with this mechanism of action and has been approved by regulatory authorities in China since 2013. Data from five phase III studies with over 4000 recruited patients have shown that tocilizumab at a dose of 8 mg/kg, in combination with methotrexate/DMARDs or as monotherapy, can produce a quick and clinically relevant improvement in RA signs and symptoms, health status, and prevent joint damage, for both patients who have not been previously treated with and refractory to methotrexate, other DMARDs or anti-TNF agents. However, in real-world clinical setting, the safety profile and treatment pattern with regard to the persistence on tocilizumab and the efficacy are not clear in China. The aim of this study is to investigate the safety and effectiveness of tocilizumab using Chinese Rheumatology Information Platform (CRIP) on Chinese Rheumatology Data Centre (CRDC, http://www.crdc.org.cn/) in Chinese RA patients.

Details
Condition Rheumatoid Arthritis, Rheumatoid Arthritis
Age 18years - 100years
Clinical Study IdentifierNCT04384068
SponsorPeking Union Medical College Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients at least 18 years of age
Patients with a diagnosis of RA according to the revised (2010) ACR criteria
Patients per treating physician's judgment to treat with Tocilizumab
Signed written informed consent

Exclusion Criteria

Patients are receiving or have received any investigational agent 4 weeks (or 5 half-lives of investigational agent, whichever is longer) prior to enrollment of this study
Subjects with contra-indications to Tocilizumab therapy as detailed in the label (with known hypersensitivity to Tocilizumab or accessories; or with active infections.)
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