The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Arthritis, Rheumatoid

Study type: Observational

Funder types: Other

Identifiers

NCT04384068

HS-1383

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.).

Trial design

2,500 participants in 1 patient group

Chinese RA patients

Description:

Chinese RA patients who used tocilizumab in real world clinical practice