Trials / Unknown
UnknownNCT04384068
The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis
The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis in Real-World Clinical Setting
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,500 (estimated)
- Sponsor
- Peking Union Medical College Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2018-12-27
- Primary completion
- 2021-01-31
- Completion
- 2022-01-31
- First posted
- 2020-05-12
- Last updated
- 2020-05-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04384068. Inclusion in this directory is not an endorsement.