The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis

• Conditions: Arthritis, Rheumatoid

• Registration Number: NCT04384068
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2017-10-17
• Study Start: 2018-12-27
• Status Verified: 2020-04
• Study First Submitted QC: 2020-05-09
• Last Update Submitted: 2020-05-09
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2500

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.).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety endpoints change from baseline to week 52	Baseline, Week 52	Incidence and severity of unexpected AE/ adverse drug reaction（ADR）in RA patients

Secondary Outcome Measures

Name	Time	Method
Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.	Baseline, Week 52	Effectiveness endpoints
Mean changes from baseline in Health Assessment Questionnaire Disability Index score	Baseline, Week 52	Effectiveness endpoints ( It consists of 20 questions referring to 8 component sets. The questionnaire will be scored based on the instructions from the Stanford University Medical Center and higher scores mean a worse outcome).

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China