The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis

Arthritis, Rheumatoid Clinical Trial

Official title:

The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis in Real-World Clinical Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04384068
• Other study ID #: HS-1383
• Status: Recruiting
• Start date: December 27, 2018
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2020
• Source: Peking Union Medical College Hospital
• Contact: jiuliang Zhao, MD
• Phone: +861069158793
• Email: zjlpumc[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patients still on TCZ treatment after treatment initiation.	Exposure endpoints	Baseline, Week 52
Other	Mean dose of tocilizumab	Exposure endpoints	Baseline, Week 52
Other	Mean duration (weeks) of tocilizumab treatment measured by the weeks of continuous tocilizumab administrated, regardless of dose reduction	Exposure endpoints	Baseline, Week 52
Other	Proportion of patients with dose decrease, dose discontinuation (subject stopped Tocilizumab treatment and did not take any administration of tocilizumab till the end of study) and dose interruption and the possible reason.	Exposure endpoints	Baseline, Week 52
Other	Mean dose interval as measured by weeks between tocilizumab infusions.	Exposure endpoints	Baseline, Week 52
Other	Proportion of patients discontinued from tocilizumab for safety and efficacy.	Exposure endpoints	Baseline, Week 52
Primary	Safety endpoints change from baseline to week 52	Incidence of AEs, SAEs and AESIs with severity determined through use of NCI-CTCAE version 4.03 in full RA population, as well as the causalities between AEs and Tocilizumab.	Baseline, Week 52
Primary	Safety endpoints change from baseline to week 52	Incidence and severity of unexpected AE/ adverse drug reaction(ADR)in RA patients	Baseline, Week 52
Secondary	Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.	Effectiveness endpoints	Baseline, Week 52
Secondary	Mean changes from baseline in Health Assessment Questionnaire Disability Index score	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).	Baseline, Week 52