The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis

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

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.

Study Overview

• Status: Unknown
• Conditions: Arthritis, Rheumatoid

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 Type: Observational
• Enrollment (Anticipated): 2500

Contacts and Locations

• Study Contact: Name: jiuliang Zhao, MD; Phone Number: +861069158793; Email: zjlpumc@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100005
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Jiuliang zhao; Phone Number: 010-69158793; Email: zjlpumc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Approximately 2500 participants will be enrolled in this study from Approximately 50 investigational centers in China. The study population will include patients with RA, according to 2010 ACR criteria, in whom the treating physician has made the decision to treat with Tocilizumab. Furthermore, patients must have given their informed consent and must not meet any of the exclusion criteria.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Chinese RA patients; Chinese RA patients who used tocilizumab in real world clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.	Effectiveness endpoints	Baseline, Week 52
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients still on TCZ treatment after treatment initiation.	Exposure endpoints	Baseline, Week 52
Mean dose of tocilizumab	Exposure endpoints	Baseline, Week 52
Mean duration (weeks) of tocilizumab treatment measured by the weeks of continuous tocilizumab administrated, regardless of dose reduction	Exposure endpoints	Baseline, Week 52
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
Mean dose interval as measured by weeks between tocilizumab infusions.	Exposure endpoints	Baseline, Week 52
Proportion of patients discontinued from tocilizumab for safety and efficacy.	Exposure endpoints	Baseline, Week 52

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2018
• Primary Completion (Anticipated): January 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: May 9, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: safety; Rheumatoid Arthritis; tocilizumab
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: HS-1383

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No