Arthritis, Rheumatoid
Conditions
Keywords
Rheumatoid Arthritis, tocilizumab, safety
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.
Interventions
None listed
Sponsors
Peking Union Medical College Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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.).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety endpoints change from baseline to week 52 | Baseline, 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline, Week 52 | Exposure endpoints |
| Proportion of patients still on TCZ treatment after treatment initiation. | Baseline, Week 52 | Exposure endpoints |
| Proportion of patients discontinued from tocilizumab for safety and efficacy. | Baseline, Week 52 | Exposure endpoints |
| Mean dose interval as measured by weeks between tocilizumab infusions. | Baseline, Week 52 | Exposure endpoints |
| Mean dose of tocilizumab | Baseline, Week 52 | Exposure endpoints |
| Mean duration (weeks) of tocilizumab treatment measured by the weeks of continuous tocilizumab administrated, regardless of dose reduction | Baseline, Week 52 | Exposure endpoints |
Countries
China
Contacts
Primary Contactjiuliang Zhao, MD
Outcome results
None listed