Clinical trial NCT04384068: The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis
Official title: The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis in Real-World Clinical Setting
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Arthritis, Rheumatoid
Keywords: Rheumatoid Arthritis
tocilizumab
safety
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.).

Primary outcomes:
measure: Safety endpoints change from baseline to week 52
timeFrame: Baseline, Week 52
measure: Safety endpoints change from baseline to week 52
timeFrame: Baseline, Week 52
Secondary outcomes:
measure: Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.
timeFrame: Baseline, Week 52
measure: Mean changes from baseline in Health Assessment Questionnaire Disability Index score
timeFrame: Baseline, Week 52
Other outcomes:
measure: Proportion of patients still on TCZ treatment after treatment initiation.
timeFrame: Baseline, Week 52
measure: Mean dose of tocilizumab
timeFrame: Baseline, Week 52
measure: Mean duration (weeks) of tocilizumab treatment measured by the weeks of continuous tocilizumab administrated, regardless of dose reduction
timeFrame: Baseline, Week 52
measure: 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.
timeFrame: Baseline, Week 52
measure: Mean dose interval as measured by weeks between tocilizumab infusions.
timeFrame: Baseline, Week 52
measure: Proportion of patients discontinued from tocilizumab for safety and efficacy.
timeFrame: Baseline, Week 52
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References: