The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis
1 other identifier
observational
2,500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2017
CompletedStudy Start
First participant enrolled
December 27, 2018
CompletedFirst Posted
Study publicly available on registry
May 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2022
CompletedMay 12, 2020
April 1, 2020
2.1 years
October 17, 2017
May 9, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.
Baseline, Week 52
Mean changes from baseline in Health Assessment Questionnaire Disability Index score
Baseline, Week 52
Other Outcomes (6)
Proportion of patients still on TCZ treatment after treatment initiation.
Baseline, Week 52
Mean dose of tocilizumab
Baseline, Week 52
Mean duration (weeks) of tocilizumab treatment measured by the weeks of continuous tocilizumab administrated, regardless of dose reduction
Baseline, Week 52
- +3 more other outcomes
Study Arms (1)
Chinese RA patients
Chinese RA patients who used tocilizumab in real world clinical practice
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
May 12, 2020
Study Start
December 27, 2018
Primary Completion
January 31, 2021
Study Completion
January 31, 2022
Last Updated
May 12, 2020
Record last verified: 2020-04