Arthritis, RheumatoidNCT04384068
The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis
An observational study of Arthritis, Rheumatoid, run by Peking Union Medical College Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Arthritis, Rheumatoid
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 27 Dec 2018to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Jiuliang zhao, 010-69158793, zjlpumc@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, tocilizumab, safety
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chinese RA patients | Chinese RA patients who used tocilizumab in real world clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 52
Safety endpoints change from baseline to week 52
Incidence and severity of unexpected AE/ adverse drug reaction（ADR）in RA patients
Measured: Baseline, Week 52
Secondary outcomes (2)
Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.
Effectiveness endpoints
Measured: 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).
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2020
- Study start27 Dec 2018
- Primary completion31 Jan 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04384068
- Sponsor's protocol ID
- HS-1383
- Status last verified
- Apr 2020
- First submitted
- 17 Oct 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Tocilizumab in Rheumatoid Arthritis in Real-World Clinical Setting
- ClinicalTrials.gov ID
- NCT04384068
- Acronym / sponsor ID
- HS-1383
- Conditions
- Arthritis, Rheumatoid
- Keywords
- Rheumatoid Arthritis, tocilizumab, safety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 27 Dec 2018 (actual)
- Primary completion
- 31 Jan 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 12 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chinese RA patients | – | –Chinese RA patients who used tocilizumab in real world clinical practice |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety endpoints change from baseline to week 52
Time frame: 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.
Safety endpoints change from baseline to week 52
Time frame: Baseline, Week 52
Incidence and severity of unexpected AE/ adverse drug reaction（ADR）in RA patients
2 secondary outcomes
Proportion of RA patients achieving treatment target measured by DAS28, CDAI, SDAI.
Time frame: Baseline, Week 52
Mean changes from baseline in Health Assessment Questionnaire Disability Index score
Time frame: Baseline, Week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Peking Union Medical College Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact jiuliang Zhao, MD (+861069158793, zjlpumc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety endpoints change from baseline to week 52 (time frame: Baseline, Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2020.