Rheumatoid ArthritisNCT02101307
Multicenter, Post-marketing, Non-interventional, Observational Study in RA Patients Treated With RoActemra/Actemra (Tocilizumab)
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 25 sites in China.
Trial summary
This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 400 participants
- Where
- 25 sitesChina
- Study dates
- 9 Jul 2014to 22 May 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with rheumatoid arthritis starting RoActemra/Actemra treatment
Who may be able to join
- Patients at least 18 years of age
- Patients with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria
- Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label). This can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- Patient has given informed consent
Who cannot join
- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Patients with a history of autoimmune disease or of any joint inflammatory disease other than RA
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
China25 sites
Peking University First Hospital
Beijing, 100034
Peking University Third Hospital
Beijing, 100083
Beijing Union Hospital
Beijing, 100730
Xiangya Hospital of Centre-South University
Changsha, 410008
West China Hospital, Sichuan University
Chengdu, 610041
Sichuan Provincial People's Hospital
Chengdu, 610072
Southwest Hospital , Third Military Medical University
Chongqing, 400038
Sun Yat-sen Memorial Hospital
Guangzhou, 510000
Nanfang Hospital, Southern Medical University
Guangzhou, 510515
The First Affiliated Hospital of Jinan University
Guangzhou, 510630
TCM-Integrated Hospital of Southern Medical University
Guangzhou
Zhejiang People's Hospital
Hangzhou
Affiliated Hospital of Inner Mongolia Medical College
Hohhot
The First People's Hospital of Yunnan Province
Kunming, 650032
The First Affiliated Hospital of Henan UN of Science and Technology
Luoyang, 471003
Affiliated Hospital of North Sichuan Medical College
Nanchong
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, 210029
Futian District people's Hospital of Shenzhen City
Shenzhen
Xinjiang Uygur Autonomous Region People Hospital
Ürümqi, 830001
Tongji Hosp, Tongji Med. Col, Huazhong Univ. of Sci. & Tech
Wuhan, 430030
Wuxi People's Hospital
Wuxi, 214023
The Second Affiliated Hospital of The Fourth Military Medical University (Tangdu Hospital)
Xi'an, 710038
The First Affiliated Hospital of Xiamen University
Xiamen, 361003
YanTaishan Hospital of Yantai City
Yantai
Zhuzhou Central Hospital
Zhuzhou
About this study
Official title: A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning treatment.
- Conditions
- Rheumatoid Arthritis
- 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 |
|---|---|---|
| RA Patients on RoActemra/Actemra treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation
Measured: 6 months
Secondary outcomes (6)
Proportion of patients with systemic manifestation of RA
Measured: At Baseline
Record of RA treatment history
Measured: 6 months
Treatment patterns during observation period, assessed by alteration in dosing regimen
Measured: 6 months
Efficacy as assessed by total joint count evaluation
Measured: 6 months
Incidence of adverse events
Measured: 6 months
Health-related quality of life as assessed by questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2014 (estimated)
- Study start9 Jul 2014
- Primary completion22 May 2017
- Study completion22 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02101307
- Sponsor's protocol ID
- ML28429
- Status last verified
- Dec 2017
- First submitted
- 28 Mar 2014
- Last updated
- 29 Dec 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
- ClinicalTrials.gov ID
- NCT02101307
- Acronym / sponsor ID
- ML28429
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2014 (actual)
- Primary completion
- 22 May 2017 (actual)
- Study completion
- 22 May 2017 (actual)
- First posted
- 2 Apr 2014 (estimated)
- 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.
This non-interventional study will observe the usage and efficacy of RoActemra/Actemra in patients with rheumatoid arthritis (RA) who have recently begun treatment. The treatment regimen will be directed by the treating physician according to clinical practice. Patients are expected to be observed for approximately 6 months after beginning treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA Patients on RoActemra/Actemra treatment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with rheumatoid arthritis starting RoActemra/Actemra treatment
Key inclusion criteria (4 listed)
- Patients at least 18 years of age
- Patients with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria
- Patient in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label). This can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
- Patient has given informed consent
Key exclusion criteria (4 listed)
- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
- Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
- Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- Patients with a history of autoimmune disease or of any joint inflammatory disease other than RA
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
Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation
Time frame: 6 months
6 secondary outcomes
Proportion of patients with systemic manifestation of RA
Time frame: At Baseline
Record of RA treatment history
Time frame: 6 months
Treatment patterns during observation period, assessed by alteration in dosing regimen
Time frame: 6 months
Efficacy as assessed by total joint count evaluation
Time frame: 6 months
Incidence of adverse events
Time frame: 6 months
Health-related quality of life as assessed by questionnaire
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
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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.
Clinical Trials study director
Hoffmann-La Roche
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 25 sites 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 4 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: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients on RoActemra/Actemra treatment 6 months after treatment initiation (time frame: 6 months). 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 29 Dec 2017; AzTrials last refreshed its copy on 3 Nov 2026.