Rheumatoid ArthritisNCT06233929
Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)
An observational study of Rheumatoid Arthritis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
An ongoing long-term prospective cohort study is conducted by our team, that is dedicated to recruit patients with RA, to identify the development of clinical, biomedical, histopathological and imaging biomarkers for the diagnosis and prognosis of difficult-to-treat RA, and RA-related complications / comorbidities… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The patients with RA will be consecutively recruited during 2024 and 2033 from the Department of Rheumatology, Sun Yat-sen Memorial Hospital (SYSMH) of Sun Yat-sen University, The Affiliated Panyu Central Hospital (PYCH) of Guangzhou Medical University in Guangzhou, and ShenShan Medical center, Memorial Hospital of Sun Yat-sen University (SS-SYSMH) in Shanwei, P.R China. The inclusion criteria for this study are as follows: 1) diagnosis with RA according to 1987 ACR [41] or 2010 ACR/EULAR classification criteria [42]; 2) age ≥ 18 years old. The exclusion criteria are as follows: 1) patients do not plan to receive long-term healthcare at SYSMH, PYCH or SS-SYSMH; 2) unable to provide written informed consent.
Who may be able to join
- Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria
Who cannot join
- Patients do not plan to receive long-term healthcare at SYSMH, PYCH or SS-SYSMH
- Patients unable to provide written informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Rheumatology, Sun Yat-sen Memorial Hospital (SYSMH) of Sun Yat-sen University
Guangzhou, Guangdong
About this study
An ongoing long-term prospective cohort study is conducted by our team, that is dedicated to recruit patients with RA, to identify the development of clinical, biomedical, histopathological and imaging biomarkers for the diagnosis and prognosis of difficult-to-treat RA, and RA-related complications / comorbidities including sarcopenia, CVD, malignancies, specific infections (especially tuberculosis, herpes zoster, and HBV reactivation), and to evaluate their impact on the long-term prognosis of RA.
To improve the prognosis of RA, this study includes the following objectives:
- Construct a useful database to explore the secular dynamic progress of RA, including RA progression and complications (e.g., sarcopenia, CVD, malignancies, infections), as well as to improve our understanding of the life-course factors affecting the process that will facilitate future research activities.
- Identify the potential biomarkers (clinical, biochemical, histopathological, and imaging markers) to develop multimodal models predicting outcomes in high-risk RA subgroups like difficult-to-treat RA.
- Develop the related multi-modal prediction models with clinical, biomedical and imaging variables to improve the diagnosis and prognosis of RA.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
RA disease outcomes
The primary clinical end-point is the proportion of patients achieving CDAI remission (CDAI≤2.8). The primary functional end-point is the proportion of patients with functional limitation (HAQ-DI>1) . The primary radiographic end-point is the proportion of patients without radiographic progression defined as no increase in mTSS from baseline to 60 months (ΔmTSS≤0) . Radiographs are scored by two experienced and well-trained readers (a radiologist and a rheumatologist) who are aware of the chronological order of the sets of images but not unaware of all other data .
Measured: 60 months
RA-related complication or comorbidity outcomes
Predefined RA-related complication or comorbidity end-points are muscular, cardiovascular, malignant, specific infectious outcomes and additional adverse events.
Measured: All adverse events are collected from the time the subject signs the informed consent form until the end of the follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2033 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06233929
- Sponsor's protocol ID
- SYSKY-2023-1235-01
- Status last verified
- Jun 2025
- First submitted
- 22 Jan 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lin JZ, Zhu Y, Li QH, Ouyang ZM, Liu HJ, Zou YW, Yang Y, Yang KM, Yang LJ, Yang ZH, Zhang L, Mo YQ, Ma JD, Dai L. Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA): protocol for a multicentre prospective, longitudinal cohort study. BMJ Open. 2025 Jul 13;15(7):e092583. doi: 10.1136/bmjopen-2024-092583.
PubMed 40659397
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)
- ClinicalTrials.gov ID
- NCT06233929
- Acronym / sponsor ID
- SYSKY-2023-1235-01
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2033 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 31 Jan 2024 (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.
An ongoing long-term prospective cohort study is conducted by our team, that is dedicated to recruit patients with RA, to identify the development of clinical, biomedical, histopathological and imaging biomarkers for the diagnosis and prognosis of difficult-to-treat RA, and RA-related complications / comorbidities including sarcopenia, CVD, malignancies, specific infections (especially tuberculosis, herpes zoster, and HBV reactivation), and to evaluate their impact on the long-term prognosis of RA.
To improve the prognosis of RA, this study includes the following objectives:
- Construct a useful database to explore the secular dynamic progress of RA, including RA progression and complications (e.g., sarcopenia, CVD, malignancies, infections), as well as to improve our understanding of the life-course factors affecting the process that will facilitate future research activities.
- Identify the potential biomarkers (clinical, biochemical, histopathological, and imaging markers) to develop multimodal models predicting outcomes in high-risk RA subgroups like difficult-to-treat RA.
- Develop the related multi-modal prediction models with clinical, biomedical and imaging variables to improve the diagnosis and prognosis of RA.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients with RA will be consecutively recruited during 2024 and 2033 from the Department of Rheumatology, Sun Yat-sen Memorial Hospital (SYSMH) of Sun Yat-sen University, The Affiliated Panyu Central Hospital (PYCH) of Guangzhou Medical University in Guangzhou, and ShenShan Medical center, Memorial Hospital of Sun Yat-sen University (SS-SYSMH) in Shanwei, P.R China. The inclusion criteria for this study are as follows: 1) diagnosis with RA according to 1987 ACR [41] or 2010 ACR/EULAR classification criteria [42]; 2) age ≥ 18 years old. The exclusion criteria are as follows: 1) patients do not plan to receive long-term healthcare at SYSMH, PYCH or SS-SYSMH; 2) unable to provide written informed consent.
Key inclusion criteria (1 listed)
- Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria
Key exclusion criteria (2 listed)
- Patients do not plan to receive long-term healthcare at SYSMH, PYCH or SS-SYSMH
- Patients unable to provide written informed consent
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
RA disease outcomes
Time frame: 60 months
The primary clinical end-point is the proportion of patients achieving CDAI remission (CDAI≤2.8). The primary functional end-point is the proportion of patients with functional limitation (HAQ-DI>1) . The primary radiographic end-point is the proportion of patients without radiographic progression defined as no increase in mTSS from baseline to 60 months (ΔmTSS≤0) . Radiographs are scored by two experienced and well-trained readers (a radiologist and a rheumatologist) who are aware of the chronological order of the sets of images but not unaware of all other data .
RA-related complication or comorbidity outcomes
Time frame: All adverse events are collected from the time the subject signs the informed consent form until the end of the follow-up period
Predefined RA-related complication or comorbidity end-points are muscular, cardiovascular, malignant, specific infectious outcomes and additional adverse events.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Derived from this study: PubMed 40659397Lin JZ, Zhu Y, Li QH, Ouyang ZM, Liu HJ, Zou YW, Yang Y, Yang KM, Yang LJ, Yang ZH, Zhang L, Mo YQ, Ma JD, Dai L. Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA): protocol for a multicentre prospective, longitudinal cohort study. BMJ Open. 2025 Jul 13;15(7):e092583. doi: 10.1136/bmjopen-2024-092583.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Rheumatoid Arthritis, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
RA disease outcomes (time frame: 60 months). 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?
On the ClinicalTrials.gov record for NCT06233929, which also lists 1 linked publication.
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 17 Aug 2025.