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Active, not recruitingNCT06233929Updated Aug 17, 2025

Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)

An observational study in Rheumatoid Arthritis, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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 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:

  1. 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.
  2. 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.
  3. Develop the related multi-modal prediction models with clinical, biomedical and imaging variables to improve the diagnosis and prognosis of RA.
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Conditions studied

  • Rheumatoid Arthritis
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In context

Arthritis, Rheumatoid

2,888 studies on the registry are indexed under Arthritis, Rheumatoid; 390 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 176 across 824 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification criteria

Exclusion criteria

Exclusion Criteria:

  • Patients do not plan to receive long-term healthcare at SYSMH, PYCH or SS-SYSMH
  • Patients unable to provide written informed consent
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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 .

    Time frame: 60 months

  2. 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.

    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

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Study locations

1 site
  • Department of Rheumatology, Sun Yat-sen Memorial Hospital (SYSMH) of Sun Yat-sen University
    Guangzhou, Guangdong, China
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06233929
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Responsible party
Sponsor
First posted
Jan 31, 2024
Start date
Jan 1, 2024
Primary completion
Dec 31, 2033 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Aug 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.

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