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

NCT ID: NCT06233929

Last Updated: 2025-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2033-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years or older and diagnosed with RA according to 1987 ACR or 2010 ACR / EULAR classification 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Rheumatology, Sun Yat-sen Memorial Hospital (SYSMH) of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 40659397 (View on PubMed)

Other Identifiers

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SYSKY-2023-1235-01

Identifier Type: -

Identifier Source: org_study_id

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