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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06233929
• Other study ID #: SYSKY-2023-1235-01
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: March 1, 2033

Study information

• Verified date: January 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

An ongoing long-term cohort study is conducted in the Sun Yat-sen Memorial Hospital of Sun Yat-sen University, that is dedicated to recruiting RA patients, to identify the development of clinical, neuroimaging, and biochemical biomarkers for the diagnosis and prognosis of RA, especially for those with sarcopenia/myopenia

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, especially the difference between early and lately RA, 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 markers (clinical, biomedical and imaging) affecting/predicting the development process of sarcopenia/myopenia or other prognosis in RA patients.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: March 1, 2033
• Est. primary completion date: March 1, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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 diagnosis with tumors without control, or AIDS

• Patients with serious disease in cardiovascular, kidney and blood and endocrine system; and 3) history of schizophrenia or epilepsy

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Myopenia	Myopenia was defined by an ASMI= 7.0 kg/m2 in men and= 5.7 kg/m2 in women according to the Asian Working Group for Sarcopenia (AWGS)	10 years
Primary	CVDs	CVDs were defined as a verified medical history of angina pectoris, myocardial infarction, heart failure, ischemic or hemorrhagic stroke, and peripheral arterial disease [17], which was verified through a questionnaire survey and confirmation by medical record	10 years