Rheumatoid Arthritis Real-world Cohort Study in China (ReALSA)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 2,000
- Locations
- 1
- Primary Endpoint
- RA disease outcomes
Study Overview
Brief 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:
- 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported