Long-term tracking of refractory rheumatoid arthritis outcomes

Prospective Cohort Study on Refractory Rheumatoid Arthritis

This project will follow adults with refractory rheumatoid arthritis to see how their disease activity and treatments change over time.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University Third Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07126431 on ClinicalTrials.gov

What this trial studies

This is a prospective observational cohort enrolling adults with rheumatoid arthritis who meet the EULAR definition of difficult-to-treat (refractory) RA and have at least one year of csDMARD therapy. Participants will be recruited at Peking University Third Hospital and followed longitudinally with routine clinical assessments and data collection on treatments, disease activity, and outcomes. No experimental interventions are assigned; investigators will analyze real-world treatment patterns, response trajectories, and potential predictors of persistent disease activity. The goal is to better characterize refractory RA and inform more targeted management strategies.

Who should consider this trial

Good fit: Adults (age >18) with RA meeting the 1987 ACR or 2010 ACR/EULAR criteria, treated with conventional synthetic DMARDs for at least one year and meeting the EULAR difficult-to-treat (refractory) RA definition, who can provide informed consent and attend follow-up at the study site.

Not a fit: People with early RA (less than one year of DMARD therapy), those who do not meet the refractory RA definition, or those unable/unwilling to participate in follow-up are unlikely to benefit from this cohort.

Why it matters

Potential benefit: If successful, the findings could help clinicians identify patients at risk of persistent disease and guide more personalized treatment decisions.

How similar studies have performed: Other observational cohorts have described clinical features and risk factors of refractory RA, but interventional advances specifically targeting refractory phenotypes remain limited.

Eligibility criteria

Inclusion Criteria:

1. Meet the 1987 American College of Rheumatology (ACR) classification criteria for RA or the 2010 ACR/European Alliance of Associations for Rheumatology (EULAR) classification criteria for RA.
2. Age \>18 years.
3. Treatment with conventional synthetic DMARDs (csDMARDs) for at least 1 year.
4. Fulfill the EULAR definition of difficult-to-treat RA (refractory RA).
5. Provide written informed consent.

Exclusion Criteria:

1. Age \<18 years.
2. Duration of DMARD therapy \<1 year.
3. Patients unwilling to participate in the cohort study.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Third Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jinxia Zhao, Doctor

Conditions Rheumatoid Arthritis