Integrated Traditional Chinese and Western treatment for rheumatoid arthritis

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

This project will try combining Traditional Chinese Medicine with Western treatments in people with rheumatoid arthritis, including those with difficult-to-treat disease and lung involvement.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Shanghai)
• Trial ID: NCT07484243 on ClinicalTrials.gov

What this trial studies

This large multicenter observational cohort will enroll at least 10,000 people with RA, including at least 1,000 with difficult-to-treat RA and 1,000 with RA-associated interstitial lung disease. Participants will receive integrated TCM and Western care as part of routine management while researchers collect detailed clinical data, TCM syndrome classifications, treatment plans, adverse events, and long-term outcomes. Blood and urine samples will be banked and analyzed using multi-omics approaches (genomics, proteomics, etc.) to identify biomarkers linking RA phenotypes with TCM syndromes. The project aims to build a multicenter biobank and a standardized efficacy evaluation framework to support personalized integrated treatment strategies.

Who should consider this trial

Good fit: Adults who meet ACR or ACR/EULAR criteria for rheumatoid arthritis—including those meeting criteria for difficult-to-treat RA or confirmed RA-associated interstitial lung disease—who can provide biological samples and commit to long-term follow-up are ideal candidates.

Not a fit: People who do not receive integrated TCM–Western care as part of their treatment, cannot provide samples or attend follow-up visits, or whose interstitial lung disease is due to non-RA causes are unlikely to benefit from the study's findings.

Why it matters

Potential benefit: If successful, this work could enable more personalized, standardized combined TCM–Western treatment plans and better outcome prediction for people with RA, especially those with difficult-to-treat disease or lung involvement.

How similar studies have performed: Smaller single-center and clinical observational reports have suggested benefits of combining TCM with Western therapies, but a large multicenter cohort with multi-omics validation is novel.

Eligibility criteria

Inclusion Criteria:

1. Meet the RA classification criteria established by ACR in 1987 or the revised RA diagnostic criteria by ACR/EULAR in 2010;
2. D2T-RA must comply with the D2T-RA diagnostic criteria by ACR/EULAR in 2020 or the China D2T-RA diagnostic criteria in 2021;
3. RA-ILD patients require joint evaluation by rheumatologists and pulmonologists, with a clear diagnosis of ILD and exclusion of other possibilities such as pneumoconiosis, allergic alveolitis, idiopathic pulmonary fibrosis, and other connective tissue disease-related interstitial lung diseases (CTD-ILD);
4. Traditional Chinese medicine syndrome differentiation standards refer to the "Guidelines for Diagnosis and Treatment of Rheumatoid Arthritis" by the China Association of Chinese Medicine, the "Clinical Research Guidelines for New Traditional Chinese Medicine Drugs" by the National Medical Products Administration, and the "Diagnostic and Therapeutic Criteria for Traditional Chinese Medicine Diseases" by the Institute of Clinical Research of the China Academy of Chinese Medical Sciences;
5. Receive traditional Chinese medicine treatment;
6. Age ≥18 years;
7. Sign an informed consent form.

Exclusion Criteria:

1. Severe, progressive, or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental health, or brain, or current known malignant tumors;
2. Known clinically significant environmental exposures that may cause pulmonary fibrosis (PF), including but not limited to dust, asbestos, beryllium, radiation, amiodarone, bleomycin, etc.;
3. Poorly controlled severe asthma or chronic obstructive pulmonary disease (COPD) with medication adjustments within 3 months prior to screening;
4. Active infections that the investigator deems may interfere with study assessment;
5. Any clinically or laboratory abnormalities deemed significant by the investigator or other reasons that disqualify participants from this clinical study.

Where this trial is running

Shanghai

• Shanghai Guanghua Hospital of Integrative Medicine — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Dongyi He

Conditions Rheumatoid Arthritis; Rheumatoid Arthritis-Associated Interstitial Lung Disease; Difficult-to-Treat Rheumatoid Arthritis