Integrated Traditional Chinese and Western treatment for rheumatoid arthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Shanghai Guanghua Hospital of Integrative Medicine
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Dongyi He
• Email: ghyykyk@163.com
• Phone: 15800300800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Heart Rate Variability and Rheumatoid Arthritis: What HRV Looks Like with RA

  This study checks whether continuous HRV data from an Oura ring can reflect RA disease activity in adults with RA.

  Recruiting University of Central Florida · Orlando, Florida · NCT07878975

• Discontinuing MTX or LEF in RA Patients on TNF Inhibitors

  This trial tests whether stopping methotrexate or leflunomide while continuing a TNF inhibitor is not worse for disease control in adults with rheumatoid arthritis.

  Recruiting Phase 4 Sint Maartenskliniek · Nijmegen, Gelderland and 3 other locations · NCT07802678

• FT839 therapy for autoimmune diseases

  This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

  Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

• Telitacicept for difficult-to-treat rheumatoid arthritis

  This study tests whether adding telitacicept to standard therapy helps adults with hard-to-treat rheumatoid arthritis see better control of their symptoms.

  Recruiting Phase 2 Peking University People's Hospital · Hefei, Anhui and 46 other locations · NCT07796516

• 24-Hour Movement and Atherosclerotic Risk in adults with rheumatoid arthritis

  This study tests how daily activity, sitting, and sleep relate to heart-related risk in adults with RA, using wearables and follow-up after a year.

  Recruiting São Paulo State University · Presidente Prudente, São Paulo · NCT07774507

• Integrative AI profiling of chronic RA pain

  This study tests whether an AI-driven multiomic and neurophysiological approach can help explain and predict persistent pain in adults with active rheumatoid arthritis.

  Recruiting 4th Military Clinical Hospital with Polyclinic, Poland · Wroclaw · NCT07769619

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.