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

This is a large-scale, multicenter observational study on the treatment of rheumatoid arthritis (RA) with integrated Traditional Chinese and Western medicine. The study plans to enroll at least 10,000 patients, including a minimum of 1,000 cases with difficult-to-treat RA (D2T RA) and 1,000 cases with RA-associated interstitial lung disease (RA-ILD). Through long-term follow-up, data will be collected on Traditional Chinese Medicine (TCM) syndrome characteristics, treatment plans, adverse drug reactions, and complications. Biological samples, including blood and urine, will also be collected. The research will utilize multi-omics technologies such as genomics and proteomics, combined with clinical data, to deeply explore the modern scientific connotation of the "disease-syndrome-symptom" framework in RA. The goal is to clarify the patterns and advantages of TCM syndrome differentiation and treatment. Based on these findings, a scientific and standardized efficacy evaluation system for integrated treatment will be established, and optimized treatment strategies for D2T RA and RA-ILD will be developed. The project is led by multiple national TCM clinical research centers and regional diagnostic and treatment centers, including the First Teaching Hospital of Tianjin University of TCM and Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine. These institutions have mature clinical research platforms, biobanks, and databases, providing a solid foundation for the successful implementation of this study. The results of this research will provide a scientific basis for the integrated treatment of RA, promote the standardization of diagnostic and treatment protocols, and ultimately improve the overall level of RA prevention and treatment in China.

NCT Number	NCT07484243
Lead Sponsor	Dongyi He
Conditions	Rheumatoid Arthritis (RA), Rheumatoid Arthritis-Associated Interstitial Lung Disease, Difficult-to-Treat Rheumatoid Arthritis
Enrollment	10,000 participants
Start Date	2025-08-22
Primary Completion	2028-09-30 (estimated)
Study Completion	2029-03-31 (estimated)
Updated on ClinicalTrials.gov	2026-07-21