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

NCT07484243 | Recruiting

• 1 other identifier: 2024-K-115
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA); Rheumatoid Arthritis-Associated Interstitial Lung Disease; Difficult-to-Treat Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• DAS28-ESR at each time point

  The European League Against Rheumatism (EULAR) proposed the mean disease activity score (DAS28) of 28 joints as the efficacy evaluation index for rheumatoid arthritis (RA) disease activity: DAS28 = 0.56\*SQRT(T28) + 0.28\*SQRT(SW28) + 0.70\*Ln(ESR) + 0.014\*VAS

  Efficacy was assessed at weeks 0, 12,24,36, and 52.

Interventions

Integrated Traditional Chinese and Western Medicine DRUG

Integrated Traditional Chinese and Western Medicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Rheumatoid arthritis patients from outpatient or inpatient departments of the participating hospital centers in this study.

You may qualify if:

• Meet the RA classification criteria established by ACR in 1987 or the revised RA diagnostic criteria by ACR/EULAR in 2010;
• D2T-RA must comply with the D2T-RA diagnostic criteria by ACR/EULAR in 2020 or the China D2T-RA diagnostic criteria in 2021;
• 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;
• Receive traditional Chinese medicine treatment;
• Age ≥18 years;
• Sign an informed consent form.

You may not qualify if:

• 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;
• Known clinically significant environmental exposures that may cause pulmonary fibrosis (PF), including but not limited to dust, asbestos, beryllium, radiation, amiodarone, bleomycin, etc.;
• Poorly controlled severe asthma or chronic obstructive pulmonary disease (COPD) with medication adjustments within 3 months prior to screening;
• Active infections that the investigator deems may interfere with study assessment;
• Any clinically or laboratory abnormalities deemed significant by the investigator or other reasons that disqualify participants from this clinical study.

Sponsors & Collaborators

• Yuanyuan Zhang: lead

Study Sites (1)

Shanghai Guanghua Hospital of Integrative Medicine

Shanghai, 200052, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Dongyi He

CONTACT

15800300800; ghyykyk@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: attending physician

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: March 20, 2026
• Study Start: August 22, 2025
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): March 31, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CN (1)