NCT07484243Recruiting
Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis
Source: ClinicalTrials.gov · Last updated 21 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 10000 (estimated)
- First submitted
- 16 Mar 2026
- Start date
- 22 Aug 2025
- Primary completion date
- 30 Sept 2028
- Lead sponsor
- Dongyi He
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT07484243
What you commit to
- Study type: Observational
- Planned participants: 10000
- From 22 Aug 2025 to the primary completion date, 30 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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;
Other illness
- 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;
- Active infections that the investigator deems may interfere with study assessment;
Lab values
- Any clinically or laboratory abnormalities deemed significant by the investigator or other reasons that disqualify participants from this clinical study.
Who the study is looking for
- 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;
- 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);
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Guanghua Hospital of Integrative Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.