Interstitial lung disease associated with rheumatoid arthritis
Conditions
Interventions
Control group:Basic treatment
Definition of basic treatment: The basic treatment adopts the "1+2+3+4" medication regimen
1. In accordance with the guidelines for the diagnosis and treatment of rheumat
2. Glucocorticoids: a. For the patients arthritis symptoms, oral prednisone up to 10mg/day (or equivalent dose) is allowed, but it must be reduced within 3 months
b. If the patients lung HRCT suggests obvious inflammatory exudation (as determined by MDT consultation), oral prednisone (or equivalent) 0.5mg/kg/d can be given and decreased by 5mg every 4 weeks sta
3. Use symptomatic drugs such as NSAIDs, cough and phlegm as needed
4. If the patient has been on stable use of "cyclophosphamide, azathioprine, mycophenolate mycophenolate or rituximab other immunosuppressive drugs outside the study protocol" for 3 months before >=en
Observation group:Basic treatment + Tetrandrine tablets 80mg, taken orally, 3 times a day, for a total of 24 weeks.
Sponsors
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. The patient voluntarily participated in the clinical trial and signed the informed consent form; 2. Age 18-80 years old (inclusive), gender is not limited; 3. Meet the diagnostic criteria for rheumatoid arthritis (RA) (1987 American College of Rheumatology Classification Criteria, or, 2010 ACR/EULAR Classification Criteria) (Annex 1); 4. Meet the diagnostic criteria for interstitial lung disease (ILD) (ILD diagnosis in the 2022 Diagnosis and Treatment Specification for Connective Tissue Disease-related Interstitial Lung Diseases) (Annex 1); 5. The diagnosis of RA and ILD excludes other possibilities, such as pneumoconiosis, allergic alveolitis, idiopathic pulmonary fibrosis, and other connective tissue disease-related interstitial lung disease (CTD-ILD), etc.; 6. Patients have fibrosis abnormalities affecting >= 10% of the lung parenchyma as required by baseline chest HRCT scan, with or without traction bronchiectasis or honeycomb changes; 7. Lung function indicators: FVC% predicted value >=40%, DLCOc SB % predicted value >=30%; 8. The patient has the ability to complete pulmonary function measurements; 9. Patients who meet the above 3-7 inclusion criteria after multidisciplinary consultation (MDT) for interstitial lung disease.
Exclusion criteria
Exclusion criteria: 1. Patients who started or changed corticosteroids or traditional disease-modifying antirheumatic drugs (cDMARDs), biologics (bDMARDs), small molecule drugs, immunosuppressants, and cytotoxic drugs within 1 month before screening due to the treatment of pulmonary manifestations of rheumatoid arthritis, but drug changes based on non-pulmonary manifestations of rheumatoid arthritis are not included in the exclusion criteria; 2. Those who have been treated with Hanfang hexachine tablets or other known anti-fibrotic drugs (pirfenidone, nintedanib) within 1 month before screening; 3. Within half a year before screening or currently participating in other clinical investigators; 4. Patients with other connective tissue diseases or overlap syndromes (including but not limited to scleroderma, Sjogren's syndrome, polymyositis/dermatomyositis, systemic lupus erythematosus, except Raynaud's phenomenon); 5. Have a history of clinically significant environmental exposures known to cause pulmonary fibrosis (PF), including but not limited to dust, asbestos, beryllium, radiation, amiodarone, bleomycin, etc.; 6. Poorly controlled severe asthma and chronic obstructive pulmonary disease, manifested by the need for simultaneous use of "hormones + cholinergic receptor blockers + adrenergic receptor agonists" and adjustment of medication regimen within 3 months before screening; 7. Lower respiratory tract infection diagnosed by the hospital within 14 days or under treatment with anti-infective drugs (but the patient uses anti-infective drugs privately without diagnosis and the number of days of medication is 60 mmHg), severe emphysema, active tuberculosis, acute coronary syndrome within half a year, heart failure requiring hospitalization, etc.; 9. Chest CT shows unilateral pleural effusion > 20% at screening; 10. Patients with lung malignancies at any stage, or patients with non-lung malignancies with an expected survival of = 5×upper limit of normal (ULN), or ALT/AST >= 3 × ULN and total bilirubin (TBIL) >=2× ULN, or alkaline phosphatase (ALP) >=2 × ULN (especially ALP with elevated ?-glutamyl transferase (GGT) and exclusion of bone disease); 13. Patients with severe renal impairment: creatinine clearance < 30 mL/min; 14. Patients with a history of severe organic liver and kidney diseases, such as cirrhosis, active viral hepatitis, Bu-Chiatt syndrome, portal vein thrombosis, tuberculous hepatitis, tuberculous nephritis, hepatic vascular thrombosis, renal artery stenosis, etc., but simple liver cysts, simple kidney cysts, urinary tract stones, gallbladder stones, chronic biliary infections, etc. are not exclusion criteria; 15. Those with clinically significant ECG abnormalities (including QTc interval prolongation), but mild abnormalities that do not require clinical intervention, such as sinus arrhythmia and first-degree atrioventricular block, are not exclusion criteria; 16. Severe anemia (hemoglobin< 60g/L); 17. Men and women, pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced vital capacity percentage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Forced vital capacity;Corrected Single-Breath Diffusing Capacity of the Lung for Carbon Monoxide as a Percentage of Predicted Value;Health Condition;Cough ;Cough Visual Analogue Scale score;Dyspnea Visual Analogue Scale score;Modified British Medical Research Council Dyspnea Scale score;All-cause hospital admissions;Respiratory-related hospital admissions;The slope of the change curve of FVC, FVC% predicted, and DLCOc SB% during the 24-week observation period; | — |
Countries
China
Contacts
Public ContactQinghua Zou
The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Outcome results
None listed