Rheumatoid Arthritis-Associated Interstitial Lung Disease (RA-ILD)
Conditions
Interventions
Control Group:Maintain original treatment
Traditional Chinese Medicine Treatment Group:Add Quyu Qingfei Formula to original treatment
Sponsors
Huashan Hospital Affiliated with Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Aged 18-75 years old, with independent capacity, regardless of gender; (2) Comply with the 1987 ACR RA classification standard and/or the 2010 ACR/EULAR RA classification standard; (3) RA remission or low disease activity, DAS28-ESR=3.2; (4) HRCT within 12 months showed the presence of interstitial pneumonia and no improvement in lung function or clinically significant improvement in ILD for 3 months = on stable treatment: i.e., no improvement in absolute FVC % of predicted value within 12 months to Visit 1 (inclusive>). 5% or based on clinician assessment (including symptoms, imaging tests/HRCT, or other assessments deemed relevant and documented by the investigator) considered ILD to require further intervention; (5) Pulmonary function test within 3 months (including the screening period) showed that FVC = 45% of the normal predicted value, DLCO = 30% of the normal predicted value corrected by hemoglobin (Hb); (6) RA-ILD in line with liver and kidney yin deficiency syndrome: Description: Refer to the relevant content of paralysis and asthma in the "Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine (Trial)" and "Diagnostic Efficacy Standards for Internal Diseases of Traditional Chinese Medicine", the main symptoms: chronic joint swelling and deformity, unfavorable flexion and extension, morning stiffness, wheezing and holding breath, chest tightness and shortness of breath, cough and sputum. Secondary symptoms: sore waist and knees, dizziness, irritability, dry throat, hot flashes, night sweats. Tongue pulse: The tongue is red, the moss is small, and the pulse is deep and thin. It has 2 main symptoms and 2 secondary symptoms: or 1 main symptom and 3 secondary symptoms, which can be diagnosed by combining the tongue pulse; (7) Nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesic treatment, which must be treated at a stable dose for at least 2 weeks before enrollment; (8) If oral corticosteroids are administered, the dose must be stable to a dose equivalent to = 10 mg prednisone/day for at least 4 weeks prior to the first dose of study drug prior to enrollment. If glucocorticoids are not used, oral corticosteroids should not be taken at least 2 weeks before inclusion; (9) Meet the following tuberculosis screening criteria: 1) No history of active tuberculosis: 2) No recent close contact history with active tuberculosis patients: 3) No symptoms or signs of active tuberculosis found in medical history and physical examination: 4) Chest CT taken within 3 months before enrollment, confirming no evidence of active tuberculosis; 5) Negative interferon ? tuberculosis release test within 6 weeks before enrollment; (10) Meet the following laboratory test standards: blood routine: neutrophil count (NEUT) = 1.0*10^9/L; Lymphocyte count (LYMPH) =0.5*10^9/L; Hemoglobin (HGB) >80g/L; Platelet count (PLT) > 80*10^9/L. Liver: Aspartate transferase (AST), alanine transferase (ALT), total bilirubin (TBIL) not higher than 1.5 times the upper limit of normal. Renal: eGFR>60ml/min; (11) Patients gave informed consent and agreed to participate in this study.
Exclusion criteria
Exclusion criteria: (1) Secondary to other connective tissue diseases; (2) Combined with other lung diseases, such as lung infections, asthma, tuberculosis, chronic obstructive pulmonary disease, bronchiectasis, and lung tumors; (3) Interstitial lung disease caused by pneumoconiosis, inhalation of organic substances, or drugs; (4) Severe organ damage (heart, brain, liver, kidney, lung, etc.), known malignant tumors, or a history of malignant tumors within the past 5 years, venous thromboembolism, significant or poorly controlled dyslipidemia, or severe infection; patients with psychiatric disorders; (5) Active infection within 3 months prior to the first study drug administration, including shingles, mycobacterial infection, opportunistic infections, etc.; (6) Acute exacerbation of ILD within 3 months prior to the first study drug administration or during screening; (7) Use of or planned use of vaccination within 3 months prior to the first study drug administration, during the study, or within 6 months after the last study drug administration; (8) Positive for hepatitis B DNA, hepatitis C RNA, or HIV antibodies; (9) Allergic to study drugs or contraindicated for use; pregnant or breastfeeding women; male patients with fertility requirements; (10) Any situation in which the investigator considers the subject's participation in the study to carry unacceptable risks. If your doctor determines that you meet the requirements to participate in this study and you voluntarily choose to participate, you will have a total of 6 visits, which will be at the screening prior to treatment, and at weeks 0, 4, 12, 24, 36, and 48. During each visit, the doctor will need to evaluate your efficacy and safety indicators as required by the study, as well as your personal quality of life indicators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Forced Vital Capacity (FVC) mean absolute change; | — |
Secondary
| Measure | Time frame |
|---|---|
| DLCO % predicted;Time of first ILD exacerbation, number of hospitalizations due to ILD, time of death;Absolute change in QILD score [%] from baseline;Quantitative Lung Fibrosis (QLF) score;Quantitative Ground-Glass Opacity (QGGO) score;Living with Pulmonary Fibrosis (L-PF) score; | — |
Countries
China
Contacts
Public ContactWan Weiguo
Huashan Hospital Affiliated with Fudan University
Outcome results
None listed