Rheumatoid arthritis
Conditions
Interventions
Tocilizumab + Tripterygium glycosides:1.Tocilizumab: 8mg/kg by intravenous drip, every 4 weeks. Dilute to 100ml with 0.9%NS and drip for 1 hour.
2. Tripterygium glycosides: 20mg (2 tablets) orally, th
Tocilizumab:Tocilizumab: 8mg/kg by intravenous drip, every 4 weeks. Dilute to 100ml with 0.9%NS and drip for 1 hour.
Sponsors
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) Age: 18-75 years old, gender not limited; (2) Conform to the 2010 ACR/EULAR RA classification criteria, with a disease course of =6 months; (3) Pulmonary fibrosis confirmed by HRCT (predicted FVC% 40-80%, predicted DLCO% 30-79%); (4) DAS28-ESR >=3.2; (5) Having failed or been intolerant to at least one DMARDs treatment in the past; (6) The patient was clearly diagnosed with RA combined with ILD, and ILD caused by systemic sclerosis (scleroderma), dermatomyositis, systemic lupus erythematosus, Sjogren's syndrome, etc. was excluded. (7) A woman of childbearing age has a negative pregnancy test and agrees to contraception; (8) Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Pulmonary fibrosis caused by other reasons (such as occupational exposure, connective tissue diseases, etc.); (2) Acute pulmonary infection or respiratory tract infection requiring antibiotic treatment; (3) Severe respiratory failure (SpO23 times U/L; (5) Renal insufficiency (eGFR<30ml/min/1.73m²); (6) Neutrophils <1.5×10?/L, platelets <100×10?/L; (7) Active tuberculosis or HBV/HCV/HIV infection; (8) History of malignant tumors (excluding cured basal cell carcinoma of the skin); (9) Pregnant or lactating women; (10) Allergic to the components of the investigational drug; (11) Participated in other clinical trials within three months; (12) Patients who have previously received or are currently receiving pulmonary fibrosis-related drug interventions such as nintedanib and pirfenidone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| High-Resolution Computed Tomography; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diffusing Capacity for Carbon Monoxide;American College of Rheumatology 20;Forced Vital Capacity;Functional Assessment of Chronic Illness Therapy-Fatigue;Health Assessment Questionnaire-Disability Index; | — |
Countries
China
Contacts
Public ContactYao Xueming
The Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine
Outcome results
None listed