Mass Spectrometry-based Immune Profiling in Autoimmune Diseases

Korábbi kezelés

• Suffering from serious infection (including but not limited to hepatitis, pneumonia, bacteremia, pyelonephritis, EB virus, tuberculosis infection), or being hospitalized due to infection, or using intravenous antibiotics to treat infection 2 months before the first dose of treatment.
• Chest imaging showed abnormalities of malignant tumor or current active infection (including tuberculosis) within 3 months before enrollment.

Más betegség

• Other serious, progressive or uncontrollable hematological, gastrointestinal, endocrine, lung, heart, nerve or brain diseases (including demyelinating diseases, such as multiple sclerosis).
• Any known malignant tumor or history of malignant tumor in the past 5 years. 9. Received any vaccination within 3 months before joining the group.

Laborértékek

• Use IVIg or cyclophosphamide within 1.2 months, use other biological agents (infliximab, adalimumab, etanercept, anakinra, etc.) within 3 months, and use rituximab within 6 months; 2.1 months after receiving high-dose glucocorticoid (> 1 mg/kg/d). 3. Serious complications: including heart failure (≥ NYHA III), renal insufficiency (creatinine clearance rate ≤30 ml/min) and hepatic insufficiency (serum ALT or AST is greater than three times the normal upper limit, or total bilirubin is greater than the normal upper limit).
• Infected with HIV(HIV antibody positive serology) or hepatitis C (Hep C antibody positive serology). If the serum is positive, it is recommended to consult a doctor with expertise in treating HIV or hepatitis C virus infection.

• Male or female, and aged 18-70 at the time of screening interview (inclusive).
• The diagnosis of each disease meets the following standards - Systemic lupus erythematosus: 1997 ACR lupus classification standard
  • Behcet's disease: 2014 ICBD Behcet's disease classification standard
  • ANCA-associated vasculitis: 1990 American College of Rheumatology Classification Standard
  • Rheumatoid arthritis: 1987 ARA classification standard
  • Ankylosing spondylitis: new york standard revised in 1984
  • Sjogren's syndrome: 2016 ACR/EULAR Sjogren's syndrome classification standard
  • Inflammatory myopathy: Bohan recommended criteria in 1977
  • Systemic sclerosis: SSc standard formulated by American Rheumatology Association in 1980.
  • Psoriatic arthritis: CASPAR standard in 2006
  • Gouty arthritis: 1997 ACR gout classification standard
• Disease activity status, each disease should meet the disease activity index;
• Glucocorticoid (≤1mg/kg/d prednisone or other hormones with equivalent dose) was used before joining the group, and DMARDs (such as methotrexate, hydroxychloroquine, azathioprine, mycophenolate mofetil, leflunomide, cyclosporine, etc.) were allowed;
• When participating in the trial, the patient must be informed in writing and hope that the patient can abide by the requirements of the research follow-up plan and other protocols.