Rheumatoid Arthritis
Conditions
Interventions
Experimental group1:Single intravenous infusion 20mg
Experimental group2:Single intravenous infusion 40mg
Experimental group3:Single intravenous infusion 60mg
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years (including boundary value), no gender limit; 2. According to ACR1987 or ACR/EULAR 2010 classification criteria, the diagnosis was RA and the medical history was >=6 months; 3. Moderate disease activity: DAS28>3.2 and =3; 5. The curative effect of methotrexate or leflunomide is not good, and the treatment has been stable for >=3 months before screening; 6. BMI>=18.5 and <=30kg/m2; 7. Sign the informed consent form voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with RA whose joint function reaches Grade iv; 2. Complicated with high fever, acute and chronic infection (including active tuberculosis) or sepsis not related to the progression of RA disease; 3. Have used bDMARDs within 3 months before randomization (including but not limited to TNF inhibitors, IL-6 inhibitors, IL-1 inhibitors, IL-17 inhibitors, costimulatory factor modulators, RANKL inhibitors, etc.) Or tsDMARDs (including but not limited to JAK inhibitors, etc.); 4. Have used anti-CD20 monoclonal antibody within 6 months before randomization; 5. Take other csDMARDs or botanical drugs such as Pavlin and Tripterygium wilfordii within 28 days before randomization; 6. Those who have used intra-articular, intramuscular or intravenous corticosteroids within 6 weeks before randomization; 7. Oral corticosteroids (>10 mg/d prednisone equivalent dose) within 6 weeks before randomization; 8. People with autoimmune diseases other than RA, including but not limited to psoriatic arthritis (PsA), ankylosing spondylitis (AS), systemic lupus erythematosus (SLE) or Lyme disease; 9. Immediate relatives or those who have hereditary immunodeficiency disease; 10. People with a history of hematological diseases (including hemolytic anemia) and any lymphoproliferative diseases, such as EBV-related lymphoproliferative diseases, lymphoma, leukemia, myeloproliferative diseases, multiple myeloma, or a history of Current signs and symptoms of lymphatic disease; 11. Glucose-6-phosphate dehydrogenase deficiency; 12. Those who suffer from malignant tumors or have a history of malignant tumors; 13. Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), HIV antibody (Anti-HIV), Treponema pallidum antibody (TP-Ab) test positive; hepatitis B core antibody (anti- HBc) positive and check HBV-DNA positive; 14. Inoculate any vaccine within 3 months before randomization; 15. There is a history of uncontrolled cardiovascular, respiratory, digestive, endocrine, blood, nervous or psychiatric disorders or any other serious and/or unstable diseases or medical conditions as judged by the investigator, and the study The author believes that these diseases or medical history will bring risks when taking study drugs, or will interfere with the interpretation of data; 16. AST or ALT>2 times ULN, total bilirubin >=1.5 times ULN, hemoglobin Upper limit of normal value, triglyceride>10mmol/L; 17. Those who have a history of alcohol or drug abuse; 18. Pregnant or lactating women and those who have a childbirth plan within 3 months after the end of the study; 19. Those who are allergic to the known ingredients of the drug or have a history of severe allergies in the past; 20. The Chinese herbal medicine treatment method being used cannot be stopped during the study period; 21. Those who have participated in any other clinical trials within 3 months before screening; 22. Other situations that the researcher thinks are not suitable for participating in this research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety indicator;Pharmacokinetic index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect index;Exploratory index;Immunogenicity index; | — |
Countries
China
Contacts
Public ContactLi Ru
Peking University People's Hospital
Outcome results
None listed