Rheumatoid arthritis
Conditions
Interventions
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects must meet the following criteria to be enrolled in this study: 1. Male or female aged 18-65 (including 18 or 65); 2. RA classification standards revised by American college of rheumatology in 2010; 3. ACR joint function level I, II or III; 4. At least 12 weeks before enrollment, conventional synthetic DMARDs failed to achieve clinical remission or low disease activity, and had not received biological agents treatment; 5. If subjects are treated with NSAIDs or other analgesics, they must be treated with a stable dose of at least 2 Weeks; 6. If oral glucocorticoids are administered, the dose must be stabilized to the equivalent for at least 4 weeks prior to enrollment before the study drug is first administered dose = 85g/L; 2) WBC leukocyte >= 3.5×10^9/L; 3) platelet >= 100×10^9/L; 4) serum aminotransferase and aminotransferase of glutamates were not more than 1.5 times the upper limit of normal value; 5) serum creatinine should not exceed 1.5mg/dL(133umol/L). 10. Agree to sign the informed consent, which must be signed before enrollment; 11. Agree to stop adjuvant therapy such as traditional Chinese medicine and acupuncture 2 weeks before enrollment and throughout the study period.
Exclusion criteria
Exclusion criteria: Subjects meeting the following criteria will not be included in this study: 1. Having inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis and systemic lupus erythematosus; 2. Received intra-articular injection, intramuscular injection or intravenous glucocorticoid within 4 weeks before the first study; 3. Known allergy to isepp, methotrexate or Chinese medicine; 4. Prior to enrollment, biotherapy was used, including (but not limited to) isepurium, zack, ambanol, infliximab, enazepurium, and adamumab, perceizumab, toluximab and rituximab were treated. 5. Subjects who became pregnant, breast-fed, or planned to become pregnant or fathered during or after the study, or women or men with fertility requirements; 6. Active infection (including mycobacterium infection, opportunistic infection, etc.) 3 months before the first study; 7. Within 3 months before the first study, during the study, or within 6 months after the last study; 8. Positive for hepatitis b surface antigen, hepatitis c antibody or human immunodeficiency virus antibody; 9. Have symptoms or signs of severe, progressive or uncontrolled kidneys, liver, blood, gastrointestinal, endocrine, lungs, heart, nerves, mind or brain disease; 10. Complications or a history of heart failure, including asymptomatic heart failure; 11. Lymphoproliferative diseases, including lymphoma, or possible signs of lymphoproliferative diseases; 12. Have a known malignancy or a history of malignancy within the previous 5 years; 13. Organ transplantation; 14. Is participating in experimental studies of other drugs; 15. Other researchers considered it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| low disease activity;DAS28;ACR20;ACR50;adverse effects;Clinical laboratory examination; | — |
Countries
China
Contacts
Public ContactJiang Quan
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed