Rheumatoid Arthritis
Conditions
Interventions
Intervention group:Berberine hydrochloride + methotrexate
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.18-65 years old (including 18 and 65 years old) male or female (no childbearing requirements); 2. Meet the 2010 ACR/EULAR classification standard and the course of disease is less than 1 year, or meet the early 2014 RA classification standard of Peking University People's Hospital and the course of disease is less than 1 year; 3.ACR joint function level I, II or III; 4. Have not received immunosuppressive agents, biologics, small molecule targeted synthetic drugs and other related drug treatment; 5. Patients who had received oral glucocorticoid hormone therapy before enrollment should also be excluded. 6. Oral antibiotics were not allowed two weeks before enrollment; 7. Female and male subjects of reproductive age must use appropriate contraceptive methods during the study period and for 6 months after the last study dose. Female subjects of childbearing age must have a negative pregnancy test; 8. Meet the following TB screening criteria: 1) No history of active TB; 2) no recent history of close contact with active TB patients; 3) No signs or symptoms of active TB are found in the history and physical examination; 4) Chest radiographs (anterior and lateral) taken within 3 months before enrollment confirmed no evidence of active pulmonary tuberculosis; 5) Within the first 6 weeks of enrollment, tuberculosis interferon gamma release test negative or tuberculin test no more than ++. If the interferon gamma release test was positive but active tuberculosis could be ruled out, prophylaxis against tuberculosis (isoniazid + rifampicin) was continued for 6 months before starting treatment; 9. Laboratory inspection standards: 1) Hemoglobin =85g/L; 2)WBC white blood cells =3.5×109/L; 3) Platelet =100×109/L; 4) Serum alanine aminotransferase and aspartate aminotransferase should not exceed 1.5 times the upper limit of normal value; 5) Serum creatinine should not exceed 1.5mg/dL. 10. Agree to sign informed consent, and the informed consent must be signed before joining the group; 11. 2 weeks before enrollment and the whole treatment period (0-12 weeks), they agreed to stop receiving adjuvant therapy such as traditional Chinese medicine and acupuncture.
Exclusion criteria
Exclusion criteria: 1. have other immune or inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, etc.; 2. Received intra-articular, intramuscular, or intravenous glucocorticoid therapy within 4 weeks before the initial study; 3. Used biologic agents including (but not limited to) Escepil, Cianco, Amberol, infliximab, Etanercept, adalimumab, pecezumab, tolumab, rituximab before randomization; 4. Female subjects who plan to become pregnant, breastfeed, or plan to become pregnant during the study period or within 6 months of the end of the study, or male subjects who are fathers, 5. Patients with unstable vital signs, need vasoactive drugs, or need intensive care unit (ICU) support; 6. Patients with intestinal obstruction, severe gastrointestinal bleeding, and septic shock; 7. Active infection, including mycobacterial infection, opportunistic infection, etc., 3 months before the first study; 8. Use or expect to use the vaccine within 3 months before the first study administration, during the study, or 6 months after the last study administration; 9. Positive for hepatitis B surface antigen, positive for hepatitis C antibody or positive for human immunodeficiency virus antibody; 10. Have signs or symptoms of severe, progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric or brain disease; 11. Concurrent heart failure or history of heart failure, including asymptomatic heart failure; 12. Lymphoproliferative diseases, including lymphomas, or signs indicating possible lymphoproliferative diseases; 13. Have a known malignant tumor or a history of malignant tumor within the past 5 years; 14. Perform organ transplant operations; 15. Had received antibiotics in the first two weeks of enrollment, or had to continue to receive antibiotics during treatment because of other co-existing diseases; 16. Participating in other drug trials and studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate of ACR20 at 12 weeks; | — |
Secondary
| Measure | Time frame |
|---|---|
| Response rate of ACR50/70 at 12 weeks;DAS28-CRP at 12 weeks;HAQ-DI at 12 weeks; | — |
Countries
China
Contacts
Public ContactYin Su
Peking University People's Hospital
Outcome results
None listed