Rheumatoid Arthritis
Conditions
Interventions
Yisaipu+Methotrexate:Yisaipu: Subcutaneous injection once a week, 50mg per dose per week
treatment duration is 24 weeks.
Methotrexate tablets: 10-15mg, orally once a week
treatment duration is 24 weeks.
It is recommended to take folic acid 5mg orally once a week during the study process.
Yisaipu+Methotrexate+Tripterygium Wilfordii:Yisaipu Subcutaneous injection once a week, 50mg per dose
treatment duration is 24 weeks.
Tripterygium Wilfordii Polyglycoside tablets: 20mg orally three times a day
treatment duration is 24 weeks.
Methotrexate tablets: 10-15mg orally once a week
Sponsors
Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: To be eligible for this study, participants must meet the following criteria: 1. Fully understand the purpose and requirements of this trial, voluntarily participate and sign a written informed consent form, and be able to complete all research procedures as required by the trial; 2. Males aged 50 or older with no reproductive needs or postmenopausal female patients; 3. Patients diagnosed with RA according to the 1987 revised criteria of the American College of Rheumatology (ACR) or the 2010 classification criteria of the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR); 4. Poor response (DAS28-ESR > 3.2) to at least 12 weeks of treatment with disease-modifying antirheumatic drugs (csDMARDs including methotrexate, leflunomide, and Tripterygium wilfordii polyglycoside) prior to enrollment; 5. If the participant is treated with nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics, they must have been on a stable dose for at least 2 weeks prior to enrollment; 6. If on oral glucocorticoids, the dose must have been stable for at least 4 weeks prior to the first administration of the study drug, equivalent to =10mg prednisone/day. If glucocorticoids have not been used, no oral glucocorticoids should have been taken for at least 2 weeks prior to selection; 7. Meet the following tuberculosis screening criteria: 1) No history of active tuberculosis; 2) No recent history of close contact with patients with active tuberculosis; 3) No symptoms or signs of active tuberculosis found in medical history and physical examination; 4) A chest CT within 3 months prior to enrollment, confirming no evidence of active pulmonary tuberculosis; 5) A negative tuberculosis interferon-gamma release assay within 6 weeks prior to enrollment. 8. Meet the following laboratory test criteria: Hematology: Neutrophil count (NEUT#) =1.0×109/L; Lymphocyte count (LYMPH#) =0.5×109/L; Total white blood cell count (WBC) =3.5×109/L; Hemoglobin (HGB) =80.0g/L; Platelet count (PLT) =80×109/L; Hepatic function: Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), and Total bilirubin (TBIL) not higher than the upper limit of normal values, and investigators judge liver function to be normal in combination with medical history and/or other auxiliary examinations. Renal function: Serum creatinine not higher than the upper limit of normal values, and investigators judge kidney function to be normal in combination with medical history and/or other auxiliary examinations.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria are not eligible for inclusion: 1. Have inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus; 2. Have received intra-articular, intramuscular, or intravenous corticosteroid treatment within 4 weeks prior to the first study drug administration; 3. Have known allergies to the components of Etanercept, Methotrexate, or Tripterygium wilfordii polyglycoside; 4. Have used biologic therapy prior to randomization, including (but not limited to) Etanercept, Onercept, Anakinra, Infliximab, Enbrel, Adalimumab, Certolizumab pegol, Tocilizumab, Rituximab; 5. Pregnant, breastfeeding, or planning to become pregnant or become a father during the study period, or female or male subjects with fertility requirements; 6. Have active infections, including mycobacterial infections, opportunistic infections, etc., within 3 months prior to the first study drug administration or currently; 7. Have received or anticipate receiving vaccinations within 3 months prior to the first study drug administration, during the study period, or within 6 months after the last study drug administration; 8. Test positive for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus antibody; 9. Have severe, progressive, or uncontrolled renal, liver, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, psychiatric, or brain diseases; 10. Have known malignant tumors or a history of malignant tumors within the past 5 years; 11. Are participating in other drug trial studies; 12. Investigators deem that there are any clinically or laboratory significantly abnormal findings or for any other reason deemed unsuitable to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR50;ACR20;ACR70;DAS28;ESR;CRP; | — |
Countries
China
Contacts
Public ContactHe dongyi
Department of Rheumatology, Shanghai Guanghua Hospital of Integrative Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Outcome results
None listed