Rheumatoid Arthritis
Conditions
Interventions
Experimental group:Yisaipu combined with methotrexate and folic acid
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-65 years (including 18 and 65 years old) , no gender limit; 2. Meet the RA classification criteria of the 2010 ACR/EULAR; 3. DAS28-CRP >= 3.2; 4. Have not achieved clinical remission or low disease activity using traditional synthetic DMARDs at least 12 weeks before enrollment, and have not received biological treatment; 5. If subjects are treated with non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics, they must be treated with stable doses for at least 2 weeks before enrollment; 6. If oral corticosteroids are administered, their dose must be stabilized to a dose equivalent to <=10 mg prednisone/day for at least 4 weeks prior to the first dose of study drug prior to enrollment. If glucocorticoids are not used, oral glucocorticoids should not be administered for at least 2 weeks prior to enrollment; 7. Meet the following TB screening criteria: (1) No history of active tuberculosis; (2) No recent history of close contact with active tuberculosis patients; (3) No symptoms or signs of active tuberculosis were found in the medical history and physical examination; (4) Chest X-ray (frontal and lateral view) taken within 3 months before enrollment, confirming no evidence of active pulmonary tuberculosis; (5) The T-SPOT.TB test was negative within 6 weeks before enrollment. If the tuberculin test is positive but active tuberculosis can be ruled out, start treatment and prevent anti-tuberculosis therapy (isoniazid + rifampicin) for 6 months; 8. Agree to sign the informed consent form, which must be signed before enrollment.
Exclusion criteria
Exclusion criteria: 1. Suffering from inflammatory diseases other than RA, including but not limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus; 2. Received intra-articular injection, intramuscular injection or intravenous injection of glucocorticoid therapy within 4 weeks before the first study drug; 3. Known to be allergic to the ingredients of Yisaipu; 4. Have used biological or small molecule targeted drug therapy before enrollment, including (but not limited to) Yisaipu, Qiangke, Embryo, Infliximab, Etanercept, Adalimumab, Percetizumab, Tocilizumab, Rituximab, Tofacitinib, Baricitinib; 5. The subject has used the following non-biological DMARDs or other RA treatment drugs within 28 days before baseline. However, topical drugs other than RA treatment drugs can be used in combination, such as leflunomide, iguratimod, tacrolimus, cyclosporine, cyclophosphamide, azathioprine, minocycline, and mizoribine; 6. The subject has used the following Chinese herbal medicines or other herbal medicines for the treatment of RA within 28 days before the baseline: Tripterygium wilfordii, total glucosides of paeony, and sinomenine; 7. Subjects who are pregnant, breastfeeding, planning to become pregnant or subjects with reproductive requirements during the study or within 3 months after the end of the study; 8. Currently suffering from active infection; 9. Use or are expected to use live attenuated vaccines within 3 months before the first study drug, during the study, or within 6 months after the last study drug; 10. Hepatitis B surface antigen positive, hepatitis C antibody positive or human immunodeficiency virus antibody positive; 11. Symptoms or signs of severe, progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, pulmonary, cardiac, neurological, mental or brain diseases; 12. Concurrent heart failure or a history of heart failure, including asymptomatic heart failure; 13. Lymphoproliferative diseases, including lymphoma or signs suggesting the possibility of lymphoproliferative diseases; 14. Known malignant tumor or a history of malignant tumor within the past 5 years; 15. Organ transplantation; 16. Participating in other drug trials and researches; 17. Reasons for other researchers who think it is inappropriate to participate in the research; 18. ACR joint function grade IV and above.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ESR;C-reactive protein;cytokines;immune cell subtypes; | — |
Secondary
| Measure | Time frame |
|---|---|
| anti-cyclic citrullinated peptide antibody; | — |
Countries
China
Contacts
Public ContactLi Zhan'guo
Peking University People's Hospital
Outcome results
None listed