A prospective, multicenter, randomized, open study on the efficacy and safety of Yisaipu combined with traditional Chinese medicine for standard treatment and maintenance therapy in RA patients who failed traditional DMARDs treatment

Phase 4

• Conditions: Rheumatoid arthritis

• Registration Number: ITMCTR1900002628
• Lead Sponsor: Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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 <= 10mg prednisone /day. If glucocorticoid is not used, oral glucocorticoid should not be taken at least 2 weeks before enrollment. After into the group allowed to reduce the amount, according to the needs of their own decision. Glucocorticoid can help control the disease. In order to avoid interfering with the disease, it must be stable in the first 2 weeks. After the selection, if the condition is better, can reduce the amount. Since the dose is small (<10mg/d), the reduction scheme can be determined by oneself. However, reduction is not encouraged and it is recommended to maintain the small dose.
7. Female and male subjects of reproductive age must use appropriate contraception during the study period and within 6 months after the last study administration. Childbearing age female subjects must have a negative pregnancy test;
8. Meet the following TB screening criteria:
1) no history of active tuberculosis;
2) no recent close contact with active TB patients;
3) no symptoms or signs of active TB were found in the medical history and physical examination;
4) chest radiographs taken within 3 months before enrollment (positive and lateral) proved no evidence of active tuberculosis;
5) within 6 weeks before enrollment, the tuberculin test should not exceed (++). If tuberculin test positive but can exclude active knot nuclear, start treatment simultaneously prevent anti-tuberculosis treatment (isoniazid + rifampicin) for 6 months;
9. Laboratory inspection standards:
1) hemoglobin >= 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

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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
adverse effects;ACR50;ACR20;Clinical laboratory examination;low disease activity;DAS28;