Rheumatoid Arthritis
Conditions
Interventions
Sponsors
Affiliated Hospital of North Sichuan Medical College
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The subjects signed the informed consent form before the trial, and fully understood the content, process and possible adverse reactions of the trial; Voluntary participation and ability to complete the study in accordance with the requirements of the trial protocol; 2. Male and female subjects aged 18~65 years old (including 18 years old and 65 years old); 3. Female subjects (of childbearing age) should have a negative pregnancy test result during the screening period and agree to use effective contraception for the duration of the study. Female subjects who are postmenopausal, have undergone total hysterectomy, bilateral tubal ligation, and/or bilateral salpingectomy, or have congenital infertility are considered of childbearing potential; 4. Those who meet the 2010 American College of Rheumatology and European League Against Rheumatism diagnostic criteria and scoring system for RA; 5. Those with a score of greater than 3.2 points on the Rheumatoid Arthritis Disease Activity Evaluation Form (DAS28) (disease activity is moderate to severe); 6. Those who have not participated in any drug trial within 1 month before induction.
Exclusion criteria
Exclusion criteria: 1. Those with a history of specific allergies (asthma, urticaria, eczema, etc.), or allergies, or allergies to the components of this drug; 2. History of non-tuberculous mycobacterial infection or conditional pathogenic bacterial infection (such as cytomegalovirus, pneumocystisis, pulmonary aspergillosis, etc.) in the 6 months prior to screening; 3. Active tuberculosis or other serious infectious diseases, such as sepsis and opportunistic infections; 4. Have moderate to severe congestive heart failure (New York Heart Association Class III or IV); 5. History of chronic infection requiring treatment (such as chronic bronchitis, chronic pyelonephritis, etc.) within 12 months prior to screening; 6. Those who have one or more positive tests for hepatitis B virus surface antigen, hepatitis C virus antibody, syphilis-specific antibody, and human immunodeficiency virus antibody; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times the upper limit of normal or total bilirubin (T-BIL) > 1.5 times the upper limit of normal; 7. During the screening period, the absolute value of lymphocytes is less than 500cells/mm3 and the percentage of neutrophils is less than 40% (the examination can be repeated once for confirmation if determined by the research doctor); 8. Patients with creatinine clearance < 60 mL/min calculated using the simplified MDRD formula; (creatinine clearance = (140-age) × body weight (kg) / (0.818× creatinine value CREA (µmol/L)), multiplied by 0.85 if it is a woman); 9. Have a history of lymphoproliferative diseases, such as lymphoma; or the presence of signs or symptoms suggestive of a lymphoproliferative disorder, including abnormal lymphadenopathy or hepatosplenomegaly; 10. Have a history of malignancy or malignancy (except for cutaneous non-melanoma that has been treated and has no signs of recurrence, and cervical intraepithelial neoplasia that has been resected); 11. Cardiovascular and cerebrovascular events leading to hospitalization within 12 months prior to randomization, including but not limited to percutaneous coronary endovascular angioplasty, coronary artery bypass grafting, cerebral hemorrhage, and subarachnoid hemorrhage; 12. Have a history of organ transplantation (except for those who have corneal transplantation surgery = 3 months before screening); 13. Major surgery within 3 months prior to randomization, or planned major surgery during the study; 14. Have a severe mental or neurological disorder or disease (including alcoholism), unwilling to communicate or have a language barrier that is unable to fully understand and cooperate; 15. Pregnant women, lactating women, and men or women who have planned to have children in the past 6 months; 16. In the opinion of the investigator, it is not eligible to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who met ACR20 criteria at 24 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean disease activity score for the 28 joints;Proportion of subjects who achieved ACR50, ACR70 criteria after 24 weeks;Based on the RA patient report outcome (PRO) scale;Quantitative assessment of viability;Changes in IL-6 before and after 24 weeks of treatment;Bone metabolic markers before and after 24 weeks of treatment;Radiographic changes of the patient's hands before and after 24 weeks of treatment;Incidence and severity of adverse events; | — |
Countries
China
Contacts
Public ContactLingqin Li
Affiliated Hospital of North Sichuan Medical College
Outcome results
None listed