Arthritis Clinical Trials

‣ Subjects must meet all of the following inclusion criteria

• Voluntarily sign the informed consent;

• Male or female aged 18-65 years (inclusive) at the time of signing the informed consent;

• Diagnosis of RA for ≥3 months according to the ACR/EULAR 2010 Rheumatoid Arthritis Classification Criteria at the screening visit;

• At the screening visit, presence of recurrent swelling and pain in at least one knee, with a WOMAC pain score ≥4, synovial inflammation confirmed by joint ultrasound, and no significant improvement following 3 months of anti-RA treatment (including prior use of MTX standard therapy, biologics, or small molecule targeted drugs);

• Subjects must have received csDMARD therapy for ≥3 months, with a stable dose for ≥4 weeks prior to screening;

• Background treatment with stable-dose MTX standard therapy, biologics, or small molecule targeted drugs, either alone or in combination, is permitted;

• The following csDMARDs, either alone or in combination, are permitted as background treatment, provided the dose has been stable for ≥4 weeks prior to screening: oral or IV MTX (10-25 mg/week; for subjects intolerant to doses ≥10 mg/week, the dose should be ≥7.5 mg/week), SAS (≤3 g/day), hydroxychloroquine (≤400 mg/day), and LEF (≤20 mg/day);

• Stable-dose NSAIDs are permitted, provided the dose has remained stable for ≥2 weeks prior to screening;

• All females of childbearing potential must have a negative blood pregnancy test within 7 days prior to treatment initiation and must not be breastfeeding. Females not of childbearing potential may be exempt from the pregnancy test and contraception. All enrolled patients (regardless of gender) must use at least one highly effective method of contraception, including adequate barrier methods, throughout the study duration;

⁃ Subjects must be in good overall health, able to ambulate independently (excluding those requiring a wheelchair, walker, or crutches);

⁃ Willingness and ability to adhere to scheduled visits, treatment regimens, laboratory tests, and other study-related procedures.