Rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient meets the 2010 ACR/EULAR classification criteria for RA; 2. Male or female aged 18 years or older, younger than 75 years; disease duration not exceeding 2 years. 3. If using non-steroidal anti-inflammatory drugs (NSAIDs) or other analgesics, the patient must have been on a stable dose for at least 2 weeks before enrollment; if not using corticosteroids, the patient must not have taken oral corticosteroids for at least 2 weeks prior to enrollment. 4. The patient has active disease and at least one poor prognostic factor, as follows: swollen joint count (SJC) >=6, tender joint count (TJC) >=6; ESR >=28 mm/h; CRP >=20 mg/L; serum anti-CCP antibody >10^2 IU/ml; imaging shows >=1 bone erosion, diffuse joint space narrowing, or bone marrow edema. 5. Understand the observational procedures and content, and voluntarily sign the informed consent form to agree to cooperate and participate in the trial.
Exclusion criteria
Exclusion criteria: 1. Known active infections that are currently uncontrolled, such as tuberculosis infection, viral hepatitis, etc.; 2. Patients with severe, progressive, uncontrolled major organ and system diseases (such as class III heart failure, severe liver or kidney dysfunction), or other conditions deemed by the attending physician as unsuitable for participation in this study; 3. Patients who have previously received RA-related targeted therapy after diagnosis; 4. Patients who received intra-articular, intramuscular, or intravenous glucocorticoid treatment within 4 weeks prior to the first study drug administration; those whose oral glucocorticoid dose was not stabilized for at least 4 weeks, and whose dose was not stabilized to <=10 mg prednisone/day before the first study drug administration; 5. Female patients who are pregnant or breastfeeding, become pregnant, are breastfeeding, plan to become pregnant, or have fertility requirements during the study or within 3 months after the study; 6. Patients assessed by a physician to have latent tuberculosis infection or risk of hepatitis B virus reactivation and who cannot receive prophylactic antiviral therapy; 7. Patients with psychiatric disorders or intellectual disabilities.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients in both groups achieving ACR50 remission at 24 weeks; | — |
Countries
China
Contacts
Beijing Friendship Hospital ,Capital Medical University