Rheumatoid arthritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Aged 18 years and above, regardless of gender; (2) Clinically diagnosed with rheumatoid arthritis; (3) Agree to participate in this study, be able to cooperate with the follow-up, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients during pregnancy or lactation, or those with a pregnancy plan within 6 months from the period of methotrexate use till its discontinuation; (2) Those with a history of chronic or recurrent infection (such as tuberculosis, chronic viral hepatitis, etc.) or with severe infection; (3) Those complicated with severe, progressive or uncontrolled diseases of the kidneys, liver, blood, gastrointestinal tract, immune system, endocrine system, cardiopulmonary system, mental or nervous system; (4) Those with recurrent or persistent oral ulcers; (5) Those with a history of malignant tumor within the past 5 years; (6) Those with the following abnormal laboratory results: hemoglobin 2× the upper limit of the normal (ULN), alanine aminotransferase (ALT) > 2×ULN, total bilirubin > 5mg/dL (85.5µmol/L), serum creatinine > 1.5 × ULN; (7) Those who participated in other clinical studies within 3 months before enrollment; (8) Those allergic to the relevant drugs used in this study; (9) Those with a history of drug abuse, mental illness or alcoholism and unable to cooperate with the clinical study; (10) Patients who need to use two or more b/tsDMARDs simultaneously during the study period; (11) Other situations deemed by the researcher as inappropriate for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DAS28-ESR; | — |
Secondary
| Measure | Time frame |
|---|---|
| patient's global assessment of disease activity, PGA;Clinical disease activity index, CDAI;EGA;VAS; | — |
Countries
China
Contacts
South China Hospital Affiliated to Shenzhen University