Rheumatoid arthritis
Conditions
Interventions
Observation group:None
Sponsors
ShangHai GuangHua Hospital of Integrated Traditiona Chinese and Western Medicine
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age 18 years old and above, gender is not limited; 2. Clinical diagnosis of rheumatoid arthritis; 3. Those who have not had a clinical response to previous oral methotrexate with or without any kind of csDMARD (defined as DAS28-ESR>2.6, stable dose maintenance medication >=8 weeks), and are currently ready to switch oral methotrexate to subcutaneous methotrexate therapy after clinician evaluation, and the expected benefits outweigh the risks; 4. 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. Pregnant or lactating patients, or those who have a pregnancy plan during the period of methotrexate medication and within 6 months after discontinuation; 2. Those with a history of chronic or recurrent infections (such as tuberculosis, chronic viral hepatitis, etc.), or severe infections; 3. Concomitant severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, immunologic, endocrine, cardiopulmonary, psychiatric, or neurological diseases; 4. Recurrent or persistent mouth ulcers; 5. History of malignant tumor within 5 years; 6. Those with abnormal following laboratory results: hemoglobin 2× upper limit of normal range (ULN), alanine aminotransferase (ALT) >2×ULN, total bilirubin >5mg/dL (85.5µmol/L), serum creatinine > 1.5 × ULN; 7. Those who have participated in other clinical studies within 3 months before enrollment; 8. Those who are allergic to the relevant drugs used in this study; 9. Those who have a history of drug abuse, mental illness or alcoholism, and cannot cooperate with clinical research; 10. In addition to one csDMARD and oral methotrexate, the subject is on other drugs with therapeutic effects on RA at the same time as glucocorticoids, and the dose of the drug has been adjusted within 1 month before enrollment, or is expected to be adjusted at the time of enrollment; 11. Other conditions that the investigator considers inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint disease activity score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The patient's overall assessment of their condition;Clinical disease activity index;The physician's overall rating of the patient's condition;Pain VAS score; | — |
Countries
China
Contacts
Public ContactDongyi He
ShangHai GuangHua Hospital of Integrated Traditiona Chinese and Western Medicine
Outcome results
None listed