A Real-World Study of Subcutaneous Methotrexate (Pre-filled) in Chinese Rheumatoid Arthritis (RA) Patients
Design: A prospective, single-arm, multicenter, real-world study that does not interfere with the patient's treatment plan Primary
Objective: 1\. To evaluate the effectiveness and safety of subcutaneous Methotrexate (MTX) in RA patients in a real-world setting; Exploratory
Objectives: 1. To assess the safety and effectiveness of subcutaneous MTX in RA patients with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs), and stable coronary artery disease (SCAD) in a real-world setting; 2. To evaluate the effectiveness and safety of subcutaneous MTX in RA patients with different clinical subtypes. The study includes adult RA patients treated with subcutaneous MTX, divided into the following four cohorts based on comorbidities and clinical subtypes: Cohort 1: Chinese RA patients receiving subcutaneous MTX treatment (8,000 cases) Cohort 2: Chinese RA patients with ILD or ILAs receiving subcutaneous MTX treatment (200 cases) Cohort 3: Chinese RA patients with clinical subtype results at enrollment, receiving subcutaneous MTX treatment (1,500 cases) Cohort 4: Chinese RA arthritis patients with SCAD receiving subcutaneous MTX treatment (300 cases)
• Adult patients diagnosed with rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR classification criteria.
• Patients who, after clinical evaluation, are starting or preparing to start subcutaneous methotrexate treatment, with expected benefits outweighing the risks.
• Patients who agree to participate in the study, can comply with follow-up, and sign the informed consent form.
⁃ Additionally, subjects meeting the following inclusion criteria can be assigned to Cohort 2:
• Diagnosed with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs) prior to or at the time of enrollment;
• Have baseline forced vital capacity (FVC) results at the time of enrollment, with FVC being 50% or more of the predicted value.
⁃ Subjects meeting the following inclusion criteria can be assigned to Cohort 3:
⁃ 1\. Have a clear clinical subtype result at the time of enrollment.
⁃ Subjects meeting the following inclusion criteria can be assigned to Cohort 4:
• Diagnosed with stable coronary artery disease prior to or at the time of enrollment, including those with a history of coronary artery intervention or coronary artery bypass grafting for at least one year, or angiographic evidence of ≥50% stenosis in at least one coronary artery without the need for revascularization;
• C-reactive protein (CRP) or high-sensitivity CRP (hsCRP) ≥2 mg/L.