Actively Recruiting
A RWS of SC MTX in Chinese RA Patients
Led by Peking University People's Hospital · Updated on 2026-03-11
10000
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
A RWS of SC MTX in Chinese RA Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients diagnosed with rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR criteria
- Patients starting or preparing to start subcutaneous methotrexate treatment with expected benefit over risk
- Patients willing to participate, able to comply with follow-up, and who sign informed consent
- For Cohort 2: diagnosed with ILD or ILAs before or at enrollment, with baseline forced vital capacity (FVC) 50% or more of predicted
- For Cohort 3: have a clear clinical subtype result at enrollment
- For Cohort 4: diagnosed with stable coronary artery disease before or at enrollment, including history of coronary interventions or bypass for at least one year, or angiographic evidence of 250% stenosis in at least one coronary artery without need for revascularization
- For Cohort 4: C-reactive protein (CRP) or high-sensitivity CRP (hsCRP) 2 mg/L
You will not qualify if you...
- Pregnant or breastfeeding women
- Female patients with serum creatinine >1.4 mg/dL (124 bcmol/L) or male patients with serum creatinine >1.6 mg/dL (141 bcmol/L)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times upper limit of normal
- Platelet count <80^9/L; white blood cell count <3.5^9/L; total bilirubin >1.5 times upper limit of normal
- Severe uncontrolled comorbid conditions that may interfere with study participation
- History of malignancy within past 5 years
- Decompensated heart failure or refractory hypertension
- Significant or laboratory-confirmed immunodeficiency syndromes
- Severe acute or chronic infections
- Pre-existing hematologic disorders such as myelodysplasia, leukopenia, thrombocytopenia, or anemia
- Allergy to the study drug
- History of drug abuse, mental illness, or alcoholism interfering with cooperation
- Other conditions deemed unsuitable for participation by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
Research Team
X
XU LIU, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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