Actively Recruiting
A Real-World Study of Subcutaneous Methotrexate (Pre-filled) in Chinese Rheumatoid Arthritis Patients
Led by Peking University People's Hospital · Updated on 2026-03-11
10000
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of subcutaneous Methotrexate (MTX) in adult Chinese patients with rheumatoid arthritis (RA) to study its effectiveness and safety in a real-world setting. The study also explores MTX's effects in RA patients who have additional conditions such as interstitial lung disease (ILD), interstitial lung abnormalities (ILAs), or stable coronary artery disease (SCAD), and investigates different clinical subtypes of RA. This observational study will include large groups of patients divided by these conditions to better understand treatment outcomes. Participants receive subcutaneous MTX as part of their usual care without interference from the study. The study organizes patients into four cohorts: general RA patients receiving MTX, those with ILD or ILAs, those with known clinical subtype results, and patients with SCAD. Treatment follows the standard clinical plan, and the study observes how patients respond over time while continuing their regular treatment routines. During the study, participants will be monitored at 4, 12, and 24 weeks after starting MTX treatment. Researchers will assess response rates using ACR20/50/70 criteria, disease activity scores (DAS28 and CDAI), and patient and evaluator assessments for pain and overall health. Safety is also tracked by recording adverse events and drug reactions. The study aims to gather detailed data on both the benefits and risks of subcutaneous MTX in routine clinical practice, with participation lasting at least 24 weeks.
CONDITIONS
Brief 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 classification criteria
- Patients starting or preparing to start subcutaneous methotrexate treatment after clinical evaluation
- Patients who agree to participate, can comply with follow-up, and sign informed consent
- Patients with interstitial lung disease or interstitial lung abnormalities and baseline forced vital capacity (FVC) of 50% or more (for Cohort 2)
- Patients with clear clinical subtype results at enrollment (for Cohort 3)
- Patients diagnosed with stable coronary artery disease, including history of intervention or bypass grafting for at least one year, or angiographic evidence of ≥50% stenosis without need for revascularization, and CRP or hsCRP ≥2 mg/L (for Cohort 4)
You will not qualify if you...
- Pregnant or breastfeeding women
- Female patients with serum creatinine >1.4 mg/dL (124 µmol/L) or male patients with serum creatinine >1.6 mg/dL (141 µmol/L)
- ALT or AST levels greater than 1.5 times the upper limit of normal
- Platelet count less than 80×10⁹/L, white blood cell count less than 3.5×10⁹/L, or total bilirubin greater than 1.5 times the upper limit of normal
- Severe uncontrolled comorbid conditions such as neurological, cardiovascular, hepatic, renal, gastrointestinal, or endocrine diseases
- History of malignancy within the 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-related drug
- History of drug abuse, mental illness, or alcoholism interfering with study cooperation
- Other conditions deemed unsuitable for participation by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants who undergo routine care with subcutaneous methotrexate are observed for treatment response and safety.
Visits at 4, 12, and 24 weeks after enrollment
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
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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