Subcutaneous methotrexate for Chinese adults with rheumatoid arthritis

A Real-World Study of Subcutaneous Methotrexate (Pre-filled) in Chinese Rheumatoid Arthritis (RA) Patients

This project will test how well and how safely subcutaneous methotrexate works for Chinese adults with rheumatoid arthritis, including people with lung or coronary comorbidities.

Quick facts

• Study type: Observational
• Enrollment: 10000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: methotrexate
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07463937 on ClinicalTrials.gov

What this trial studies

This is a prospective, single‑arm, multicenter real‑world observational study that does not change patients' prescribed treatments. It enrolls adults with RA who are starting subcutaneous methotrexate and follows them during routine care to collect safety and effectiveness outcomes. Participants are organized into cohorts including a large general RA cohort (about 8,000 patients), a cohort with ILD or ILAs (about 200 patients), and cohorts defined by clinical subtypes or stable coronary artery disease. Data are collected from clinical visits, pulmonary function tests, and standard safety monitoring to reflect everyday clinical practice in China.

Who should consider this trial

Good fit: Adults diagnosed with RA by ACR criteria who are starting or preparing to start subcutaneous methotrexate, can give informed consent, and can attend follow‑up visits are the intended participants.

Not a fit: People who are not initiating subcutaneous methotrexate, who have severe pulmonary impairment (FVC <50%), or who cannot complete follow‑up visits are unlikely to benefit from joining this study.

Why it matters

Potential benefit: If positive, the results could reassure patients and clinicians that subcutaneous methotrexate is effective and safe in everyday care for Chinese RA patients, including those with certain lung or heart comorbidities.

How similar studies have performed: Subcutaneous methotrexate has demonstrated effectiveness and acceptable safety in prior clinical and observational studies, but large-scale real‑world data in Chinese RA populations and in those with ILD/ILAs remain limited.

Eligibility criteria

Inclusion Criteria:

1. Adult patients diagnosed with rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR classification criteria.
2. Patients who, after clinical evaluation, are starting or preparing to start subcutaneous methotrexate treatment, with expected benefits outweighing the risks.
3. 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:

Inclusion Criteria:

1. Diagnosed with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs) prior to or at the time of enrollment;
2. 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:

1. 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;
2. C-reactive protein (CRP) or high-sensitivity CRP (hsCRP) ≥2 mg/L.

Exclusion Criteria:

1. Pregnant or breastfeeding women;
2. Serum creatinine: Female patients with serum creatinine \>1.4 mg/dL (124 μmol/L); male patients with serum creatinine \>1.6 mg/dL (141 μmol/L); patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.5 times the upper limit of normal (ULN);
3. Platelet count \<80×10\^9/L; white blood cell (WBC) count \<3.5×10\^9/L; total bilirubin \>1.5 times the ULN;
4. Presence of severe, uncontrolled comorbid conditions, such as (but not limited to) neurological, cardiovascular, hepatic, renal, gastrointestinal, or endocrine diseases, which in the investigator's judgment may interfere with the patient's participation in the study;
5. Patients with a history of malignancy within the past 5 years;
6. Cardiac diseases: decompensated heart failure or refractory hypertension (hypertension that cannot be controlled to target levels of systolic and diastolic blood pressure despite lifestyle modifications and adequate doses of at least three antihypertensive drugs, including diuretics);
7. Patients with significant or laboratory-confirmed immunodeficiency syndromes;
8. Patients with severe acute or chronic infections;
9. Patients with pre-existing hematologic disorders, such as myelodysplasia, leukopenia, thrombocytopenia, or anemia;
10. Patients allergic to the study-related drug;
11. Patients with a history of drug abuse, mental illness, or alcoholism, who cannot cooperate with clinical researchers;
12. Other patients deemed unsuitable for participation in the study by the investigator.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: XU LIU, MD

Conditions: Rheumatoid Arthritis