Massive study tracks methotrexate in 10,000 arthritis patients
NCT ID NCT07463937
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is tracking 10,000 Chinese adults with rheumatoid arthritis who are starting or continuing a drug called subcutaneous methotrexate. Researchers want to see how well it works and how safe it is in everyday medical practice, including in patients with additional lung or heart problems. The study does not change the patient's treatment plan, just observes their progress over 24 weeks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 10,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study includes adult RA patients treated with subcutaneous MTX.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University People's Hospital
RECRUITINGBeijing, Beijing Municipality, 100044, China
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Other studies related to the condition(s) this trial covers.
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