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Massive study tracks methotrexate in 10,000 arthritis patients

NCT ID NCT07463937

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Peking University People's Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100044, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.