A RWS of SC MTX in Chinese RA Patients

NCT07463937 | Recruiting

• 1 other identifier: MTX-RWS-I
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.To evaluate the effectiveness and safety of subcutaneous MTX in RA patients with different clinical subtypes.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• ACR20 response rate at 24 weeks

  The ACR20 involves following indicators: tender joint count (TJC, 68 major joints), swollen joint count (SJC, 66 major joints), Visual Analog Score for pain (VAS), Patient Global Assessment (PGA), Estimator Global Assessment (EGA), Health Assessment Questionnaire-Disability Index (HAQ-DI), Acute-Phase Reactant (Erythrocyte Sedimentation Rate or C-Reactive Protein). ACR20 response requires: ① ≥20% improvement in TJC; ② ≥20% improvement in SJC; ③ ≥20% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).

  24 weeks after enrollment

Secondary Outcomes (7)

• ACR20 response rate at 4 and 12 weeks

  4 and 12 weeks after enrollment

• ACR50 response rates at 4, 12, and 24 weeks

  4, 12, and 24 weeks after enrollment

• ACR70 response rates at 4, 12, and 24 weeks

  4, 12, and 24 weeks after enrollment

• Improvement in DAS28 scores at 4, 12, and 24 weeks compared to baseline.

  4, 12, and 24 weeks after enrollment compared to baseline

• Improvement in CDAI scores at 4, 12, and 24 weeks compared to baseline

  4, 12, and 24 weeks after enrollment compared to baseline

Other Outcomes (4)

• The average decline in forced vital capacity (FVC) one year after enrollment compared to baseline (Cohort 2)

  1 year after enrollment compared to baseline

• Changes in the Chronic Obstructive Pulmonary Disease Assessment Test (CAT) scores at 4 weeks, 12 weeks, 24 weeks, and one year after enrollment compared to baseline (Cohort 2)

  4, 12, 24 weeks and 1 year after enrollment compared to baseline

• Time to the first acute exacerbation of interstitial lung disease (ILD) (Cohort 2)

  4 weeks, 12 weeks, 24 weeks, and 1 year after enrollment compared to baseline

Study Arms (4)

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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study includes adult RA patients treated with subcutaneous MTX.

You may qualify if:

• Adult patients diagnosed with rheumatoid arthritis according to the 1987 ACR or 2010 ACR/EULAR classification criteria.
• Patients who, after clinical evaluation, are starting or preparing to start subcutaneous methotrexate treatment, with expected benefits outweighing the risks.
• Patients who agree to participate in the study, can comply with follow-up, and sign the informed consent form.
• Diagnosed with interstitial lung disease (ILD) or interstitial lung abnormalities (ILAs) prior to or at the time of enrollment;
• Have baseline forced vital capacity (FVC) results at the time of enrollment, with FVC being 50% or more of the predicted value.
• \. Have a clear clinical subtype result at the time of enrollment.
• 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;
• C-reactive protein (CRP) or high-sensitivity CRP (hsCRP) ≥2 mg/L.

You may not qualify if:

• Pregnant or breastfeeding women;
• 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);
• Platelet count \<80×10\^9/L; white blood cell (WBC) count \<3.5×10\^9/L; total bilirubin \>1.5 times the ULN;
• 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;
• Patients with a history of malignancy within the past 5 years;
• 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);
• Patients with significant or laboratory-confirmed immunodeficiency syndromes;
• Patients with severe acute or chronic infections;
• Patients with pre-existing hematologic disorders, such as myelodysplasia, leukopenia, thrombocytopenia, or anemia;
• Patients allergic to the study-related drug;
• Patients with a history of drug abuse, mental illness, or alcoholism, who cannot cooperate with clinical researchers;
• Other patients deemed unsuitable for participation in the study by the investigator.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

XU LIU, MD

CONTACT

010-88325223; liuxupkupku@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Rheumatology, Principal Investigator

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 11, 2026
• Study Start: September 3, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

CN (1)