A RWS of SC MTX in Chinese RA Patients (MTX-RWS-I)

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

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

The study includes adult RA patients treated with subcutaneous MTX, divided into the following four cohorts based on comorbidities and clinical subtypes:

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)

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis (RA)

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Xu LIU, MD; Phone Number: 010-88325223; Email: liuxupkupku@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Xu LIU, MD; Phone Number: 010-88325223; Email: liuxupkupku@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study includes adult RA patients treated with subcutaneous MTX.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ACR20 response rate at 4 and 12 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).	4 and 12 weeks after enrollment
ACR50 response rates at 4, 12, and 24 weeks	The ACR50 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). ACR50 response requires: ① ≥50% improvement in TJC; ② ≥50% improvement in SJC; ③ ≥50% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).	4, 12, and 24 weeks after enrollment
ACR70 response rates at 4, 12, and 24 weeks	The ACR70 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). ACR70 response requires: ① ≥70% improvement in TJC; ② ≥70% improvement in SJC; ③ ≥70% improvement in 3 of following 5 indicators: VAS, PGA, EGA, HAQ-DI, Acute-Phase Reactant (ESR or CRP).	4, 12, and 24 weeks after enrollment
Improvement in DAS28 scores at 4, 12, and 24 weeks compared to baseline.	The DAS28 includes DAS28-ESR and DAS28-CRP. The DAS28-ESR score involves four indicators: tender joint count (TJC, 28 major joints), swollen joint count (SJC, 28 major joints), erythrocyte sedimentation rate (ESR), and patient global assessment (PGA). Calculation formula: DAS28-ESR (points) = 0.56√TJC28(points) + 0.28√SJC28(points) + 0.70×ln［ESR(mm/1h）］+ 0.014×［PGA (points)］ The DAS28-CRP score involves four indicators: tender joint count (TJC, 28 major joints), swollen joint count (SJC, 28 major joints), C-Reactive Protein (CRP), and patient global assessment (PGA). Calculation formula: DAS28-CRP (points) = 0.56√TJC28(points) + 0.28√SJC28(points) + 0.36×ln［CRP(mg/L）］+ 0.014×［PGA (points)］+0.96	4, 12, and 24 weeks after enrollment compared to baseline
Improvement in CDAI scores at 4, 12, and 24 weeks compared to baseline	The CDAI involves following indicators: tender joint count (TJC, 28 major joints), swollen joint count (SJC, 28 major joints), patient global assessment (PGA) and evaluator global assessment (EGA). Calculation formula: CDAI (points) = TJC28(points) + SJC28(points) + PGA (points) + EGA(points)	4, 12, and 24 weeks after enrollment compared to baseline
Improvement in patient global assessment (PGA), Visual Analog Score for pain (VAS), and evaluator global assessment (EGA) at 4, 12, and 24 weeks compared to baseline.	Improvement in patient global assessment (PGA), Visual Analog Score for pain (VAS), and evaluator global assessment (EGA) at 4, 12, and 24 weeks compared to baseline.	4, 12, and 24 weeks after enrollment compared to baseline
Safety endpoints within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).	Safety endpoints within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).	4, 12, and 24 weeks after enrollment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The average decline in forced vital capacity (FVC) one year after enrollment compared to baseline (Cohort 2)	The average decline in forced vital capacity (FVC) one year after enrollment compared to baseline	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)	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	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)	The definition of the first acute exacerbation of ILD will refer to the diagnostic criteria from the 2019 "Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis": unexplained worsening or dyspnea within the past 30 days; new diffuse pulmonary infiltrates or parenchymal abnormalities on chest Xray, high-resolution computed tomography (HRCT), or both since the last visit, without pneumothorax or pleural effusion; exclusion of any known causes of acute exacerbation, including infection, left heart failure, pulmonary embolism, and any identifiable causes of acute lung injury.	4 weeks, 12 weeks, 24 weeks, and 1 year after enrollment compared to baseline
Cohort 4 additional endpoints	The number and proportion of various cardiovascular events occurring within two years (including but not limited to malignant arrhythmias, heart failure, uncontrolled blood pressure, hospitalization due to various cardiovascular diseases, cardiovascular disease-related death, acute myocardial infarction, unstable angina, ischemic stroke, and ischemia-induced coronary revascularization, as well as the occurrence, diagnosis, and treatment of these conditions)	2 years after enrollment]

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: MTX-RWS-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No