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NCT Number: NCT07463937

A RWS of SC MTX in Chinese 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)

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location status: Recruiting

Location contact

Xu LIU, MD

CONTACT

[email protected]

010-88325223

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Additionally, subjects meeting the following inclusion criteria can be assigned to Cohort 2:

Inclusion criteria

  • 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.

Subjects meeting the following inclusion criteria can be assigned to Cohort 3:

  • Have a clear clinical subtype result at the time of enrollment.

Subjects meeting the following inclusion criteria can be assigned to Cohort 4:

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. ACR20 response rate at 24 weeks

    Time frame: 24 weeks after enrollment

    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).

Secondary outcomes

  1. ACR20 response rate at 4 and 12 weeks

    Time frame: 4 and 12 weeks after enrollment

    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).

  2. ACR50 response rates at 4, 12, and 24 weeks

    Time frame: 4, 12, and 24 weeks after enrollment

    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).

  3. ACR70 response rates at 4, 12, and 24 weeks

    Time frame: 4, 12, and 24 weeks after enrollment

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

    Time frame: 4, 12, and 24 weeks after enrollment 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

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

    Time frame: 4, 12, and 24 weeks after enrollment 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)

  6. 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.

    Time frame: 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.

  7. Safety endpoints within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).

    Time frame: 4, 12, and 24 weeks after enrollment

    Safety endpoints within 24 weeks, including the number and incidence of adverse events (AEs), serious adverse events (SAEs), and adverse drug reactions (ADRs).

Other outcomes

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

    Time frame: 1 year after enrollment compared to baseline

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

  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 (Cohort 2)

    Time frame: 4, 12, 24 weeks and 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

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

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

    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. Cohort 4 additional endpoints

    Time frame: 2 years after enrollment]

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

XU LIU, MD

CONTACT

[email protected]

010-88325223

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Acronym: MTX-RWS-I

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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