A Real-World Study of Subcutaneous Methotrexate (Pre-filled) in Chinese Rheumatoid Arthritis (RA) Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- ACR20 response rate at 24 weeks
研究概览
简要总结
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:
- 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;
- 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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •1. 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.
排除标准
- •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.
研究组 & 干预措施
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)
结局指标
主要结局
ACR20 response rate at 24 weeks
时间窗: 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).
次要结局
- 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)
- 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).(4, 12, and 24 weeks after enrollment)
研究者
Zhanguo Li
Director, Head of Rheumatology, Principal Investigator
Peking University People's Hospital