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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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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| 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 |
| 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). |
| 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) |
Inclusion Criteria:
Additionally, subjects meeting the following inclusion criteria can be assigned to Cohort 2:
Inclusion Criteria:
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:
Exclusion Criteria:
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The study includes adult RA patients treated with subcutaneous MTX.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| XU LIU, MD | Contact | 010-88325223 | liuxupkupku@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| 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 |
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] |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |