RecruitingNCT07463937

A RWS of SC MTX in Chinese RA Patients

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


Sponsor

Peking University People's Hospital

Enrollment

10,000 participants

Start Date

Sep 3, 2024

Study Type

OBSERVATIONAL

Conditions

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. 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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how well subcutaneous methotrexate (an injectable form of a common rheumatoid arthritis drug, given under the skin rather than by mouth) works in real-world Chinese patients with rheumatoid arthritis. A subgroup of patients with lung involvement will also be followed closely. **You may be eligible if...** - You are an adult diagnosed with rheumatoid arthritis (RA) - Your doctor has decided that subcutaneous methotrexate is appropriate for your treatment - You agree to participate and attend follow-up visits - (For the lung subgroup) You have been diagnosed with interstitial lung disease or lung abnormalities and have adequate lung function **You may NOT be eligible if...** - You have not been diagnosed with rheumatoid arthritis - Your doctor has not recommended subcutaneous methotrexate for you - You are unwilling to comply with the study protocol Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT07463937


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