Effectiveness of Etanercept Biosimilar Initiating for Etanercept -Naive Patients, using Ultrasound, Clinical and Biomarker Assessments in Outcomes of Real World Therapy(ENPORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial

Kawakami Atsushi0 个研究点目标入组 40 人开始时间: 2020年11月18日最近更新: 2024年4月23日

适应症

试验速览

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•1. Patients with 20 years older at the time of obtaining informed consent.
•2. Patients with rheumatoid arthritis (RA) fulfilled the ACR/EULAR classification criteria for RA (2010).
•3. Patients who are judged by the physician to have moderate disease activity or higher at the time of obtaining consent.
•4. Patients with DAS28-CRP > 3.2 at case enrollment.
•5. Patients who give written informed consent after receiving sufficient information.

•1. Patients under treatment with oral prednisolone >7.5 mg/day at the time of case enrollment.
•2. Patients with contraindications to etanercept BS MA.
•3. Patients who have previously used an etanercept-reference product.
•4. Patients who have previously used etanercept biosimilar.
•5. Patients under treatment with biological agents and JAK inhibitors for RA, except for denosumab.
•6. Patients whose usage and dosage of prednisolone or anti-rheumatic drugs were changed within 4 weeks prior to case enrollment.
•7. Patients who treated with prohibited drugs or prohibited therapies within 4 weeks prior to case enrollment.
•8. Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the study period and lactating women.
•9. Patients who jugged unsuitable for this study by the investigator.

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