Efficacy of Etanercept Biosimilar Switching from Etanercept Reference Product, using Ultrasound and Clinical Data in Outcomes of Real World Therapy (ESCORT-NGSK Study):Study protocol for an interventional, multicenter, open-label, single-arm clinical trial

Kawakami Atsushi0 个研究点目标入组 62 人开始时间: 2020年2月20日最近更新: 2023年10月17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 have been treated Enbrel (Subcutaneous injection of 25 mg once weekly or 25 mg twice weekly or 50 mg once weekly or 50 mg once biweekly) for 24 weeks or longer and who have been in LDA/remission with no change in Enbrel dosage for at least 24 weeks prior to obtaining consent.
•4.Patients who give written informed consent after receiving sufficient information.

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

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