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

Phase 4

• Conditions: Rheumatoid arthritis

• Registration Number: JPRN-jRCTs071190046
• Lead Sponsor: Kawakami Atsushi

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of study participants meeting LDA/remission criteria at 24 weeks without clinical relapse throughout the observation period.

Secondary Outcome Measures

Name	Time	Method
The proportion of study participants meeting LDA/remission criteria at 12 weeks, 36 weeks, 52 weeks without clinical relapse throughout the observation period Differences of total power Doppler (PD) score by musculoskeletal ultrasound at 12, 24, 36, and 52 weeks.<br>Differences of total gray scale (GS) score by musculoskeletal ultrasound at 12, 24, 36, and 52 weeks.<br>Differences of combined score by musculoskeletal ultrasound at 12, 24, 36, and 52 weeks.<br>Differences of DAS28-ESR at 12, 24, 36, and 52 weeks.<br>Differences of DAS28-CRP at 12, 24, 36, and 52 weeks.<br>Differences of SDAI at 12, 24, 36, and 52 weeks.<br>Differences of CDAI at 12, 24, 36, and 52 weeks.