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

JRCT ID: jRCTs071190046

Registered date:20/02/2020

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 29/06/2020
• Target sample size: 62
• Study type: Interventional
• Intervention(s): Rheumatoid arthritis patients who have been treated with enbrel (Subcutaneous injection of 25 mg once weekly or 25 mg twice weekly or 50 mg once weekly or 50 mg once biweekly) over 24 weeks and persisted with LDA/remission are switched to the same dose of etanercept BS "MA" from enbrel. In addition, for patients receiving etanercept BS "MA" 50 mg weekly, the dose will be reduced from 24 weeks to etanercept BS "MA" 25 mg weekly to test whether LDA/remission persists until week 52.

Outcome(s)

• Primary Outcome: The proportion of study participants meeting LDA/remission criteria at 24 weeks without clinical relapse throughout the observation period.

Secondary Outcome

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.
Differences of total gray scale (GS) score by musculoskeletal ultrasound at 12, 24, 36, and 52 weeks.
Differences of combined score by musculoskeletal ultrasound at 12, 24, 36, and 52 weeks.
Differences of DAS28-ESR at 12, 24, 36, and 52 weeks.
Differences of DAS28-CRP at 12, 24, 36, and 52 weeks.
Differences of SDAI at 12, 24, 36, and 52 weeks.
Differences of CDAI at 12, 24, 36, and 52 weeks.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kawakami Atsushi
• Source(s) of Monetary Support: AYUMI Pharmaceutical Corporation