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

JRCT ID: jRCTs071200054

Registered date:18/11/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 18/11/2020
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Rheumatoid arthritis patients with moderate or high disease activity will be introduce for etanercept BS "MA" within 14 days of case enrollment. The etanercept BS "MA" is given as a weekly subcutaneous injection of 50 mg for 24 weeks.

Outcome(s)

• Primary Outcome: Changes from baseline to 24 weeks in the Global OMERACT-EULAR Synovitis Score (GLOESS) by musculoskeletal ultrasound (MSUS) for bilateral 2nd-5th metacarpophalangeal (MCP) joints.

Secondary Outcome

The proportion of study participants meeting low disease activity/remission criteria at 12 and 24 weeks.
Changes in total power Doppler (PD) score by MSUS from baseline to 12 and 24 weeks.
Changes in total gray scale (GS) score by MSUS from baseline to 12 and 24 weeks.
Changes in GLOESS by MSUS from baseline to 12 weeks.
Changes in DAS28-ESR from baseline to 12 and 24 weeks.
Changes in DAS28-CRP from baseline to 12 and 24 weeks.
Changes in SDAI from baseline to 12 and 24 weeks.
Changes in CDAI from baseline to 12 and 24 weeks.
Changes in mTSS from baseline to 24 weeks.
Changes in HAQ-DI from baseline to 12 and 24 weeks.
Changes in biomarker from baseline to 12 and 24 weeks.
SRM (standardized response mean) of total PD score at 12 and 24 weeks.
SRM of total GS score at 12 and 24 weeks.
SRM of GLOESS at 12 and 24 weeks.
SRM of DAS28-ESR at 12 and 24 weeks.
SRM of DAS28-CRP at 12 and 24 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 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.

Exclude criteria

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.

Related Information

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