SMOOTH Study

JRCT ID: jRCTs031210471

Registered date:06/12/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid Arthritis
• Date of first enrollment: 18/02/2022
• Target sample size: 40
• Study type: Interventional
• Intervention(s): Subcutaneous Injection

Outcome(s)

• Primary Outcome: Change from baseline, a day of switch to ETN-BS 50mg/week, in 28-joint disease activity score using erythrocyte sedimentation rate (DAS28-ESR) at week 24.

Secondary Outcome

1) Change from baseline in DAS28-ESR at week 12 and 52.
2)DAS28-ESR, Simplified Disease Activity Index (SDAI), and Clinical Disease Activity Index (CDAI), change from baseline in SDAI and CDAI at week 12, 24, and 52.
3)Retention rate of subjects treated with ETN-BS at week 12, 24, and 52.
4)Health Assessment Questionnaire (HAQ) and EuroQol 5-Dimension (EQ-5D) at baseline, week 12, 24, and 52.
5) changes from baseline in the components of DAS28-ESR (tender and swollen joints, ESR, and visual analog scale for general health) and in HAQ and EQ-5D at week 12, 24, 52.
6) Relationship between the serum biomarker and delta-DAS28-ESR at week 12, 24, and 52.
7) Relationship between the blood concentration of ETN-BS, anti-ETN antibody and the change from baseline in disease activity.
8)Incidence of adverse events which include exacerbation of complications, clinical laboratory parameters and injection site reaction.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients must meet all of the following requirements to be considered for entry into the study:
Patients initiated with Etanercept-Reference Product (ETN-RP) at per their physician's therapeutic decision
Treated for a minimum 24 weeks with a stable dose of ETN-RP(less than or equal to 25mg/week)
With at least Low Disease Activity at the eligibility evaluation
Give written informed consent after receiving sufficient information, including a switch to Etanercept-biosimilar (ETN-BS) 50mg/week
2)Diagnosed with rheumatoid arthritis (RA) under the 1987 American College of Rheumatology (ACR) or 2010 ACR/European League Against Rheumatism (EULAR) criteria
3)Met the guidelines for the proper use of TNF-alfa inhibitors in Japan (Japan College of Rheumatology, 2018)
4)Patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study

Exclude criteria

Subject has a medical condition, such as sepsis or septic shock, and many risk factors for sepsis
Active infection of any kind
Subject has active tuberculosis
Subject has a history of an allergic reaction or significant sensitivity to constituents of study drugs
Subject has a history of active demyelinating disease, including multiple sclerosis.
Subject has a poorly controlled congestive heart failure.
Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Related Information

• Primary Sponsor: Yamaoka Kunihiro
• Source(s) of Monetary Support: AYUMI Pharmaceutical Corporation