NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs031210471

Registered date:06/12/2021

SMOOTH Study

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedRheumatoid Arthritis
Date of first enrollment18/02/2022
Target sample size40
Countries of recruitment
Study typeInterventional
Intervention(s)Subcutaneous Injection

Outcome(s)

Primary OutcomeChange 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 Outcome1) 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 maximumNot applicable
GenderBoth
Include criteria1)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 criteriaSubject 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

Contact

Public contact
Name Tatsuhiko Wada
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa,JAPAN Kanagawa Japan 252-0375
Telephone +81-42-778-8111
E-mail wadatatu@med.kitasato-u.ac.jp
Affiliation Kitasato University Hospital
Scientific contact
Name Kunihiro Yamaoka
Address 1-15-1 Kitasato, Minami, Sagamihara, Kanagawa,JAPAN Kanagawa Japan 252-0375
Telephone +81-42-778-8111
E-mail yamaokak@gmail.com
Affiliation Kitasato University Hospital