NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs071200007

Registered date:20/04/2020

Discontinuation of biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving sustained clinical remission or low disease activity during the IFX SIRIUS STUDY I (the IFX-SIRIUS STUDY II): Study protocol for an interventional, multicenter ,open label, single arm clinical trial with clinical, ultrasound and biomarker assessments

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedRheumatoid arthritis
Date of first enrollment28/01/2021
Target sample size80
Countries of recruitment
Study typeInterventional
Intervention(s)Rheumatoid arthritis patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS. If they have relapse after discontinuation of infliximab BS,infliximab BS will be re-administered.

Outcome(s)

Primary OutcomeClinical relapse rate
Secondary OutcomeChanges of total power Doppler (PD) score by musculoskeletal ultrasound. Changes of total gray scale (GS) score by musculoskeletal ultrasound. Changes of combined score by musculoskeletal ultrasound. Changes of DAS28-ESR. Changes of DAS28-CRP.

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteria1.Patients who have been treated with infliximab BS during IFX-SIRIUS STUDY I . 2.Patients who have been persisted with clinical remission or low disease activity during IFX-SIRIUS STUDY I period and the baseline visit. 3.Patients who give written informed consent after receiving sufficient information.
Exclude criteria1.Patients with a history of infusion reaction to infliximab BS required medication. 2.Patients changed the dosage of restricted drugs after IFX-SIRIUS STUDY I period. 3.Patients treated with prohibited substances or prohibited therapy after IFX-SIRIUS STUDY I period. 4.Women who detect a pregnancy after IFX-SIRIUS STUDY I period. 5.Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the study period and lactating women. Men who will not be compliant with a contraceptive regimen during the study period. 6.Patients who are judged unsuitable for this study by the investigator.

Related Information

Contact

Public contact
Name Shinya Kawashiri
Address 1-7-1 Sakamoto, Nagasaki Nagasaki Japan 852-8501
Telephone +81-958197200
E-mail shin-ya@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital
Scientific contact
Name Atsushi Kawakami
Address 1-7-1 Sakamoto, Nagasaki Nagasaki Japan 852-8501
Telephone +81-958197200
E-mail atsushik@nagasaki-u.ac.jp
Affiliation Nagasaki University Hospital