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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 11 August 2020
Main ID:  JPRN-jRCTs071190030
Date of registration: 11/10/2019
Prospective Registration: Yes
Primary sponsor: Kawakami Atsushi
Public title: Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments
Scientific title: Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): Study protocol for an interventional, multicenter, open-label, single-arm and noninferiority clinical trial with clinical, ultrasound and biomarker assessments
Date of first enrolment: 28/07/2020
Target sample size: 80
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs071190030
Study type:  Interventional
Study design:  single arm study, open(masking not used), historical control, single assignment, treatment purpose  
Phase:  4
Countries of recruitment
Japan
Contacts
Name: Atsushi    Kawakami
Address:  1-7-1 Sakamoto, Nagasaki 852-8501 Nagasaki Japan
Telephone: +81-95-819-7200
Email: atsushik@nagasaki-u.ac.jp
Affiliation:  Nagasaki University Hospital
Name: Shinya    Kawashiri
Address:  1-7-1 Sakamoto, Nagasaki 852-8501 Nagasaki Japan
Telephone: +81-95-819-7200
Email: shin-ya@nagasaki-u.ac.jp
Affiliation:  Nagasaki University Hospital
Key inclusion & exclusion criteria
Inclusion 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 with Remicade over 24 weeks and same dosage of Remicade over 12 weeks, and persisted with clinical remission (DAS28-ESR<2.6) on the last administration date of Remicade and the baseline visit.
4.Patients who give written informed consent after receiving sufficient information.

Exclusion criteria: 1.Patients treated with more than 10mg/day of prednisolone, except for using on Remicade injection date only.
2.Patients treated with Infliximab BS previously.
3.Patients treated with biological agents and JAK inhibitors for RA, except for Remicade and Denosumab.
4.Patients with a history of infusion reaction to Remicade required medication.
5.Patients treated with corticosteroid or anti-rheumatic drugs changed the dose within 8 weeks prior to baseline visit.
6.Patients treated with prohibited substances or prohibited therapy within 8 weeks prior to baseline visit.
7.Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during and 6 months after the study period and lactating women. Men who will not be compliant with a contraceptive regimen during and 6 months after the study period.
8.Patients who jugged unsuitable for this study by the investigator.


Age minimum: >= 20age old
Age maximum: Not applicable
Gender: Both
Health Condition(s) or Problem(s) studied
Rheumatoid arthritis
Intervention(s)
Rheumatoid arthritis patients who have been treated with Remicade over 24 weeks and persisted with clinical remission are switched to infliximab BS from Remicade.
The dose and infusion intervals of infliximab BS are kept unchanged from those of Remicade.
Primary Outcome(s)
Clinical relapse rate
Secondary Outcome(s)
Changes 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.
Secondary ID(s)
Source(s) of Monetary Support
Celltrion Healthcare HQ.
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date: 17/09/2019
Contact:
gaibushikin@ml.nagasaki-u.ac.jp
Nagasaki University Clinical Research Review Board
+81-95-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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