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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: 7 September 2020
Main ID:  JPRN-jRCTs071200007
Date of registration: 20/04/2020
Prospective Registration: Yes
Primary sponsor: Kawakami Atsushi
Public title: 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
Scientific title: 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
Date of first enrolment: 01/01/2021
Target sample size: 80
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs071200007
Study type:  Interventional
Study design:  single arm study, open(masking not used), active 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: +81-958197200
Email: atsushik@nagasaki-u.ac.jp
Affiliation:  Nagasaki University Hospital
Name: Shinya    Kawashiri
Address:  1-7-1 Sakamoto, Nagasaki 852-8501 Nagasaki Japan
Telephone: +81-958197200
Email: shin-ya@nagasaki-u.ac.jp
Affiliation:  Nagasaki University Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1.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.

Exclusion criteria: 1.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.


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 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.
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: 07/04/2020
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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