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

• Register: JPRN
• Last refreshed on: 17 October 2023
• 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: Not 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

Contacts

• Name: Shinya Kawashiri
• Affiliation: Nagasaki University Hospital

• Name: Atsushi Kawakami
• 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.

Source(s) of Monetary Support

Celltrion Healthcare HQ.

Ethics review

Status: Approval
Approval date: 17/09/2019
Contact:

[e-mail]

Nagasaki University Clinical Research Review Board

[phone]

[e-mail]