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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071190030

Enrollment

Registered

2019-10-11

Start date

2020-07-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis

Interventions

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 i

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Clinical relapse rate	—

Secondary

Measure	Time frame
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.	—

Contacts

Public ContactShinya Kawashiri

Nagasaki University Hospital

shin-ya@nagasaki-u.ac.jp+81-95-819-7200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026