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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs071200007

Enrollment

Registered

2020-04-20

Start date

2021-01-28

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 infliximab BS during IFX-SIRIUS STUDY I period and persisted with clinical remission or low disease activity discontinue infliximab BS. If they

Eligibility

Sex/Gender

All

Inclusion 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

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.

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+81-958197200

Outcome results

None listed

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