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

JRCT ID: jRCTs071200007

Registered date:20/04/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Rheumatoid arthritis
• Date of first enrollment: 20/04/2020
• Target sample size: 80
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: Clinical relapse rate

Secondary Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Kawakami Atsushi
• Source(s) of Monetary Support: Celltrion Healthcare HQ.