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
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCTs071190030
- Lead Sponsor
- Kawakami Atsushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical relapse rate
- Secondary Outcome Measures
Name Time Method Changes of total power Doppler (PD) score by musculoskeletal ultrasound.<br>Changes of total gray scale (GS) score by musculoskeletal ultrasound.<br>Changes of combined score by musculoskeletal ultrasound.<br>Changes of DAS28-ESR.<br>Changes of DAS28-CRP.