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
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCTs071200007
- Lead Sponsor
- Kawakami Atsushi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 80
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.
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.
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.