Phase III study of subcutaneous injection of MRA
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCT2080221083
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 330
Patients with RA diagnosed according to the revised 1987 ACR criteria. CRP or ESR at screening is >1mg/dL or >30 mm/h, respectively.
Non responder or inadequate response patients who receive at least one DMARD,immunosuppressant and Biologic DMARDs.
1)Patients who are treated with inflizimab , etanercept or adalimumab within 12 weeks before treatment.
2)Patients for whom the following criteria apply in tests conducted within two weeks before
treatment with the investigational product.
-WBC count:< 4000/uL
-Neutrophil count:<1000/uL
-Lymphocyte count:< 500/uL
-Platelet count:<10 x 104/uL
3) Patients who have been treated with any of the following within four weeks before treatment with the investigational product. DMARDs or immunosuppressants where the dosage regimen was changed.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method