Phase I/II study of subcutaneous injection of MRA
Phase 1
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCT2080220688
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 32
Inclusion Criteria
Patients with RA diagnosed according to the revised 1987 ACR. 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 or immunosuppressant.
Exclusion Criteria
Patients who are treated with biologics and/or leflunomide within 6 weeks before treatment.
Patient's WBC, Neutrophil count and lymphocyte count are less than 3500, 1000 and 500/microL, respectively.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method