Rheumatoid arthritis
Conditions
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ACR response rate ACR20% response rate at 24 weeks the initial administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy and safety esponse rate Time courses of ACR core set components Time course of DAS28 Time course of EULAR response rates Time course of ACR-N AUC Incidence and severity of adverse events | — |
Outcome results
None listed