Rheumatoid arthritis
Conditions
Interventions
investigational material(s)
Generic name etc : MRA-SC
INN of investigational material : tocilizumab
Therapeutic category code : 639 Other biological preparations
Dosage and Administration for Investig
Sponsors
Chugai Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) RA patients diagnosed according to the American College of Rheumatology (ACR) criteria (1987). (2) Patients with inadequate response to tocilizumab subcutaneous injection 162 mg every other week.
Exclusion criteria
Exclusion criteria: (1) Patients who have been treated with any of the following within 4 weeks prior to the screening test. DMARDs or immunosuppressants where the dosage regimen was changed. (2) Patients for whom the following criteria apply at the screening test. 1) WBC count : Less than 3500/micro L 2) Neutrophil count : Less than 1000/micro L 3) Lymphocyte count : Less than 500/micro L 4) Platelet count : Less than 100,000 micro L
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in DAS28 The change in DAS28 is compared between the group of patients who received MRA-SC 162 mg QW and the group who received MRA-SC 162 mg Q2W. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy and safety Proportion of patients with DAS28 remission, CDAI change, Proportion of patients with CDAI remission, Proportion of patients with an ACR20, ACR50, ACR70 response, Change in ACR core components, Proportion of DAS28, Proportion of CDAI | — |
Outcome results
None listed