Phase III study of MRA-SC 162 mg/week
Phase 3
- Conditions
- Rheumatoid arthritis
- Registration Number
- JPRN-jRCT2080222455
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 50
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
(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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in DAS28<br><br>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 Outcome Measures
Name Time Method Efficacy and safety<br><br>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