JPRN-jRCT2080222455
Unknown
Phase 3
A Randomized, Double-blind, Parallel-group, Phase III Study of MRA-SC in Rheumatoid Arthritis Patients with Inadequate Response to Tocilizumab Subcutaneous Injection 162 mg every 2 weeks
ConditionsRheumatoid arthritis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Rheumatoid arthritis
- Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Enrollment
- 50
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •(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
Outcomes
Primary Outcomes
Not specified
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