This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate(MTX)in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with MTX in patients with active RA. The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
152
Intravenous repeating dose
Oral repeating dose
Intravenous repeating dose (50mg)
Chugoku region
Chugoku, Japan
Chubu region
Chūbu, Japan
Hokkaido Region
Hokkaido, Japan
Kanto Region
Kanto, Japan
Kinki Region
Kinki, Japan
Percentage of patients with ACR20 response.
Time frame: week 24
Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome.
Time frame: very 4 Weeks, from Week 4 to Week 24
EULAR response rate.
Time frame: Every 4 Weeks, from Week 4 to Week 24
DAS 28, HAQ-DI score.
Time frame: Every 4 Weeks, from Week 4 to Week 24
FACIT Fatigue Scale score
Time frame: Weeks 4,12,and 24
Weeks 4,12,and 24
Time frame: Length of study
Incidence of human anti-human(ocrelizumab) antibodies (HAHA)
Time frame: Length of study
Pharmacokinetics and Pharmacodynamics of ocrelizumab.
Time frame: Length of study
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Intravenous repeating dose (200mg)
Intravenous repeating dose (500mg)
Kyusyu region
Kyusyu, Japan
Sikoku region
Sikoku, Japan