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This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexateïŒMTXïŒin 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Placebo Comparator |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4: | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | Intravenous repeating dose |
| |
| methotrexate |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with ACR20 response. | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with ACR20, 50, and 70 response, and the components of this outcome. | very 4 Weeks, from Week 4 to Week 24 | |
| EULAR response rate. | Every 4 Weeks, from Week 4 to Week 24 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naritoshi Mochidome | Chugai Pharmaceutical | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku region | Chugoku | Japan | ||||
| Chubu region |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22247354 | Derived | Harigai M, Tanaka Y, Maisawa S; JA21963 Study Group. Safety and efficacy of various dosages of ocrelizumab in Japanese patients with rheumatoid arthritis with an inadequate response to methotrexate therapy: a placebo-controlled double-blind parallel-group study. J Rheumatol. 2012 Mar;39(3):486-95. doi: 10.3899/jrheum.110994. Epub 2012 Jan 15. |
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| Drug |
Oral repeating dose |
|
| ocrelizumabu 50mg | Drug | Intravenous repeating dose (50mg) |
|
| ocrelizumabu 200mg | Drug | Intravenous repeating dose (200mg) |
|
| ocrelizumab 500mg | Drug | Intravenous repeating dose (500mg) |
|
| DAS 28, HAQ-DI score. |
| Every 4 Weeks, from Week 4 to Week 24 |
| FACIT Fatigue Scale score | Weeks 4,12,and 24 |
| Weeks 4,12,and 24 | Length of study |
| Incidence of human anti-human(ocrelizumab) antibodies (HAHA) | Length of study |
| Pharmacokinetics and Pharmacodynamics of ocrelizumab. | Length of study |
| Chūbu |
| Japan |
| Hokkaido Region | Hokkaido | Japan |
| Kanto Region | Kanto | Japan |
| Kinki Region | Kinki | Japan |
| Kyusyu region | Kyusyu | Japan |
| Sikoku region | Sikoku | Japan |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| C533411 | ocrelizumab |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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