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To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TS-152 30mg SC | Experimental | TS-152 30mg subcutaneously (SC) every 4 weeks |
|
| TS-152 80mg SC | Experimental | TS-152 80mg subcutaneously (SC) every 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-152 | Drug | 30mg,80mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | To evaluate the Long-term safety of TS-152 in RA patients by incidence of adverse events which include vital signs, and clinical laboratory parameters. | through study completion, an average of 3 year |
| ACR20 | Percentage of Subjects who meet the American College of Rheumatology 20% (ACR20) Criteria from baseline of previous study (TS152-3001-JA or TS152-3001-JA). | through study completion, an average of 3 year |
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Inclusion Criteria:
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Exclusion Criteria:
etc.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39179257 | Result | Tanaka Y, Miyazaki Y, Kawanishi M, Yamasaki H, Takeuchi T. Long-term safety and efficacy of anti-TNF multivalent VHH antibodies ozoralizumab in patients with rheumatoid arthritis. RMD Open. 2024 Aug 22;10(3):e004480. doi: 10.1136/rmdopen-2024-004480. |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |