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The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAS5315 low dose group | Experimental | TAS5315 low dose and Methotrexate as specified |
|
| TAS5315 high dose group | Experimental | TAS5315 high dose and Methotrexate as specified |
|
| Placebo group | Placebo Comparator | Placebo and Methotrexate as specified |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TAS5315 low dose | Drug | Oral administration for 12 or 36 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving American College of Rheumatology 20% (ACR20) response | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who achieve ACR20 response | Up to Week 36, except for Week 12 | |
| Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response | Up to Week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taiho Pharmaceutical Co., Ltd. | Taiho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taiho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37217273 | Derived | Takeuchi T, Tanaka S, Murata M, Tanaka Y. Irreversible covalent Bruton's tyrosine kinase inhibitor, TAS5315 versus placebo in rheumatoid arthritis patients with inadequate response to methotrexate: a randomised, double-blind, phase IIa trial. Ann Rheum Dis. 2023 Aug;82(8):1025-1034. doi: 10.1136/ard-2022-223759. Epub 2023 May 22. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 9, 2023 | |
| Reset | Mar 28, 2024 | |
| Release | Jun 28, 2024 | |
| Reset | Oct 10, 2024 | |
| Release | Jan 9, 2025 | |
| Reset | Feb 4, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 9, 2023 | Mar 28, 2024 | |||
| Jun 28, 2024 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| TAS5315 high dose |
| Drug |
Oral administration for 12 or 36 weeks |
|
| Placebos | Drug | Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group) |
|
| Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission | Baseline, Week 12 |
| Change from baseline in DAS28-CRP and DAS28-ESR score | Up to Week 36 |
| Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission | Baseline, Week 12 |
| Change from baseline in CDAI and SDAI score | Up to Week 36 |
| Change from baseline in patient assessment score of arthritis pain | Up to Week 36 |
| Change from baseline in patient global assessment score of arthritis | Up to Week 36 |
| Change from baseline in physician's global assessment score of arthritis | Up to Week 36 |
| Change from baseline in modified total sharp score | Baseline, Week 2, 4, 12 |
| Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels | Up to Week 36 |
| Change from baseline in rheumatoid factor levels | Up to Week 36 |
| Maximum observed plasma concentration for TAS5315 | Baseline, Week 2, 4, 12 |
| Time to reach the maximum plasma concentration for TAS5315 | Baseline, Week 2, 4, 12 |
| Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315 | Baseline, Week 2, 4, 12 |
| Incidence of adverse events and side effects as safety | Up to Week 36 |
| Oct 10, 2024 |
| Jan 9, 2025 | Feb 4, 2025 |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |