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This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YRA-1909 low dose | Experimental |
| |
| YRA-1909 medium does | Experimental |
| |
| YRA-1909 high dose | Experimental |
| |
| YRA-1909 Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YRA-1909 low dose | Drug | A low dose of YRA-1909; daily oral intake for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| American College of Rheumatology 20 (ACR20) response rate at Week 12 | Week 12 | |
| Percentage of Participants With Adverse Events | Incidence of all grade adverse events | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| ACR20 Response at Week 4,8 | Week 4 and 8 | |
| Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12 | Week 4,8 and 12 | |
| ACR 50, 70 Response at Week 4, 8 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class â…£ at screening
Any of the following laboratory values at screening:
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| Name | Affiliation | Role |
|---|---|---|
| YeongWook Song, M.D.,Ph.D. | Seoul National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | Jongno-gu | 110744 | South Korea | ||
| Hanllym University Medical Center |
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| YRA-1909 mid dose |
| Drug |
A mid dose of YRA-1909; daily oral intake for 12 weeks |
|
| YRA-1909 high dose | Drug | A high dose of YRA-1909; daily oral intake for 12 weeks |
|
| Placebo | Drug | Matching placebo dosing with daily oral intake for 12 weeks |
|
| Week 4, 8 and 12 |
| Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12 | Week 4, 8 and 12 |
| Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12 | Week 4, 8 and 12 |
| Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12 | Weeks 4, 8 and 12 |
| Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator | Week 4, 8 and 12 |
| Anyang |
| South Korea |
| Chungbuk National University Hospital | Chungju | South Korea |
| Kelmyung University Dongsan Medical Center | Daegu | South Korea |
| Chungnam National University Hospital | Daejeon | South Korea |
| Kyung Hee University Hospital at Gangdong | Gangdong | South Korea |
| Chonnam National University Hospital | Gwangju | South Korea |
| Gachon University Gil Medical Center | Incheon | South Korea |
| Chonbuk National University Hospital | Jeonju | South Korea |
| Seoul National University Bundang Hospital | Seongnam | South Korea |
| Hanyang University Seoul Hospital | Seoul | South Korea |
| KyungHee University Hospital | Seoul | South Korea |
| Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| 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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