A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: YRA-1909 low doseDrug: YRA-1909 mid doseDrug: YRA-1909 high doseDrug: Placebo
- Registration Number
- NCT03275025
- Lead Sponsor
- Yungjin Pharm. Co., Ltd.
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 19 Years to 80 Years
- Subjects with onset RA classified by ACR/EULAR 2010 revised classification criteria at least 12 weeks prior to screening
- Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class I, II or, III at screening
-
Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class Ⅳ at screening
-
Any of the following laboratory values at screening:
- Patients with severe liver impairment (AST or ALT > 2 times the upper limit of normal)
- Patients with renal disease,immunodeficiency disease and peptic ulcer
- Patients with pleural effusion and ascites
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description YRA-1909 low dose YRA-1909 low dose - YRA-1909 medium does YRA-1909 mid dose - YRA-1909 low dose Placebo - YRA-1909 Placebo Placebo - YRA-1909 medium does Placebo - YRA-1909 high dose YRA-1909 high dose -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Adverse Events Week 12 Incidence of all grade adverse events
American College of Rheumatology 20 (ACR20) response rate at Week 12 Week 12
- Secondary Outcome Measures
Name Time Method ACR 50, 70 Response at Week 4, 8 and 12 Week 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 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 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
Trial Locations
- Locations (14)
Kelmyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Chungju, Korea, Republic of
Hanllym University Medical Center
🇰🇷Anyang, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Jongno-gu, Korea, Republic of
Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Gangdong, Korea, Republic of
Hanyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
KyungHee University Hospital
🇰🇷Seoul, Korea, Republic of