A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
NCT ID: NCT03275025
Last Updated: 2021-05-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2017-04-01
2019-11-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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YRA-1909 low dose
YRA-1909 low dose
A low dose of YRA-1909; daily oral intake for 12 weeks
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
YRA-1909 medium does
YRA-1909 mid dose
A mid dose of YRA-1909; daily oral intake for 12 weeks
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
YRA-1909 high dose
YRA-1909 high dose
A high dose of YRA-1909; daily oral intake for 12 weeks
YRA-1909 Placebo
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Interventions
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YRA-1909 low dose
A low dose of YRA-1909; daily oral intake for 12 weeks
YRA-1909 mid dose
A mid dose of YRA-1909; daily oral intake for 12 weeks
YRA-1909 high dose
A high dose of YRA-1909; daily oral intake for 12 weeks
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Any of the following laboratory values at screening:
1. Patients with severe liver impairment (AST or ALT \> 2 times the upper limit of normal)
2. Patients with renal disease,immunodeficiency disease and peptic ulcer
3. Patients with pleural effusion and ascites
19 Years
80 Years
ALL
No
Sponsors
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Yungjin Pharm. Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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YeongWook Song, M.D.,Ph.D.
Role: STUDY_CHAIR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, Jongno-gu, South Korea
Hanllym University Medical Center
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
Countries
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Other Identifiers
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YJ15-201
Identifier Type: -
Identifier Source: org_study_id
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