Status:
COMPLETED
A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
Lead Sponsor:
Yungjin Pharm. Co., Ltd.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
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 Methotrex...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT03275025
Start Date
April 1 2017
End Date
November 19 2019
Last Update
May 3 2021
Active Locations (14)
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1
Seoul National University Hospital
Seoul, Jongno-gu, South Korea, 110744
2
Hanllym University Medical Center
Anyang, South Korea
3
Chungbuk National University Hospital
Chungju, South Korea
4
Kelmyung University Dongsan Medical Center
Daegu, South Korea