A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2019-11-19
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yungjin Pharm. Co., Ltd.
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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:

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