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

Yungjin Pharm. Co., Ltd.116 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

116

Conditions

Rheumatoid Arthritis

Interventions

YRA-1909 low doseDRUG

A low dose of YRA-1909; daily oral intake for 12 weeks

YRA-1909 mid doseDRUG

A mid dose of YRA-1909; daily oral intake for 12 weeks

YRA-1909 high doseDRUG

A high dose of YRA-1909; daily oral intake for 12 weeks

Eligibility

Sex: ALLMin age: 19 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (14)

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Hanllym University Medical Center

Anyang, South Korea

Chungbuk National University Hospital

Chungju, South Korea

Outcomes

Primary Outcomes

American College of Rheumatology 20 (ACR20) response rate at Week 12

Time frame: Week 12

Percentage of Participants With Adverse Events

Incidence of all grade adverse events

Time frame: Week 12

Secondary Outcomes

ACR20 Response at Week 4,8

Time frame: Week 4 and 8

Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12

Time frame: Week 4,8 and 12

ACR 50, 70 Response at Week 4, 8 and 12

Time frame: 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

Time frame: Week 4, 8 and 12

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12

Time frame: Week 4, 8 and 12

Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12

Time frame: 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

Time frame: Week 4, 8 and 12

Data from ClinicalTrials.gov

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