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

Study Overview
=================
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).

Official Title
-----------------
A Multicenter, Randomized, Double-blind, Placebo-controlled, Therapeutic Exploratory, Phase II Clinical Trial for the Efficacy Investigation and Safety Evaluation 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)

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: YRA-1909 low dose
* Drug: YRA-1909 mid dose
* Drug: YRA-1909 high dose
* Drug: Placebo


Participation Criteria
=================
Eligibility 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: 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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YRA-1909 low dose<br> | Drug: YRA-1909 low dose<br>* A low dose of YRA-1909; daily oral intake for 12 weeks<br>Drug: Placebo<br>* Matching placebo dosing with daily oral intake for 12 weeks<br>|
| Experimental: YRA-1909 medium does<br> | Drug: YRA-1909 mid dose<br>* A mid dose of YRA-1909; daily oral intake for 12 weeks<br>Drug: Placebo<br>* Matching placebo dosing with daily oral intake for 12 weeks<br>|
| Experimental: YRA-1909 high dose<br> | Drug: YRA-1909 high dose<br>* A high dose of YRA-1909; daily oral intake for 12 weeks<br>|
| Placebo Comparator: YRA-1909 Placebo<br> | Drug: Placebo<br>* Matching placebo dosing with daily oral intake for 12 weeks<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology 20 (ACR20) response rate at Week 12 |  | Week 12 | 
| Percentage of Participants With Adverse Events | Incidence of all grade adverse events | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| ACR 50, 70 Response 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 | 
| 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 |