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

Rheumatoid Arthritis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275025
• Other study ID #: YJ15-201
• Status: Completed
• Phase: Phase 2
• Start date: April 1, 2017
• Est. completion date: November 19, 2019

Study information

• Verified date: April 2021
• Source: Yungjin Pharm. Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: November 19, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 80 Years

Eligibility

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 ? 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Korea, Republic of	Hanllym University Medical Center	Anyang
Korea, Republic of	Chungbuk National University Hospital	Chungju
Korea, Republic of	Kelmyung University Dongsan Medical Center	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Gangdong
Korea, Republic of	Chonnam National University Hospital	Gwangju
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Chonbuk National University Hospital	Jeonju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Hanyang University Seoul Hospital	Seoul
Korea, Republic of	KyungHee University Hospital	Seoul
Korea, Republic of	Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Yungjin Pharm. Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology 20 (ACR20) response rate at Week 12		Week 12
Primary	Percentage of Participants With Adverse Events	Incidence of all grade adverse events	Week 12
Secondary	ACR20 Response at Week 4,8		Week 4 and 8
Secondary	Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12		Week 4,8 and 12
Secondary	ACR 50, 70 Response at Week 4, 8 and 12		Week 4, 8 and 12
Secondary	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
Secondary	Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12		Week 4, 8 and 12
Secondary	Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12		Weeks 4, 8 and 12
Secondary	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