Clinical trial NCT03275025: A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: Yungjin Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-09-07
Enrollment: 116
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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:

  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

Primary outcomes:
measure: American College of Rheumatology 20 (ACR20) response rate at Week 12
timeFrame: Week 12
measure: Percentage of Participants With Adverse Events
timeFrame: Week 12
Secondary outcomes:
measure: ACR20 Response at Week 4,8
timeFrame: Week 4 and 8
measure: Change From Baseline in Patient Assessment of Pain Visual Analog Scale (VAS) at Week 4,8 and 12
timeFrame: Week 4,8 and 12
measure: ACR 50, 70 Response at Week 4, 8 and 12
timeFrame: Week 4, 8 and 12
measure: Mean Percent Change From Baseline in the Swollen Joint Count(SJC) and Tender Joint Count (TJC) at Week 4, 8 and 12
timeFrame: Week 4, 8 and 12
measure: Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12
timeFrame: Week 4, 8 and 12
measure: Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12
timeFrame: Weeks 4, 8 and 12
measure: Mean Change from Baseline in Assessment of participant's illness at Week 4, 8 and 12 by participants and investigator/sub-investigator
timeFrame: Week 4, 8 and 12
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Jongno-gu
city: Anyang
country: Korea, Republic of
facility: Hanllym University Medical Center
city: Chungju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kelmyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gangdong
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: KyungHee University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: YeongWook Song, M.D.,Ph.D.
role: STUDY_CHAIR
References: