NCT03275025

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
116

participants targeted

Target at P25-P50 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Apr 2017

Typical duration for phase_2 rheumatoid-arthritis

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 7, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 19, 2019

Completed
Last Updated

May 3, 2021

Status Verified

April 1, 2021

Enrollment Period

2.6 years

First QC Date

August 28, 2017

Last Update Submit

April 29, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (4)

YRA-1909 low dose

EXPERIMENTAL
Drug: YRA-1909 low doseDrug: Placebo

YRA-1909 medium does

EXPERIMENTAL
Drug: YRA-1909 mid doseDrug: Placebo

YRA-1909 high dose

EXPERIMENTAL
Drug: YRA-1909 high dose

YRA-1909 Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

YRA-1909 low doseDRUG

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

YRA-1909 low dose
YRA-1909 mid doseDRUG

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

YRA-1909 medium does
YRA-1909 high doseDRUG

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

YRA-1909 high dose
PlaceboDRUG

Matching placebo dosing with daily oral intake for 12 weeks

YRA-1909 PlaceboYRA-1909 low doseYRA-1909 medium does

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects meet the ACR 1992 Revised Criteria for the Classification of Global Functional Status in RA Class â…£ 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Seoul National University Hospital

Seoul, Jongno-gu, 110744, South Korea

Location

Hanllym University Medical Center

Anyang, South Korea

Location

Chungbuk National University Hospital

Chungju, South Korea

Location

Kelmyung University Dongsan Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Kyung Hee University Hospital at Gangdong

Gangdong, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Hanyang University Seoul Hospital

Seoul, South Korea

Location

KyungHee University Hospital

Seoul, South Korea

Location

Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • YeongWook Song, M.D.,Ph.D.

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2017

First Posted

September 7, 2017

Study Start

April 1, 2017

Primary Completion

November 19, 2019

Study Completion

November 19, 2019

Last Updated

May 3, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(14)