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

April 29, 2021 updated by: Yungjin Pharm. Co., Ltd.

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)

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Anyang, Korea, Republic of
        • Hanllym University Medical Center
      • Chungju, Korea, Republic of
        • Chungbuk National University Hospital
      • Daegu, Korea, Republic of
        • Kelmyung University Dongsan Medical Center
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Gangdong, Korea, Republic of
        • Kyung Hee University Hospital at Gangdong
      • Gwangju, Korea, Republic of
        • Chonnam National University Hospital
      • Incheon, Korea, Republic of
        • Gachon University Gil Medical Center
      • Jeonju, Korea, Republic of
        • Chonbuk National University Hospital
      • Seongnam, Korea, Republic of
        • Seoul National University Bundang Hospital
      • Seoul, Korea, Republic of
        • KyungHee University Hospital
      • Seoul, Korea, Republic of
        • Hanyang University Seoul Hospital
      • Seoul, Korea, Republic of
        • Seoul Metropolitan Goverment Seoul National Univeersity Boramae Medical Center
      • Suwon, Korea, Republic of
        • Ajou University Hospital
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 110744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: YRA-1909 low dose
Drug: Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Drug: YRA-1909 low dose
A low dose of YRA-1909; daily oral intake for 12 weeks
Experimental: YRA-1909 medium does
Drug: Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Drug: YRA-1909 mid dose
A mid dose of YRA-1909; daily oral intake for 12 weeks
Experimental: YRA-1909 high dose
Drug: YRA-1909 high dose
A high dose of YRA-1909; daily oral intake for 12 weeks
Placebo Comparator: YRA-1909 Placebo
Drug: Placebo
Matching placebo dosing with daily oral intake for 12 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
American College of Rheumatology 20 (ACR20) response rate at Week 12
Time Frame: Week 12
Week 12
Percentage of Participants With Adverse Events
Time Frame: Week 12
Incidence of all grade adverse events
Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
ACR20 Response at Week 4,8
Time Frame: Week 4 and 8
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
Week 4,8 and 12
ACR 50, 70 Response at Week 4, 8 and 12
Time Frame: 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
Time Frame: Week 4, 8 and 12
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
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
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
Week 4, 8 and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yungjin Pharm. Co., Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: YeongWook Song, M.D.,Ph.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YJ15-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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