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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03275025
Recruitment Status : Completed
First Posted : September 7, 2017
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Yungjin Pharm. Co., Ltd.

Study Description
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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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: YRA-1909 low dose Drug: YRA-1909 mid dose Drug: YRA-1909 high dose Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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)
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : November 19, 2019
Actual Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: YRA-1909 low dose Drug: YRA-1909 low dose
A low dose of YRA-1909; daily oral intake for 12 weeks

Drug: Placebo
Matching placebo dosing with daily oral intake for 12 weeks
Experimental: YRA-1909 medium does Drug: YRA-1909 mid dose
A mid dose of YRA-1909; daily oral intake for 12 weeks

Drug: Placebo
Matching placebo dosing with 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


Outcome Measures
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Primary Outcome Measures :
  1. American College of Rheumatology 20 (ACR20) response rate at Week 12 [ Time Frame: Week 12 ]
  2. Percentage of Participants With Adverse Events [ Time Frame: Week 12 ]
    Incidence of all grade adverse events


Secondary Outcome Measures :
  1. ACR20 Response at Week 4,8 [ Time Frame: Week 4 and 8 ]
  2. 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 ]
  3. ACR 50, 70 Response at Week 4, 8 and 12 [ Time Frame: Week 4, 8 and 12 ]
  4. 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 ]
  5. Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Week 4, 8 and 12 [ Time Frame: Week 4, 8 and 12 ]
  6. Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) at Week 4, 8 and 12 [ Time Frame: Weeks 4, 8 and 12 ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275025


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Jongno-gu, Korea, Republic of, 110744
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
Ajou University Hospital
Suwon, Korea, Republic of
Sponsors and Collaborators
Yungjin Pharm. Co., Ltd.
Investigators
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Study Chair: YeongWook Song, M.D.,Ph.D. Seoul National University Hospital
More Information
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Responsible Party: Yungjin Pharm. Co., Ltd.
ClinicalTrials.gov Identifier: NCT03275025    
Other Study ID Numbers: YJ15-201
First Posted: September 7, 2017    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases