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Completed

NCT Number: NCT03275025

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

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).

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Seoul National University Hospital, Seoul, Jongno-gu, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

Treatment and study plan

YRA-1909 low dose

Drug

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

YRA-1909 mid dose

Drug

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

YRA-1909 high dose

Drug

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

Placebo

Drug

Matching placebo dosing with daily oral intake for 12 weeks

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Yungjin Pharm. Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 7, 2017
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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