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

NCT03275025 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2021-05-03

No results posted yet for this study

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).

Conditions

Interventions

DRUG

YRA-1909 low dose

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

DRUG

YRA-1909 mid dose

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

DRUG

YRA-1909 high dose

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

DRUG

Placebo

Matching placebo dosing with daily oral intake for 12 weeks

Sponsors & Collaborators

  • Yungjin Pharm. Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • YeongWook Song, M.D.,Ph.D. · Seoul National University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2019-11-19
Completion
2019-11-19

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03275025 on ClinicalTrials.gov