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

Yungjin Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: YRA-1909 low dose; Drug: YRA-1909 mid dose; Drug: YRA-1909 high dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03275025

YJ15-201

Details and patient eligibility

About

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).

Enrollment: 116 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 4 patient groups, including a placebo group

YRA-1909 low dose

Experimental group

Treatment:

Drug: YRA-1909 low dose

Drug: Placebo

YRA-1909 medium does

Experimental group

Treatment:

Drug: YRA-1909 mid dose

Drug: Placebo

YRA-1909 high dose

Experimental group

Treatment:

Drug: YRA-1909 high dose

YRA-1909 Placebo

Placebo Comparator group

Treatment:

Drug: Placebo