Bucillamine Study of Holding Remission After Infliximab Dose-off

Saitama Medical University40 enrolled

Overview

Patients with rheumatoid arthritis who have been well controlled with methotrexate plus infliximab may remain in remission or low disease activity without infliximab. And the chance of sustained remission increase by the addition of another DMARD, bucillamine, at the time of discontinuing infliximab. The BuSHIDO trial is the prospective, randomized, controlled study comparing MTX monotherapy and MTX plus bucillamine combination therapy as to the rate of disease flare after discontinuing infliximab.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

bucillamineDRUG

bucillamine 100 mg, twice a day

methotrexateDRUG

methotrexate 6 mg or more per week

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * RA according to American College of Radiology (ACR) classification criteria * Age of 20 or greater * DAS28-ESR \< 3.2 or DAS28-CRP \< 2.6 for more than 6 months Exclusion Criteria: * Previously teated with bucillamine * Pregnancy or lactation

Locations (1)

Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University

Kawagoe, Saitama, Japan

Outcomes

Primary Outcomes

The rate of disease flare

Time frame: 2 years

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.