Bucillamine Study of Holding Remission After Infliximab Dose-off

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.

Full Title of Study: “The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2011

Interventions

  • Drug: bucillamine
    • bucillamine 100 mg, twice a day
  • Drug: methotrexate
    • methotrexate 6 mg or more per week

Arms, Groups and Cohorts

  • Experimental: 1
  • Active Comparator: 2

Clinical Trial Outcome Measures

Primary Measures

  • The rate of disease flare
    • Time Frame: 2 years

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Saitama Medical University
  • Collaborator
    • Keio University
  • Provider of Information About this Clinical Study
    • Hideto Kameda, Department of Internal Medicine, School of Medicine, Keio University

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