Bucillamine Study of Holding Remission After Infliximab Dose-off

Phase 4

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: bucillamine; Drug: methotrexate

• Registration Number: NCT00716248
• Lead Sponsor: Saitama Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01
• Study First Submitted: 2008-07-08
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-16
• Status Verified: 2009-09
• Last Update Submitted: 2011-01-04
• Last Update Posted: 2011-01-05
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	bucillamine	-
1	methotrexate	-
2	methotrexate	-

Primary Outcome Measures

Name	Time	Method
The rate of disease flare	2 years

Trial Locations

Locations (1)

Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University; 🇯🇵 Kawagoe, Saitama, Japan