Bucillamine Study of Holding Remission After Infliximab Dose-off

Rheumatoid Arthritis Clinical Trial

Official title:

The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00716248
• Other study ID #: SMC-94
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 8, 2008
• Last updated: January 4, 2011
• Start date: January 2007

Study information

• Verified date: September 2009
• Source: Saitama Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Japan	Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University	Kawagoe	Saitama

Sponsors (2)

Lead Sponsor	Collaborator
Saitama Medical University	Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of disease flare		2 years	No