Overview

This trial is active, not recruiting.

Condition rheumatoid arthritis
Treatments bucillamine, methotrexate
Phase phase 4
Sponsor Saitama Medical University
Collaborator Keio University
Start date January 2007
End date December 2011
Trial size 40 participants
Trial identifier NCT00716248, SMC-94

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
bucillamine
bucillamine 100 mg, twice a day
methotrexate
methotrexate 6 mg or more per week
(Active Comparator)
methotrexate
methotrexate 6 mg or more per week

Primary Outcomes

Measure
The rate of disease flare
time frame: 2 years

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Saitama Medical University.