Bucillamine Study of Holding Remission After Infliximab Dose-off

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saitama Medical University
• Collaborator: Keio University
• Treatments: Bucillamine; Infliximab; Methotrexate

Criteria

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