Bucillamine Study of Holding Remission After Infliximab Dose-off

Saitama Medical University

Status and phase: Unknown; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Drug: bucillamine; Drug: methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT00716248

SMC-94

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: methotrexate

Drug: bucillamine

2

Active Comparator group

Treatment:

Drug: methotrexate