Bucillamine Study of Holding Remission After Infliximab Dose-off

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00716248

Enrollment

Registered

2008-07-16

Start date

2007-01-31

Completion date

Unknown

Last updated

2011-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

DRUGbucillamine

bucillamine 100 mg, twice a day

DRUGmethotrexate

methotrexate 6 mg or more per week

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The rate of disease flare	2 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026