NCT00716248

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 8, 2008

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 16, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Last Updated

January 5, 2011

Status Verified

September 1, 2009

Enrollment Period

4.9 years

First QC Date

July 8, 2008

Last Update Submit

January 4, 2011

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • The rate of disease flare

    2 years

Study Arms (2)

1

EXPERIMENTAL
Drug: bucillamineDrug: methotrexate

2

ACTIVE COMPARATOR
Drug: methotrexate

Interventions

bucillamineDRUG

bucillamine 100 mg, twice a day

1
methotrexateDRUG

methotrexate 6 mg or more per week

12

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Previously teated with bucillamine
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University

Kawagoe, Saitama, 350-8550, Japan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

bucillamineMethotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 16, 2008

Study Start

January 1, 2007

Primary Completion

December 1, 2011

Last Updated

January 5, 2011

Record last verified: 2009-09

Locations

JP(1)