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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00716248
Other study ID # SMC-94
Secondary ID
Status Active, not recruiting
Phase Phase 4
First received July 8, 2008
Last updated January 4, 2011
Start date January 2007

Study information

Verified date September 2009
Source Saitama Medical University
Contact n/a
Is FDA regulated No
Health authority Japan: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 40
Est. completion date
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Drug:
bucillamine
bucillamine 100 mg, twice a day
methotrexate
methotrexate 6 mg or more per week

Locations

Country Name City State
Japan Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University Kawagoe Saitama

Sponsors (2)

Lead Sponsor Collaborator
Saitama Medical University Keio University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of disease flare 2 years No
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