Back to resultsBucillamine Study of Holding Remission After Infliximab Dose-off
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
bucillamine
methotrexate
Sponsored by
About this trial
This is an interventional prevention trial for Rheumatoid Arthritis
Eligibility 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
Sites / Locations
- Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
The rate of disease flare
Secondary Outcome Measures
Full Information
NCT ID
NCT00716248
First Posted
July 8, 2008
Last Updated
January 4, 2011
Sponsor
Saitama Medical University
Collaborators
Keio University
1. Study Identification
Unique Protocol Identification Number
NCT00716248
Brief Title
Bucillamine Study of Holding Remission After Infliximab Dose-off
Official Title
The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Saitama Medical University
Collaborators
Keio University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
bucillamine
Intervention Description
bucillamine 100 mg, twice a day
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
methotrexate 6 mg or more per week
Primary Outcome Measure Information:
Title
The rate of disease flare
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University
City
Kawagoe
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Bucillamine Study of Holding Remission After Infliximab Dose-off
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