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Bucillamine Study of Holding Remission After Infliximab Dose-off

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ClinicalTrials.gov Identifier: NCT00716248
Recruitment Status : Unknown
Verified September 2009 by Saitama Medical University.
Recruitment status was:  Active, not recruiting
First Posted : July 16, 2008
Last Update Posted : January 5, 2011
Sponsor:
Collaborator:
Keio University
Information provided by:
Saitama Medical University

Tracking Information
First Submitted Date  ICMJE July 8, 2008
First Posted Date  ICMJE July 16, 2008
Last Update Posted Date January 5, 2011
Study Start Date  ICMJE January 2007
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2008)
The rate of disease flare [ Time Frame: 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bucillamine Study of Holding Remission After Infliximab Dose-off
Official Title  ICMJE The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: bucillamine
    bucillamine 100 mg, twice a day
  • Drug: methotrexate
    methotrexate 6 mg or more per week
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: bucillamine
    • Drug: methotrexate
  • Active Comparator: 2
    Intervention: Drug: methotrexate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 14, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00716248
Other Study ID Numbers  ICMJE SMC-94
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hideto Kameda, Department of Internal Medicine, School of Medicine, Keio University
Study Sponsor  ICMJE Saitama Medical University
Collaborators  ICMJE Keio University
Investigators  ICMJE Not Provided
PRS Account Saitama Medical University
Verification Date September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP