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Bucillamine Study of Holding Remission After Infliximab Dose-off

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Saitama Medical University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Keio University
Information provided by:
Saitama Medical University
ClinicalTrials.gov Identifier:
NCT00716248
First received: July 8, 2008
Last updated: January 4, 2011
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: bucillamine
Drug: methotrexate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Saitama Medical University:

Primary Outcome Measures:
  • The rate of disease flare [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2007
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bucillamine
bucillamine 100 mg, twice a day
Drug: methotrexate
methotrexate 6 mg or more per week
Active Comparator: 2 Drug: methotrexate
methotrexate 6 mg or more per week

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00716248

Locations
Japan
Department of Rheumatology/Clinical Immunology, Saitama Medical Center, Saitama Medical University
Kawagoe, Saitama, Japan, 350-8550
Sponsors and Collaborators
Saitama Medical University
Keio University
  More Information

No publications provided

Responsible Party: Hideto Kameda, Department of Internal Medicine, School of Medicine, Keio University
ClinicalTrials.gov Identifier: NCT00716248     History of Changes
Other Study ID Numbers: SMC-94
Study First Received: July 8, 2008
Last Updated: January 4, 2011
Health Authority: Japan: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Infliximab
Bucillamine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

ClinicalTrials.gov processed this record on May 16, 2013