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Bucillamine Study of Holding Remission After Infliximab Dose-off

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Keio University
Information provided by:
Saitama Medical University

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: bucillamine Drug: methotrexate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Bucillamine Study of Holding Remission After Infliximab Dose-off in Patients With Rheumatoid Arthritis Receiving Methotrexate
Study Start Date : January 2007
Estimated Primary Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. The rate of disease flare [ Time Frame: 2 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00716248

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

Responsible Party: Hideto Kameda, Department of Internal Medicine, School of Medicine, Keio University Identifier: NCT00716248     History of Changes
Other Study ID Numbers: SMC-94
First Posted: July 16, 2008    Key Record Dates
Last Update Posted: January 5, 2011
Last Verified: September 2009

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